Hypersomnia Clinical Trial
Official title:
A Multi-Signal Based Monitoring System for CNS Hypersomnias : A 10-year Longitudinal Study
NCT number | NCT05443373 |
Other study ID # | 201902163A3 |
Secondary ID | |
Status | Recruiting |
Phase | |
First received | |
Last updated | |
Start date | June 4, 2020 |
Est. completion date | July 31, 2023 |
This is a retrospective and prospective cohort study. There are 600 subjects (age 9-45) will be collected.The purposes of this study are as follows:(1) The main purpose is to use Multi-Signal Based Monitoring System to link with brain image data and perform cross-comparison to find out possible pathological mechanisms of these CNS hypersomnias.(2) Use the Multi-Signal Based Monitoring System to link with brain image data and perform cross-comparison to further screen out these clinically significant biomarkers for CNS hypersomnias, and to find ideal and accurate physiological biomarkers that can monitor the course of the disease.(3) Utilize these precisely monitored biomarkers to track changes in the biomarkers and the long-term course of these CNS hypersomnias, and evaluate the treatment effect and prognosis.(4) Use computer machine learning and other algorithms to analyze and construct a variety of faster and more accurate prediction models for these CNS hypersomnias, thereby achieving the goal of preventive medicine.
Status | Recruiting |
Enrollment | 600 |
Est. completion date | July 31, 2023 |
Est. primary completion date | July 31, 2023 |
Accepts healthy volunteers | Accepts Healthy Volunteers |
Gender | All |
Age group | 9 Years to 45 Years |
Eligibility | Inclusion Criteria: 1. Patients with narcolepsy , Kleine-Levin syndrome(KLS) or Idiopathic Hypersomnia (IH) diagnosed by a physician who meet the ICSD-3 diagnostic criteria 2. Age: 9-45 years old 3. Those who agree to participate in this research and can sign the consent form. Exclusion Criteria: 1. Patients with epilepsy, head trauma and severe organic brain disease. 2. Patients with severe Obstructive Sleep Apnea (OSA) and severe Periodic Limb Movement Disorder (PLMD) who have not received treatment. 3. People with narcolepsy due to other physical and brain diseases. 4. Those who cannot cooperate with the brain imaging examination and neurocognitive function test. 5. Exclude those who have had brain surgery for brain tumor hemangioma, or those who have cerebral blood vessel metal clips. 6. Exclude current pacemakers. 7. Excluded those who had implanted artificial heart metal valve. 8. Those who underwent surgery within the last 3 months were excluded. 9. rule out claustrophobia 10. Those who are unwilling to participate in this research or are unwilling to fill in the consent form. |
Country | Name | City | State |
---|---|---|---|
Taiwan | Chang Gung Memorial Hospital | Taoyuan | |
Taiwan | Chang Gung Memorial Hospital, Linkou | Taoyuan City |
Lead Sponsor | Collaborator |
---|---|
Chang Gung Memorial Hospital |
Taiwan,
Abe K. Lithium prophylaxis of periodic hypersomnia. Br J Psychiatry. 1977 Mar;130:312-3. — View Citation
Ali M, Auger RR, Slocumb NL, Morgenthaler TI. Idiopathic hypersomnia: clinical features and response to treatment. J Clin Sleep Med. 2009 Dec 15;5(6):562-8. — View Citation
Anderson KN, Pilsworth S, Sharples LD, Smith IE, Shneerson JM. Idiopathic hypersomnia: a study of 77 cases. Sleep. 2007 Oct;30(10):1274-81. — View Citation
Arnulf I, Rico TJ, Mignot E. Diagnosis, disease course, and management of patients with Kleine-Levin syndrome. Lancet Neurol. 2012 Oct;11(10):918-28. doi: 10.1016/S1474-4422(12)70187-4. Review. — View Citation
Bassetti C, Aldrich MS. Idiopathic hypersomnia. A series of 42 patients. Brain. 1997 Aug;120 ( Pt 8):1423-35. — View Citation
Brankack J, Kukushka VI, Vyssotski AL, Draguhn A. EEG gamma frequency and sleep-wake scoring in mice: comparing two types of supervised classifiers. Brain Res. 2010 Mar 31;1322:59-71. doi: 10.1016/j.brainres.2010.01.069. Epub 2010 Feb 1. — View Citation
CRITCHLEY M. Periodic hypersomnia and megaphagia in adolescent males. Brain. 1962 Dec;85:627-56. — View Citation
Engström M, Hallböök T, Szakacs A, Karlsson T, Landtblom AM. Functional magnetic resonance imaging in narcolepsy and the kleine-levin syndrome. Front Neurol. 2014 Jun 25;5:105. doi: 10.3389/fneur.2014.00105. eCollection 2014. Review. — View Citation
Fraiwan L, Lweesy K, Khasawneh N, Wenz H, Dickhaus H. Automated sleep stage identification system based on time-frequency analysis of a single EEG channel and random forest classifier. Comput Methods Programs Biomed. 2012 Oct;108(1):10-9. doi: 10.1016/j.c — View Citation
Frenette E, Kushida CA. Primary hypersomnias of central origin. Semin Neurol. 2009 Sep;29(4):354-67. doi: 10.1055/s-0029-1237114. Epub 2009 Sep 9. Review. — View Citation
Grimaldi D, Pierangeli G, Barletta G, Terlizzi R, Plazzi G, Cevoli S, Franceschini C, Montagna P, Cortelli P. Spectral analysis of heart rate variability reveals an enhanced sympathetic activity in narcolepsy with cataplexy. Clin Neurophysiol. 2010 Jul;12 — View Citation
Grosse-Wentrup M, Liefhold C, Gramann K, Buss M. Beamforming in noninvasive brain-computer interfaces. IEEE Trans Biomed Eng. 2009 Apr;56(4):1209-19. doi: 10.1109/TBME.2008.2009768. — View Citation
Guilleminault C, Lopes MC, Hagen CC, da Rosa A. The cyclic alternating pattern demonstrates increased sleep instability and correlates with fatigue and sleepiness in adults with upper airway resistance syndrome. Sleep. 2007 May;30(5):641-7. — View Citation
Hadjiyannakis K, Ogilvie RD, Alloway CE, Shapiro C. FFT analysis of EEG during stage 2-to-REM transitions in narcoleptic patients and normal sleepers. Electroencephalogr Clin Neurophysiol. 1997 Nov;103(5):543-53. — View Citation
Jaussent I, Morin CM, Ivers H, Dauvilliers Y. Incidence, worsening and risk factors of daytime sleepiness in a population-based 5-year longitudinal study. Sci Rep. 2017 May 2;7(1):1372. doi: 10.1038/s41598-017-01547-0. — View Citation
Kanbayashi T, Kodama T, Kondo H, Satoh S, Inoue Y, Chiba S, Shimizu T, Nishino S. CSF histamine contents in narcolepsy, idiopathic hypersomnia and obstructive sleep apnea syndrome. Sleep. 2009 Feb;32(2):181-7. — View Citation
Pike M, Stores G. Kleine-Levin syndrome: a cause of diagnostic confusion. Arch Dis Child. 1994 Oct;71(4):355-7. — View Citation
* Note: There are 17 references in all — Click here to view all references
Type | Measure | Description | Time frame | Safety issue |
---|---|---|---|---|
Primary | Polysomnography (PSG) | Change in sleep latency (SL, mins) based on PSG during the study. | Once a year until the study is completed (up to 3 years) | |
Primary | Multiple sleep latency test (MSLT) | Change in Change in sleep latency (SL, mins) based on MSLT during the study. | Once a year until the study is completed (up to 3 years) | |
Primary | HLA TYPING | The investigators will use sequence-specific primer - polymerase chain reaction (SSP-PCR) to detect HLA-DQB1 and reverse sequence-specific oligonucleotide probes (SSOPs) to detect HLA-DQA1,and also use Sequencing Based Typing (SBT) and reverse sequence specific oligonucleotide (rSSO) to detect HLA-DRB and HLA-DQB in the lab. | baseline | |
Primary | Actigraphy | Change in sleep latency (mins) based on actigraphy during the study. | Once a year until the study is completed (up to 3 years) | |
Primary | PET/MRI | Positron Emission Tomography is a fusion of PET and MRI imaging techniques that can show the spread of diseased cells in soft tissue. The PET/MRI system can scan various parts of the patient and collect PET and MRI images separately for early diagnosis. | through study completion, an average of 1 year | |
Secondary | Conners' Continuous Performance Test (CPT) | The Conners Continuous Performance Test is a computer administered test that is designed to assess problems with attention.Many statistics are computed including omission errors , commission errors, hit reaction time, hit reaction time standard error, detectability, response style, perseverations , hit reaction time by block, standard error by block, reaction time by ISI , and standard error by ISI. These statistics are converted to T-scores and can be interpreted in terms of various aspects of attention including inattention, impulsivity, and vigilance.Higher rates of correct detections indicate better attentional capacity. | Once a year until the study is completed (up to 3 years) | |
Secondary | Wisconsin Card Sorting Test (WCST) | The Wisconsin Card Sorting Test (WCST) is a neuropsychological test that is frequently used to measure such higher-level cognitive processes as attention, perseverance,working memory, abstract thinking and set shifting. | Once a year until the study is completed (up to 3 years) | |
Secondary | Epworth Sleepoiness Scale (ESS) | Epworth Sleepoiness Scale (ESS) assesses the responder's propensity to doze or fall asleep during 8 common daily activities, such as: sitting and reading; sitting inactive in a public place; sitting and talking to someone; sitting quietly after a lunch without alcohol; or in a car, while stopped for a few minutes in traffic. An ESS score >10 suggests excessive daytime sleepiness (EDS); ESS score =16 suggests a high level of EDS. | Once a year until the study is completed (up to 3 years) | |
Secondary | Pediatric Daytime Sleepiness Scale (PDSS) | The pediatric daytime sleepiness questionnaire is a 5 points Likert scale (0-4) for 8 questions concerning to sleepiness. Scores ranged from 0 to 32.Higher scores on PDSS were associated with reduced total sleep time, poorer school achievement, poorer anger control, and frequent illness. | Once a year until the study is completed (up to 3 years) | |
Secondary | Short Form-36 (SF-36) | 36-Item Short-Form Health Survey (SF-36) includes 11 major questions that evaluate eight components (0-100), with higher scores indicating better outcome.These components include physical functioning, role limitations due to physical health, role limitations due to emotional problems, energy/fatigue, emotional wellbeing, social functioning, pain, and general health. | Once a year until the study is completed (up to 3 years) | |
Secondary | Polysomnography (PSG)-SE | Change in sleep efficiency (SE, %)based on PSG during the study. | Once a year until the study is completed (up to 3 years) | |
Secondary | Polysomnography (PSG)-TST | Change in total sleep time (TST, mins) based on PSG during the study. | Once a year until the study is completed (up to 3 years) | |
Secondary | Polysomnography (PSG)-WASO | Change in slow wave sleep (SWS, %) based on PSG during the study. | Once a year until the study is completed (up to 3 years) | |
Secondary | Polysomnography (PSG)-REM | Change in REM sleep (%) based on PSG during the study. | Once a year until the study is completed (up to 3 years) | |
Secondary | Polysomnography (PSG)-SWS | Change in slow wave sleep (SWS, %) based on PSG during the study. | Once a year until the study is completed (up to 3 years) | |
Secondary | Actigraphy-TST | Total sleep time (TST, mins) based on actigraphy during the study. | Once a year until the study is completed (up to 3 years) | |
Secondary | Actigraphy-SE | Sleep efficiency (SE, %) based on actigraphy during the study. | Once a year until the study is completed (up to 3 years) | |
Secondary | Actigraphy-WASO | Wake after sleep onset (WASO) based on actigraphy during the study. | Once a year until the study is completed (up to 3 years) |
Status | Clinical Trial | Phase | |
---|---|---|---|
Not yet recruiting |
NCT05983731 -
A Pilot Observational Study to Assess the Ability of Continuous 'Home' EEG to Accurately Diagnose Narcolepsy and Demonstrate Response to Treatment
|
||
Withdrawn |
NCT03626727 -
Evaluation of the Efficacy of Sodium Oxybate (Xyrem®) in Treatment of Post-traumatic Narcolepsy and Post-traumatic Hypersomnia
|
Early Phase 1 | |
Completed |
NCT01183312 -
Flumazenil for the Treatment of Primary Hypersomnia
|
Phase 1/Phase 2 | |
Terminated |
NCT03198156 -
Transcranial Direct Current Stimulation Therapy for Central Hypersomnia Without Cataplexy
|
N/A | |
Completed |
NCT03682185 -
The Healthy Patterns Sleep Study
|
Phase 3 | |
Completed |
NCT00916253 -
Method of Assessment of Driving Ability in Patients Suffering From Wakefulness Pathologies
|
N/A | |
Completed |
NCT04157244 -
The Music, Sleep and Dementia Study
|
N/A | |
Completed |
NCT01877616 -
Sleep Disorders and Their Cardiovascular Correlates in Atahualpa.
|
N/A | |
Suspended |
NCT00427323 -
Light Exposure to Treat Sleep Disruption in Older People
|
N/A | |
Not yet recruiting |
NCT04300166 -
Telemedicine and Humidification for Cpap IN Osas Key Treatment (THINK Study)
|
N/A | |
Not yet recruiting |
NCT06404086 -
RECOVER-SLEEP: Platform Protocol
|
Phase 2 | |
Not yet recruiting |
NCT06404099 -
RECOVER-SLEEP: Platform Protocol, Appendix_A (Hypersomnia)
|
Phase 2 | |
Completed |
NCT01146600 -
Clarithromycin for the Treatment of Hypersomnia
|
Phase 2 | |
Withdrawn |
NCT05627388 -
Feasibility Study of At-Home EEG Monitoring for Hypersomnia
|
N/A | |
Completed |
NCT01764035 -
Mindfulness Therapy on Disrupted Sleep in Bipolar Disorder
|
N/A | |
Completed |
NCT03459300 -
Importance of Sleep Deprivation in Differential Diagnosis of Primary Hypersomnia (Actisom dépistage)
|
||
Completed |
NCT00001664 -
Sleep Disorders of Patients With Diseases of the Nervous System
|
N/A | |
Recruiting |
NCT04201392 -
Sleep in Psychiatric Inpatients
|
||
Suspended |
NCT05230394 -
Patient Outcomes in Unattended and In- Lab Polysomnography
|
N/A | |
Terminated |
NCT01544465 -
Structured Physical Activity for Sleep Quality and Daytime Sleepiness in Patients With Parkinson's Disease
|
N/A |