Clinical Trials Logo

Clinical Trial Details — Status: Completed

Administrative data

NCT number NCT05568381
Other study ID # 2021/761
Secondary ID
Status Completed
Phase N/A
First received
Last updated
Start date April 20, 2023
Est. completion date November 17, 2023

Study information

Verified date May 2024
Source University of Sydney
Contact n/a
Is FDA regulated No
Health authority
Study type Interventional

Clinical Trial Summary

This study aims to determine the feasibility of a randomized-controlled trial of digital cognitive behavioural therapy for insomnia (CBT-I) for sleep and cognitive performance in older adults with MCI and insomnia symptoms (50-80 years). The trial will be completed online, and participants will be recruited from the community across Australia.


Description:

Insomnia is a highly prevalent sleep disorder which affect approximately 10% of the adult population and 40% of the older population. Further, insomnia has been linked to an increased risk of developing dementia. Currently, the recommended first-line treatment for insomnia is cognitive behavioural therapy for insomnia (CBT-I), in both face-to-face and digital form. Despite the strong evidence for digital CBT-I, there are insufficient data regarding the benefits and effectiveness of digital CBT-I in older people with mild cognitive impairment (MCI). The investigators will conduct a fully online study comparing 6-weeks of digital behavioural therapy for insomnia (CBT-I) against online sleep health education. Participants will be recruited using social media, as well as from memory clinics. Participants will be screened and determined eligibility and consent will be conducted online. Subsequently, participants will be randomly allocated to either digital CBT-I delivered via an application called Sleepio or wait-listed control. The Sleepio app is a sleep-improvement program that uses cognitive behavioural therapy techniques to improve insomnia symptoms. The wait-listed control will consist of 3 modules of an online Sleep Health Education package delivered fortnightly with non-tailored basic sleep information. They will be directed to a website to determine eligibility and then provided access to either the digital CBT-I (Sleepio) or the wait-listed control with a link to the first online module. At baseline, all participants will complete self-reported measures of subjective cognitive complaints, insomnia, fatigue, sleep, depression, quality of life, and digital health literacy. Also, they will complete three web-based cognitive assessments that measure memory, processing speed, and executive functioning. These will be repeated at follow-up at weeks 12


Recruitment information / eligibility

Status Completed
Enrollment 40
Est. completion date November 17, 2023
Est. primary completion date August 10, 2023
Accepts healthy volunteers No
Gender All
Age group 50 Years to 80 Years
Eligibility Inclusion Criteria: - Diagnosis of MCI as defined by a neuropsychologist. - Able to provide informed electronic consent. - Fluent English literacy. - Adults aged between 50-80 years. - Insomnia symptoms as indicated by a score >10 on the Insomnia Severity Index (ISI). - Regular computer, smartphone, or tablet use, with internet access. Exclusion Criteria: - Previous diagnosis of dementia or a score on the brief Montreal Cognitive Assessment of <18. - Previous major head injury, cerebrovascular events (stroke, TIA), or loss of consciousness = 30 minutes. - Previous or current neurological disorder diagnosis (e.g. Parkinson's, multiple sclerosis, epilepsy). - Current illicit substance use or harmful alcohol intake (Alcohol Use Disorders Identification Test Consumption (AUDIT-C) score > 8). - Current severe major depression diagnosis as defined by a score >20 on the Patient Health Questionnaire (PHQ-9) and/or suicidal ideation (score of >1 on Q9 of the PHQ-9), or severe psychiatric or developmental disorders (e.g. Schizophrenia, bipolar disorder, autism). - Major sleep disorders (e.g. narcolepsy, severe restless legs syndrome, and rapid eye movement (REM) sleep behaviour disorder) - Commencement of continuous positive airway pressure therapy, antidepressants, melatonin or engaged in CBT or psychological interventions within the prior 4 weeks. - Shift workers, recent (within 30-days) transmeridian travel. - Older adults with a risk of an increase in daytime sleepiness and decreased alertness (e.g. professional drivers or those who operate heavy machinery). - Any contraindication to sleep deprivation therapy. - Currently participating in or has participated in a research study of an investigational agent or device within 4 weeks of enrolment. - Any medication that has been used to assist sleep for three or more nights per week (e.g. benzodiazepines, sedative hypnotics, opioids) or at the discretion of the clinician.

Study Design


Intervention

Device:
digital CBT-I
Sleepio is a digital cognitive behavioral therapy (CBT) program designed to treat insomnia. The program is fully automated, and its underlying algorithms drive the delivery of information, support, and advice.
Other:
Online Sleep Health Education package
Wait-listed control participants will have full access to three online modules for the duration of the study. The information in these modules will provide non-tailored basic sleep information and content will contain text and basic images but will not be personalised to the individual participant.

Locations

Country Name City State
Australia The University of Sydney Sydney New South Wales

Sponsors (1)

Lead Sponsor Collaborator
University of Sydney

Country where clinical trial is conducted

Australia, 

References & Publications (77)

Andrieu S, Coley N, Lovestone S, Aisen PS, Vellas B. Prevention of sporadic Alzheimer's disease: lessons learned from clinical trials and future directions. Lancet Neurol. 2015 Sep;14(9):926-944. doi: 10.1016/S1474-4422(15)00153-2. Epub 2015 Jul 23. — View Citation

Australia D. Dementia Prevalence Data 2018-2058, Commissioned research undertaken by NATSEM: University of Canberra; 2018

Barnett JH, Lewis L, Blackwell AD, Taylor M. Early intervention in Alzheimer's disease: a health economic study of the effects of diagnostic timing. BMC Neurol. 2014 May 7;14:101. doi: 10.1186/1471-2377-14-101. — View Citation

Bastien CH, Vallieres A, Morin CM. Validation of the Insomnia Severity Index as an outcome measure for insomnia research. Sleep Med. 2001 Jul;2(4):297-307. doi: 10.1016/s1389-9457(00)00065-4. — View Citation

Brett J, Murnion B. Management of benzodiazepine misuse and dependence. Aust Prescr. 2015 Oct;38(5):152-5. doi: 10.18773/austprescr.2015.055. Epub 2015 Oct 1. — View Citation

Brown BM, Rainey-Smith SR, Bucks RS, Weinborn M, Martins RN. Exploring the bi-directional relationship between sleep and beta-amyloid. Curr Opin Psychiatry. 2016 Nov;29(6):397-401. doi: 10.1097/YCO.0000000000000285. — View Citation

Brown BM, Rainey-Smith SR, Villemagne VL, Weinborn M, Bucks RS, Sohrabi HR, Laws SM, Taddei K, Macaulay SL, Ames D, Fowler C, Maruff P, Masters CL, Rowe CC, Martins RN; AIBL Research Group. The Relationship between Sleep Quality and Brain Amyloid Burden. Sleep. 2016 May 1;39(5):1063-8. doi: 10.5665/sleep.5756. — View Citation

Busse A, Hensel A, Guhne U, Angermeyer MC, Riedel-Heller SG. Mild cognitive impairment: long-term course of four clinical subtypes. Neurology. 2006 Dec 26;67(12):2176-85. doi: 10.1212/01.wnl.0000249117.23318.e1. — View Citation

Buysse DJ, Reynolds CF 3rd, Monk TH, Berman SR, Kupfer DJ. The Pittsburgh Sleep Quality Index: a new instrument for psychiatric practice and research. Psychiatry Res. 1989 May;28(2):193-213. doi: 10.1016/0165-1781(89)90047-4. — View Citation

Cameron K, Williamson P, Short MA, Gradisar M. Validation of the Flinders Fatigue Scale as a measure of daytime fatigue. Sleep Med. 2017 Feb;30:105-112. doi: 10.1016/j.sleep.2016.11.016. Epub 2016 Dec 3. — View Citation

Cassidy-Eagle E, Siebern A, Unti L, Glassman J, O'Hara R. Neuropsychological Functioning in Older Adults with Mild Cognitive Impairment and Insomnia Randomized to CBT-I or Control Group. Clin Gerontol. 2018 Mar-Apr;41(2):136-144. doi: 10.1080/07317115.2017.1384777. Epub 2017 Dec 8. — View Citation

Cheng P, Luik AI, Fellman-Couture C, Peterson E, Joseph CLM, Tallent G, Tran KM, Ahmedani BK, Roehrs T, Roth T, Drake CL. Efficacy of digital CBT for insomnia to reduce depression across demographic groups: a randomized trial. Psychol Med. 2019 Feb;49(3):491-500. doi: 10.1017/S0033291718001113. Epub 2018 May 24. — View Citation

Chung F, Yegneswaran B, Liao P, Chung SA, Vairavanathan S, Islam S, Khajehdehi A, Shapiro CM. STOP questionnaire: a tool to screen patients for obstructive sleep apnea. Anesthesiology. 2008 May;108(5):812-21. doi: 10.1097/ALN.0b013e31816d83e4. — View Citation

Cross NE, Lagopoulos J, Duffy SL, Cockayne NL, Hickie IB, Lewis SJ, Naismith SL. Sleep quality in healthy older people: relationship with (1)H magnetic resonance spectroscopy markers of glial and neuronal integrity. Behav Neurosci. 2013 Oct;127(5):803-10. doi: 10.1037/a0034154. — View Citation

Cuamatzi-Castelan, A. S., Cheng, P., Fellman-Couture, C., Tallent, G., Tran, K. M., Espie, C. A., ... & Drake, C. L. (2018). 0375 Long-term Efficacy of the Sleep to Prevent Evolving Affective Disorders (SPREAD) Trial as an Internet-based Treatment for Insomnia. Sleep, 41, A143

D'Rozario AL, Chapman JL, Phillips CL, Palmer JR, Hoyos CM, Mowszowski L, Duffy SL, Marshall NS, Benca R, Mander B, Grunstein RR, Naismith SL. Objective measurement of sleep in mild cognitive impairment: A systematic review and meta-analysis. Sleep Med Rev. 2020 Aug;52:101308. doi: 10.1016/j.smrv.2020.101308. Epub 2020 Mar 13. — View Citation

de Almondes KM, Costa MV, Malloy-Diniz LF, Diniz BS. Insomnia and risk of dementia in older adults: Systematic review and meta-analysis. J Psychiatr Res. 2016 Jun;77:109-15. doi: 10.1016/j.jpsychires.2016.02.021. Epub 2016 Mar 8. — View Citation

Diamond K, Mowszowski L, Cockayne N, Norrie L, Paradise M, Hermens DF, Lewis SJ, Hickie IB, Naismith SL. Randomized controlled trial of a healthy brain ageing cognitive training program: effects on memory, mood, and sleep. J Alzheimers Dis. 2015;44(4):1181-91. doi: 10.3233/JAD-142061. — View Citation

Elcombe EL, Lagopoulos J, Duffy SL, Lewis SJ, Norrie L, Hickie IB, Naismith SL. Hippocampal volume in older adults at risk of cognitive decline: the role of sleep, vascular risk, and depression. J Alzheimers Dis. 2015;44(4):1279-90. doi: 10.3233/JAD-142016. — View Citation

Espie CA, Kyle SD, Miller CB, Ong J, Hames P, Fleming L. Attribution, cognition and psychopathology in persistent insomnia disorder: outcome and mediation analysis from a randomized placebo-controlled trial of online cognitive behavioural therapy. Sleep Med. 2014 Aug;15(8):913-7. doi: 10.1016/j.sleep.2014.03.001. Epub 2014 Mar 12. — View Citation

Espie CA, Kyle SD, Williams C, Ong JC, Douglas NJ, Hames P, Brown JS. A randomized, placebo-controlled trial of online cognitive behavioral therapy for chronic insomnia disorder delivered via an automated media-rich web application. Sleep. 2012 Jun 1;35(6):769-81. doi: 10.5665/sleep.1872. — View Citation

Freeman D, Sheaves B, Goodwin GM, Yu LM, Nickless A, Harrison PJ, Emsley R, Luik AI, Foster RG, Wadekar V, Hinds C, Gumley A, Jones R, Lightman S, Jones S, Bentall R, Kinderman P, Rowse G, Brugha T, Blagrove M, Gregory AM, Fleming L, Walklet E, Glazebrook C, Davies EB, Hollis C, Haddock G, John B, Coulson M, Fowler D, Pugh K, Cape J, Moseley P, Brown G, Hughes C, Obonsawin M, Coker S, Watkins E, Schwannauer M, MacMahon K, Siriwardena AN, Espie CA. The effects of improving sleep on mental health (OASIS): a randomised controlled trial with mediation analysis. Lancet Psychiatry. 2017 Oct;4(10):749-758. doi: 10.1016/S2215-0366(17)30328-0. Epub 2017 Sep 6. — View Citation

Gauthier S, Reisberg B, Zaudig M, Petersen RC, Ritchie K, Broich K, Belleville S, Brodaty H, Bennett D, Chertkow H, Cummings JL, de Leon M, Feldman H, Ganguli M, Hampel H, Scheltens P, Tierney MC, Whitehouse P, Winblad B; International Psychogeriatric Association Expert Conference on mild cognitive impairment. Mild cognitive impairment. Lancet. 2006 Apr 15;367(9518):1262-70. doi: 10.1016/S0140-6736(06)68542-5. — View Citation

Gillis C, Mirzaei F, Potashman M, Ikram MA, Maserejian N. The incidence of mild cognitive impairment: A systematic review and data synthesis. Alzheimers Dement (Amst). 2019 Mar 8;11:248-256. doi: 10.1016/j.dadm.2019.01.004. eCollection 2019 Dec. — View Citation

Hill NT, Mowszowski L, Naismith SL, Chadwick VL, Valenzuela M, Lampit A. Computerized Cognitive Training in Older Adults With Mild Cognitive Impairment or Dementia: A Systematic Review and Meta-Analysis. Am J Psychiatry. 2017 Apr 1;174(4):329-340. doi: 10.1176/appi.ajp.2016.16030360. Epub 2016 Nov 14. — View Citation

Hu C, Yu D, Sun X, Zhang M, Wang L, Qin H. The prevalence and progression of mild cognitive impairment among clinic and community populations: a systematic review and meta-analysis. Int Psychogeriatr. 2017 Oct;29(10):1595-1608. doi: 10.1017/S1041610217000473. — View Citation

Irwin MR, Vitiello MV. Implications of sleep disturbance and inflammation for Alzheimer's disease dementia. Lancet Neurol. 2019 Mar;18(3):296-306. doi: 10.1016/S1474-4422(18)30450-2. Epub 2019 Jan 17. — View Citation

Iverson GL, Lam RW. Rapid screening for perceived cognitive impairment in major depressive disorder. Ann Clin Psychiatry. 2013 May;25(2):135-40. — View Citation

Jack CR, Wiste HJ, Botha H, Weigand SD, Therneau TM, Knopman DS, Graff-Radford J, Jones DT, Ferman TJ, Boeve BF, Kantarci K, Lowe VJ, Vemuri P, Mielke MM, Fields JA, Machulda MM, Schwarz CG, Senjem ML, Gunter JL, Petersen RC. The bivariate distribution of amyloid-beta and tau: relationship with established neurocognitive clinical syndromes. Brain. 2019 Oct 1;142(10):3230-3242. doi: 10.1093/brain/awz268. — View Citation

Kyle SD, Hurry MED, Emsley R, Marsden A, Omlin X, Juss A, Spiegelhalder K, Bisdounis L, Luik AI, Espie CA, Sexton CE. The effects of digital cognitive behavioral therapy for insomnia on cognitive function: a randomized controlled trial. Sleep. 2020 Sep 14;43(9):zsaa034. doi: 10.1093/sleep/zsaa034. — View Citation

Kyle SD, Morgan K, Spiegelhalder K, Espie CA. No pain, no gain: an exploratory within-subjects mixed-methods evaluation of the patient experience of sleep restriction therapy (SRT) for insomnia. Sleep Med. 2011 Sep;12(8):735-47. doi: 10.1016/j.sleep.2011.03.016. Epub 2011 Sep 9. — View Citation

LaMonica HM, Davenport TA, Roberts AE, Hickie IB. Understanding Technology Preferences and Requirements for Health Information Technologies Designed to Improve and Maintain the Mental Health and Well-Being of Older Adults: Participatory Design Study. JMIR Aging. 2021 Jan 6;4(1):e21461. doi: 10.2196/21461. — View Citation

LaMonica HM, English A, Hickie IB, Ip J, Ireland C, West S, Shaw T, Mowszowski L, Glozier N, Duffy S, Gibson AA, Naismith SL. Examining Internet and eHealth Practices and Preferences: Survey Study of Australian Older Adults With Subjective Memory Complaints, Mild Cognitive Impairment, or Dementia. J Med Internet Res. 2017 Oct 25;19(10):e358. doi: 10.2196/jmir.7981. — View Citation

Lezak MD, Howieson DB, Loring DW, Fischer JS. Neuropsychological assessment. Oxford University Press, USA; 2004.

Livingston G, Huntley J, Sommerlad A, Ames D, Ballard C, Banerjee S, Brayne C, Burns A, Cohen-Mansfield J, Cooper C, Costafreda SG, Dias A, Fox N, Gitlin LN, Howard R, Kales HC, Kivimaki M, Larson EB, Ogunniyi A, Orgeta V, Ritchie K, Rockwood K, Sampson EL, Samus Q, Schneider LS, Selbaek G, Teri L, Mukadam N. Dementia prevention, intervention, and care: 2020 report of the Lancet Commission. Lancet. 2020 Aug 8;396(10248):413-446. doi: 10.1016/S0140-6736(20)30367-6. Epub 2020 Jul 30. No abstract available. Erratum In: Lancet. 2023 Sep 30;402(10408):1132. — View Citation

Lovato N, Lack L, Wright H, Kennaway DJ. Evaluation of a brief treatment program of cognitive behavior therapy for insomnia in older adults. Sleep. 2014 Jan 1;37(1):117-26. doi: 10.5665/sleep.3320. — View Citation

Love S, Miners JS. Cerebrovascular disease in ageing and Alzheimer's disease. Acta Neuropathol. 2016 May;131(5):645-58. doi: 10.1007/s00401-015-1522-0. Epub 2015 Dec 28. — View Citation

Lucey BP, McCullough A, Landsness EC, Toedebusch CD, McLeland JS, Zaza AM, Fagan AM, McCue L, Xiong C, Morris JC, Benzinger TLS, Holtzman DM. Reduced non-rapid eye movement sleep is associated with tau pathology in early Alzheimer's disease. Sci Transl Med. 2019 Jan 9;11(474):eaau6550. doi: 10.1126/scitranslmed.aau6550. Erratum In: Sci Transl Med. 2020 Jan 8;12(525): — View Citation

Luik AI, Bostock S, Chisnall L, Kyle SD, Lidbetter N, Baldwin N, Espie CA. Treating Depression and Anxiety with Digital Cognitive Behavioural Therapy for Insomnia: A Real World NHS Evaluation Using Standardized Outcome Measures. Behav Cogn Psychother. 2017 Jan;45(1):91-96. doi: 10.1017/S1352465816000369. Epub 2016 Jul 26. — View Citation

Mander BA, Rao V, Lu B, Saletin JM, Lindquist JR, Ancoli-Israel S, Jagust W, Walker MP. Prefrontal atrophy, disrupted NREM slow waves and impaired hippocampal-dependent memory in aging. Nat Neurosci. 2013 Mar;16(3):357-64. doi: 10.1038/nn.3324. Epub 2013 Jan 27. — View Citation

Manea L, Gilbody S, McMillan D. Optimal cut-off score for diagnosing depression with the Patient Health Questionnaire (PHQ-9): a meta-analysis. CMAJ. 2012 Feb 21;184(3):E191-6. doi: 10.1503/cmaj.110829. Epub 2011 Dec 19. — View Citation

McKinnon A, Terpening Z, Hickie IB, Batchelor J, Grunstein R, Lewis SJ, Naismith SL. Prevalence and predictors of poor sleep quality in mild cognitive impairment. J Geriatr Psychiatry Neurol. 2014 Sep;27(3):204-11. doi: 10.1177/0891988714527516. Epub 2014 Mar 31. — View Citation

McKinnon AC, Lagopoulos J, Terpening Z, Grunstein R, Hickie IB, Batchelor J, Lewis SJ, Duffy S, Shine JM, Naismith SL. Sleep disturbance in mild cognitive impairment is associated with alterations in the brain's default mode network. Behav Neurosci. 2016 Jun;130(3):305-15. doi: 10.1037/bne0000137. Epub 2016 Mar 10. — View Citation

Meerlo P, Mistlberger RE, Jacobs BL, Heller HC, McGinty D. New neurons in the adult brain: the role of sleep and consequences of sleep loss. Sleep Med Rev. 2009 Jun;13(3):187-94. doi: 10.1016/j.smrv.2008.07.004. Epub 2008 Oct 9. — View Citation

Miller CB, Espie CA, Epstein DR, Friedman L, Morin CM, Pigeon WR, Spielman AJ, Kyle SD. The evidence base of sleep restriction therapy for treating insomnia disorder. Sleep Med Rev. 2014 Oct;18(5):415-24. doi: 10.1016/j.smrv.2014.01.006. Epub 2014 Feb 12. — View Citation

Miller, C. B., Espie, C. A., & Kyle, S. D. (2014). Cognitive behavioral therapy for the management of poor sleep in insomnia disorder. ChronoPhysiology and Therapy, 4, 99.

Morin CM, Jarrin DC. Epidemiology of Insomnia: Prevalence, Course, Risk Factors, and Public Health Burden. Sleep Med Clin. 2022 Jun;17(2):173-191. doi: 10.1016/j.jsmc.2022.03.003. Epub 2022 Apr 23. — View Citation

Naismith SL, Glozier N, Burke D, Carter PE, Scott E, Hickie IB. Early intervention for cognitive decline: is there a role for multiple medical or behavioural interventions? Early Interv Psychiatry. 2009 Feb;3(1):19-27. doi: 10.1111/j.1751-7893.2008.00102.x. — View Citation

Naismith SL, Lewis SJ, Rogers NL. Sleep-wake changes and cognition in neurodegenerative disease. Prog Brain Res. 2011;190:21-52. doi: 10.1016/B978-0-444-53817-8.00002-5. — View Citation

Naismith SL, Mowszowski L. Sleep disturbance in mild cognitive impairment: a systematic review of recent findings. Curr Opin Psychiatry. 2018 Mar;31(2):153-159. doi: 10.1097/YCO.0000000000000397. — View Citation

Naismith SL, Pye J, Terpening Z, Lewis S, Bartlett D. "Sleep Well, Think Well" Group Program for Mild Cognitive Impairment: A Randomized Controlled Pilot Study. Behav Sleep Med. 2019 Nov-Dec;17(6):778-789. doi: 10.1080/15402002.2018.1518223. Epub 2018 Sep 24. — View Citation

Naismith SL, Rogers NL, Hickie IB, Mackenzie J, Norrie LM, Lewis SJ. Sleep well, think well: sleep-wake disturbance in mild cognitive impairment. J Geriatr Psychiatry Neurol. 2010 Jun;23(2):123-30. doi: 10.1177/0891988710363710. Epub 2010 Mar 30. — View Citation

Nasreddine ZS, Phillips NA, Bedirian V, Charbonneau S, Whitehead V, Collin I, Cummings JL, Chertkow H. The Montreal Cognitive Assessment, MoCA: a brief screening tool for mild cognitive impairment. J Am Geriatr Soc. 2005 Apr;53(4):695-9. doi: 10.1111/j.1532-5415.2005.53221.x. Erratum In: J Am Geriatr Soc. 2019 Sep;67(9):1991. — View Citation

Norman CD, Skinner HA. eHEALS: The eHealth Literacy Scale. J Med Internet Res. 2006 Nov 14;8(4):e27. doi: 10.2196/jmir.8.4.e27. — View Citation

Ohayon MM. Epidemiology of insomnia: what we know and what we still need to learn. Sleep Med Rev. 2002 Apr;6(2):97-111. doi: 10.1053/smrv.2002.0186. — View Citation

Petersen RC, Doody R, Kurz A, Mohs RC, Morris JC, Rabins PV, Ritchie K, Rossor M, Thal L, Winblad B. Current concepts in mild cognitive impairment. Arch Neurol. 2001 Dec;58(12):1985-92. doi: 10.1001/archneur.58.12.1985. — View Citation

Pillai V, Anderson JR, Cheng P, Bazan L, Bostock S, Espie CA, Roth T, Drake CL. The Anxiolytic Effects of Cognitive Behavior Therapy for Insomnia: Preliminary Results from a Web-delivered Protocol. J Sleep Med Disord. 2015;2(2):1017. Epub 2015 Feb 23. — View Citation

Rey, A. (1941). L'examen psychologique dans les cas d'encéphalopathie traumatique.(Les problems.). Archives de psychologie.

Ricker JH, Axelrod BN. Analysis of an Oral Paradigm for the Trail Making Test. Assessment. 1994 Mar;1(1):47-52. doi: 10.1177/1073191194001001007. — View Citation

Roth C. (2011) Boston Naming Test. In: Kreutzer J.S., DeLuca J., Caplan B. (eds) Encyclopedia of Clinical Neuropsychology. Springer, New York, NY. https://doi.org/10.1007/978-0-387-79948-3_869

Roth T. Insomnia: definition, prevalence, etiology, and consequences. J Clin Sleep Med. 2007 Aug 15;3(5 Suppl):S7-10. No abstract available. — View Citation

Sheikh, J. I., & Yesavage, J. A. (1986). Geriatric Depression Scale (GDS): recent evidence and development of a shorter version. Clinical Gerontologist: The Journal of Aging and Mental Health.

Shi L, Chen SJ, Ma MY, Bao YP, Han Y, Wang YM, Shi J, Vitiello MV, Lu L. Sleep disturbances increase the risk of dementia: A systematic review and meta-analysis. Sleep Med Rev. 2018 Aug;40:4-16. doi: 10.1016/j.smrv.2017.06.010. Epub 2017 Jul 6. — View Citation

Shokri-Kojori E, Wang GJ, Wiers CE, Demiral SB, Guo M, Kim SW, Lindgren E, Ramirez V, Zehra A, Freeman C, Miller G, Manza P, Srivastava T, De Santi S, Tomasi D, Benveniste H, Volkow ND. beta-Amyloid accumulation in the human brain after one night of sleep deprivation. Proc Natl Acad Sci U S A. 2018 Apr 24;115(17):4483-4488. doi: 10.1073/pnas.1721694115. Epub 2018 Apr 9. — View Citation

Smith A. Symbol digit modalities test: Manual. Los Angeles (CA): Western Psychological Services; 1982.

Sperling RA, Aisen PS, Beckett LA, Bennett DA, Craft S, Fagan AM, Iwatsubo T, Jack CR Jr, Kaye J, Montine TJ, Park DC, Reiman EM, Rowe CC, Siemers E, Stern Y, Yaffe K, Carrillo MC, Thies B, Morrison-Bogorad M, Wagster MV, Phelps CH. Toward defining the preclinical stages of Alzheimer's disease: recommendations from the National Institute on Aging-Alzheimer's Association workgroups on diagnostic guidelines for Alzheimer's disease. Alzheimers Dement. 2011 May;7(3):280-92. doi: 10.1016/j.jalz.2011.03.003. Epub 2011 Apr 21. — View Citation

Sterniczuk R, Theou O, Rusak B, Rockwood K. Sleep disturbance is associated with incident dementia and mortality. Curr Alzheimer Res. 2013 Sep;10(7):767-75. doi: 10.2174/15672050113109990134. — View Citation

Toledo JB, Arnold SE, Raible K, Brettschneider J, Xie SX, Grossman M, Monsell SE, Kukull WA, Trojanowski JQ. Contribution of cerebrovascular disease in autopsy confirmed neurodegenerative disease cases in the National Alzheimer's Coordinating Centre. Brain. 2013 Sep;136(Pt 9):2697-706. doi: 10.1093/brain/awt188. Epub 2013 Jul 10. — View Citation

Tononi G, Cirelli C. Sleep and the price of plasticity: from synaptic and cellular homeostasis to memory consolidation and integration. Neuron. 2014 Jan 8;81(1):12-34. doi: 10.1016/j.neuron.2013.12.025. — View Citation

Walker MP. Sleep, memory and emotion. Prog Brain Res. 2010;185:49-68. doi: 10.1016/B978-0-444-53702-7.00004-X. — View Citation

Wardle-Pinkston S, Slavish DC, Taylor DJ. Insomnia and cognitive performance: A systematic review and meta-analysis. Sleep Med Rev. 2019 Dec;48:101205. doi: 10.1016/j.smrv.2019.07.008. Epub 2019 Aug 12. — View Citation

Wechsler D. Wechsler Adult Intelligence Scale-Fourth Edition: Technical and interpretative manual. San Antonio (TX): Pearson Assessment; 2008.

Wechsler D. Wechsler Memory Scale. San Antonio (TX): Psychological Corporation; 1997

Winblad B, Palmer K, Kivipelto M, Jelic V, Fratiglioni L, Wahlund LO, Nordberg A, Backman L, Albert M, Almkvist O, Arai H, Basun H, Blennow K, de Leon M, DeCarli C, Erkinjuntti T, Giacobini E, Graff C, Hardy J, Jack C, Jorm A, Ritchie K, van Duijn C, Visser P, Petersen RC. Mild cognitive impairment--beyond controversies, towards a consensus: report of the International Working Group on Mild Cognitive Impairment. J Intern Med. 2004 Sep;256(3):240-6. doi: 10.1111/j.1365-2796.2004.01380.x. — View Citation

Wolkove N, Elkholy O, Baltzan M, Palayew M. Sleep and aging: 1. Sleep disorders commonly found in older people. CMAJ. 2007 Apr 24;176(9):1299-304. doi: 10.1503/cmaj.060792. — View Citation

Xie L, Kang H, Xu Q, Chen MJ, Liao Y, Thiyagarajan M, O'Donnell J, Christensen DJ, Nicholson C, Iliff JJ, Takano T, Deane R, Nedergaard M. Sleep drives metabolite clearance from the adult brain. Science. 2013 Oct 18;342(6156):373-7. doi: 10.1126/science.1241224. — View Citation

Zachariae R, Lyby MS, Ritterband LM, O'Toole MS. Efficacy of internet-delivered cognitive-behavioral therapy for insomnia - A systematic review and meta-analysis of randomized controlled trials. Sleep Med Rev. 2016 Dec;30:1-10. doi: 10.1016/j.smrv.2015.10.004. Epub 2015 Oct 24. — View Citation

* Note: There are 77 references in allClick here to view all references

Outcome

Type Measure Description Time frame Safety issue
Other Overall health status Overall health status will be assessed using the EuroQol 5-dimension scale, a brief questionnaire about health-related quality of life that queries 5 dimensions of everyday experience that are each rated using a 5-point scale (no problems/slight problems/moderate problems/severe problems/extreme problems) and the overall score range from 0 (worst health state imaginable) to 100 (best health state imaginable). Primary endpoint to test for differences is 12 weeks. baseline and at 12 weeks
Other Adherence to the online modules The digital CBT-I program provides online analytics which can be used to monitor adherence by assessing what proportion of patients in the Sleepio arm complete at least 4 sessions. Thus, adherence to the online modules will be determined using a pre-specified value of =4 sessions by 12 weeks
Other Overall engagement to digital CBT-I Overall engagement to digital CBT-I will be assessed by the User Engagement Scale Short Form (UES-SF). The UES-SF is composed of 12 questions divided between 4 domains: aesthetic appeal (AE), reward (RW), perceived usability (PU) and focused attention (FA). Overall engagement score will be calculated by adding all of the items together and dividing by twelve. The overall score ranges from 1 (low engagement) to 5 (high engagement). This is a tool that has been used to evaluate the main factors for adherence in online interventions. by 12 weeks
Other Self-report sleep quality Self-report sleep quality will be determined from the Pittsburgh Sleep Quality Index (PSQI), a 19-items questionnaire with 7 components. Each of these components produces a score ranging from 0 (no difficulty) to 3 (severe difficulty). The components scores are summed to yield a global score (range 0 - 21) with higher total score indicating worse sleep quality. Primary endpoint to test for differences is 12 weeks. baseline and at 12 weeks
Other Self-report sleep efficiency Self-report sleep efficiency will be determined from the Pittsburgh Sleep Quality Index (PSQI), a 19-items questionnaire with a global score range 0 - 21 with higher total score indicating worse sleep quality. Component 4 of the PSQI will be calculated using the question about sleep duration, bedtime and risetime and analysed as a raw percentage for differences at 12 weeks. baseline and at 12 weeks
Other Fatigue levels Fatigue levels will be determined from the Flinders Fatigue Scale (FSS), a 7 items self-report scale which assess fatigue over the past 2 weeks. This scale provides a total fatigue score ranging from 0 to 31, with higher scores indicating greater fatigue. Primary endpoint to test for differences is 12 weeks. baseline and at 12 weeks
Other Subjective cognitive complaints Subjective cognitive complaints will be determined from the British Columbia Cognitive Complaints Inventory, a 6-item screening tool that assesses perceived cognitive difficulties in the past 7 days. Each item uses a 3-point Likert scale to capture a rating (0 = not at all; 3= very much) which add up to: broadly normal (0-4); mild cognitive complaints (5-8); moderate cognitive complaints (9-14); and severe cognitive complaints (15-18). Primary endpoint to test for differences is 12 weeks. baseline and at 12 weeks
Other Target detection (number of correct hits) as assessed by the Rapid Visual Processing (RVP) test from the Cambridge Neuropsychological Test Automatic Battery (CANTAB). The RVP is a web-based test from CANTAB that measures sustained attention. The outcome is auto-calculated by CANTAB. Primary endpoint to test for differences is 12 weeks. baseline and at 12 weeks
Other Probability of False Alarm (False Alarms ÷ (False Alarms + Correct Rejections)) as assessed by the Rapid Visual Processing (RVP) test from the Cambridge Neuropsychological Test Automatic Battery (CANTAB). The RVP is a web-based test from CANTAB that measures sustained attention. The outcome is auto-calculated by CANTAB. Primary endpoint to test for differences is 12 weeks. baseline and at 12 weeks
Other New learning (number of times a subject chose the correct box on their first attempt when recalling the pattern locations. Calculated across all assessed trials) as assessed by the Paired Associate Learning (PAL) subtest from CANTAB. The PAL is a web-based test from CANTAB that assess visual memory and new learning. The outcome is auto-calculated by CANTAB. Primary endpoint to test for differences is 12 weeks. baseline and at 12 weeks
Other Problem solving (number of times that the subject chose a wrong stimulus) as assessed by Intra-Extra Dimensional Set Shift (IED) subtest from the Cambridge Neuropsychological Test Automatic Battery (CANTAB). The IED is a web-based test from CANTAB that assess executive functioning. The outcome is auto-calculated by CANTAB. Primary endpoint to test for differences is 12 weeks. baseline and at 12 weeks
Other Perseveration (number of trials for which the outcome was an incorrect response across all assessed trials) as assessed by Intra-Extra Dimensional Set Shift (IED) subtest from the Cambridge Neuropsychological Test Automatic Battery (CANTAB). The IED is a web-based test from CANTAB that assess executive functioning. The outcome is auto-calculated by CANTAB. Primary endpoint to test for differences is 12 weeks. baseline and at 12 weeks
Primary The proportion of participants who are issued a pre-screening number and then are determined to be eligible to be booked for screening. The aim is to provide feasibility data for a full-scale randomized controlled trial (RCT). We will document the number of participants who are eligible after the screening process. During Screening
Primary The proportion of participants who are issued a screening number and then are determined to be eligible for randomisation. We will document the number of participants who consent to the study after all inclusion/exclusion criteria are met. Over a 6-month period of recruitment.
Primary Percentage of participants who randomised who originally came from the memory clinic and percentage that were randomised who originally came from online recruitment. An aim of this trial is to determine the feasibility of recruiting through memory clinics and/or online advertising. We will document the number of participants who have been recruited through memory clinics or online advertising. Month 0
Secondary Insomnia symptom severity Insomnia symptoms severity will be determined from the Insomnia Severity Index (ISI), a 7-item patient reported outcome measure that probes the severity of current symptoms of insomnia over the past 2 weeks. Each item uses a 5-point Likert scale to capture a rating (0 = no problem; 4 = very severe problem) which add up to: no insomnia (0 - 7); sub-threshold insomnia (8 - 14); moderate insomnia (15 - 21); and severe insomnia (22 - 28). Primary endpoint to test for differences is 12 weeks. baseline and at 12 weeks
Secondary Target detection (A'; the accuracy with which a subject detects targets (the expected range is 0.00 to 1.00)) as assessed by the Rapid Visual Processing (RVP) test from the Cambridge Neuropsychological Test Automatic Battery (CANTAB). The RVP is a web-based test from CANTAB that measures sustained attention. The outcome is auto-calculated by CANTAB. Primary endpoint to test for differences is 12 weeks. baseline and at 12 weeks
Secondary Processing speed (median response latency in milliseconds) as assessed by the Rapid Visual Processing (RVP) test from the Cambridge Neuropsychological Test Automatic Battery (CANTAB). The RVP is a web-based test from CANTAB that measures sustained attention. The outcome is auto-calculated by CANTAB. Primary endpoint to test for differences is 12 weeks. baseline and at 12 weeks
Secondary Adjusted perseveration (number of times that the subject chose a wrong stimulus adjustment for every stage that was not reached) as assessed by Intra-Extra Dimensional Set Shift (IED) subtest from CANTAB. The IED is a web-based test from CANTAB that assess executive functioning. The outcome is auto-calculated by CANTAB. Primary endpoint to test for differences is 12 weeks. baseline and at 12 weeks
Secondary Visual memory (number of times the subject chose the incorrect box for a stimulus adjusted for the estimated number of errors on trials not completed) as assessed by the Paired Associate Learning (PAL) subtest from CANTAB. The PAL is a web-based test from CANTAB that assess visual memory and new learning. The outcome is auto-calculated by CANTAB. Primary endpoint to test for differences is 12 weeks. baseline and at 12 weeks
Secondary Problem solving (number of trials completed on all attempted stages with an adjustment for any stages not reached) as assessed by Intra-Extra Dimensional Set Shift (IED) subtest from the Cambridge Neuropsychological Test Automatic Battery (CANTAB). The IED is a web-based test from CANTAB that assess executive functioning. The outcome is auto-calculated by CANTAB. Primary endpoint to test for differences is 12 weeks. baseline and at 12 weeks
Secondary Depressive symptoms Depressive symptoms will be assessed by the Geriatric Depression Scale (GDS) which is a 15-item self-report questionnaire that has been developed to assess depressive symptoms This instrument evaluated depressive symptoms using yes/no answers. Scores range between 0 and 15 points where higher scores indicate more severe depressive symptoms. Primary endpoint to test for differences is 12 weeks. baseline and at 12 weeks
See also
  Status Clinical Trial Phase
Completed NCT04513106 - Promoting Advance Care Planning for Persons With Early-stage Dementia in the Community: a Feasibility Trial N/A
Recruiting NCT06011681 - The Rapid Diagnosis of MCI and Depression in Patients Ages 60 and Over
Recruiting NCT04522739 - Spironolactone Safety in African Americans With Mild Cognitive Impairment and Early Alzheimer's Disease Phase 4
Active, not recruiting NCT03167840 - Falls Prevention Through Physical And Cognitive Training in Mild Cognitive Impairment N/A
Active, not recruiting NCT03676881 - Longitudinal Validation of a Computerized Cognitive Battery (Cognigram) in the Diagnosis of Mild Cognitive Impairment and Alzheimer's Disease
Not yet recruiting NCT05041790 - A Clinical Trial to Evaluate the Efficacy and Safety of Choline Alfoscerate Compared to Placebo in Patients With Degenerative Mild Cognitive Impairment Phase 4
Recruiting NCT04121156 - High Definition Transcranial Direct Current Stimulation (HD-tDCS) in Patients With Mild Cognitive Impairment N/A
Recruiting NCT03605381 - MORbidity PRevalence Estimate In StrokE
Completed NCT02774083 - Cognitive Training Using Feuerstein Instrumental Enrichment N/A
Completed NCT01315639 - New Biomarker for Alzheimer's Disease Diagnostic N/A
Enrolling by invitation NCT06023446 - Can (Optical Coherence Tomography) Pictures of the Retina Detect Alzheimer's Disease at Its Earliest Stages?
Completed NCT04567745 - Automated Retinal Image Analysis System (EyeQuant) for Computation of Vascular Biomarkers Phase 1
Recruiting NCT05579236 - Cortical Disarray Measurement in Mild Cognitive Impairment and Alzheimer's Disease
Completed NCT03583879 - Using Gait Robotics to Improve Symptoms of Parkinson's Disease N/A
Terminated NCT02503501 - Intranasal Glulisine in Amnestic Mild Cognitive Impairment and Probable Mild Alzheimer's Disease Phase 2
Not yet recruiting NCT03740178 - Multiple Dose Trial of MK-4334 in Participants With Alzheimer's Clinical Syndrome (MK-4334-005) Phase 1
Active, not recruiting NCT05204940 - Longitudinal Observational Biomarker Study
Recruiting NCT02663531 - Retinal Neuro-vascular Coupling in Patients With Neurodegenerative Disease N/A
Recruiting NCT06150352 - Sleep Apnea, Neurocognitive Decline and Brain Imaging in Patients With Subjective or Mild Cognitive Impairment
Recruiting NCT03507192 - Effects of Muscle Relaxation on Cognitive Function in Patients With Mild Cognitive Impairment and Early Stage Dementia. N/A