A Multicomponent Intervention for Prevention and Treatment of Sleep Disturbances in a Psychiatric Intensive Care Unit

Dyssomnias Clinical Trial

— SUEÑA-SM  

Official title:

A Multicomponent Intervention for Prevention and Treatment of Sleep Disturbances in a Psychiatric Intensive Care Unit: A Before-After, Randomized, Controlled Trial

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT04995263
• Other study ID #: 0
• Status: Recruiting
• Phase: N/A
• Start date: June 22, 2021
• Est. completion date: August 1, 2023

Study information

• Verified date: September 2022
• Source: Pontificia Universidad Catolica de Chile
• Contact: Constanza Caneo Robles, MD
• Phone: +56 9 4290 9250
• Email: cmcaneo[@]uc.cl
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial Summary

Hospitalized adult patients suffer from sleep deprivation, which has been associated with multiple negative consequences, both in short and in the long term. Many factors have been attributed to poor sleep quality, including excessive noise, inappropriate lighting, interactions with the healthcare team, administration of drugs, patients' symptoms, among others. There is scarce evidence reporting multicomponent interventions aimed at ensuring and improving sleep quality in hospitalized patients. The following before-after, randomized controlled trial will evaluate and determine the feasibility, acceptability and effectivity of a multicomponent intervention in improving sleep quality and reducing the consequences of poor sleep in a psychiatric intensive care unit (PICU). The intervention is comprised of changes in health personnel habits, improvements in the PICU environment, patient's psychoeducation and continuous sleep and activity monitoring through a validated wearable device.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 120
• Est. completion date: August 1, 2023
• Est. primary completion date: December 1, 2022
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

Inclusion Criteria:

• Hospitalized in the last 72 hours.

• Capacity to consent

• Approval by treating physician

Exclusion Criteria:

• Active psychosis

• Active eating disorder

• Delirium

• Major cognitive disorder

Related Conditions & MeSH terms

• Dyssomnias
• Parasomnias

Intervention

Behavioral:
• Sueña component 1: Sleep Hygiene Promotion
The nursery staff will be instructed to promote sleep hygiene. Nurse technicians will: inform patients of the efforts to ensure a healthy sleep environment, verify the minimization of light and noise after 23:00 PM, favour natural light after 07:00 AM, and foment patient's activities and participation in group therapy. Nurses will: reduce sleep interruptions to a minimum, to only perform actions (i.e. blood testing, clinical controls, medicine administration) deemed strictly necessary between 23:00 PM and 07:00 AM. A list of commonly used medications with their pharmacodynamic and pharmacokinetic properties tailored by a pharmaceutical chemist will be provided, to ensure optimal medication administration while protecting the guaranteed sleep hours, to be coordinated with the treating physician.
• Sueña component 2: Periodic Anxiety and Pain Screening
Every night, nursery staff will include anxiety and pain screenings as part of vital signs assessments, using visual analog scales for each one. If any screening is altered, clinical actions will be performed to alleviate symptomatology if deemed necessary, using clinical judgement.
• Sueña component 3: Hypnotics and Caffeine Regulation
The use of hypnotics will be standardized to be administered no later than at 22:00 PM; in the case of melatonin, its administration will be suggested at sundown, at 20:00 PM. Caffeinated drinks will be prohibited after 15:00 PM.
• Sueña component 4: Sleep Masks and Ear Plugs
Sleep masks and ear plugs will be available to all patients if they wish to use them. The nursery team will reinforce its use between 23:00 PM and 07:00 AM.

Other:
• Sueña component 5: Personalized Psychoeducation
Two individualized, nurse-led psychoeducation PowerPoint presentations on sleep hygiene will be presented to patients, supported by educational material aimed at the patient and their families.

Device:
• Sueña component 6: Sleep Reports
Objective and subjective reports of sleep quality will be handed to attending psychiatrist, using data gathered with wearable devices (Fitbit Charge 4) and self-report questionnaires regarding perceived sleepiness and overall sleep. The psychiatrist in charge uses said information in the routine case management

Locations

Country	Name	City	State
Chile	Clínica San Carlos de Apoquindo UC	Santiago de Chile	Región Metropolitana

Sponsors (2)

Lead Sponsor	Collaborator
Pontificia Universidad Catolica de Chile	UC CHRISTUS

Country where clinical trial is conducted

Chile, 

References & Publications (18)

Bano M, Chiaromanni F, Corrias M, Turco M, De Rui M, Amodio P, Merkel C, Gatta A, Mazzotta G, Costa R, Montagnese S. The influence of environmental factors on sleep quality in hospitalized medical patients. Front Neurol. 2014 Dec 11;5:267. doi: 10.3389/fneur.2014.00267. eCollection 2014. — View Citation

Bernhofer EI, Higgins PA, Daly BJ, Burant CJ, Hornick TR. Hospital lighting and its association with sleep, mood and pain in medical inpatients. J Adv Nurs. 2014 May;70(5):1164-73. doi: 10.1111/jan.12282. Epub 2013 Oct 27. — View Citation

Bourne RS, Mills GH. Sleep disruption in critically ill patients--pharmacological considerations. Anaesthesia. 2004 Apr;59(4):374-84. Review. — View Citation

Denkinger MD, Lindemann U, Nicolai S, Igl W, Jamour M, Nikolaus T. Assessing Physical Activity in Inpatient Rehabilitation: validity, practicality, and sensitivity to change in the physical activity in inpatient rehabilitation assessment. Arch Phys Med Rehabil. 2011 Dec;92(12):2012-7. doi: 10.1016/j.apmr.2011.06.032. — View Citation

Horne S, Hay K, Watson S, Anderson KN. An evaluation of sleep disturbance on in-patient psychiatric units in the UK. BJPsych Bull. 2018 Oct;42(5):193-197. doi: 10.1192/bjb.2018.42. — View Citation

Hu RF, Jiang XY, Chen J, Zeng Z, Chen XY, Li Y, Huining X, Evans DJ. Non-pharmacological interventions for sleep promotion in the intensive care unit. Cochrane Database Syst Rev. 2015 Oct 6;(10):CD008808. doi: 10.1002/14651858.CD008808.pub2. Review. — View Citation

Kanji S, Mera A, Hutton B, Burry L, Rosenberg E, MacDonald E, Luks V. Pharmacological interventions to improve sleep in hospitalised adults: a systematic review. BMJ Open. 2016 Jul 29;6(7):e012108. doi: 10.1136/bmjopen-2016-012108. Review. — View Citation

Lawrence G, Muza R. Assessing the sleeping habits of patients in a sleep disorder centre: a review of sleep diary accuracy. J Thorac Dis. 2018 Jan;10(Suppl 1):S177-S183. doi: 10.21037/jtd.2017.12.127. — View Citation

Milani RV, Bober RM, Lavie CJ, Wilt JK, Milani AR, White CJ. Reducing Hospital Toxicity: Impact on Patient Outcomes. Am J Med. 2018 Aug;131(8):961-966. doi: 10.1016/j.amjmed.2018.04.013. Epub 2018 May 3. — View Citation

Novak C, Packer E, Paterson A, Roshi A, Locke R, Keown P, Watson S, Anderson KN. Feasibility and utility of enhanced sleep management on in-patient psychiatry wards. BJPsych Bull. 2020 Dec;44(6):255-260. doi: 10.1192/bjb.2020.30. — View Citation

Pilkington S. Causes and consequences of sleep deprivation in hospitalised patients. Nurs Stand. 2013 Aug 7-13;27(49):35-42. Review. — View Citation

Rodriguez JC, Dzierzewski JM, Alessi CA. Sleep problems in the elderly. Med Clin North Am. 2015 Mar;99(2):431-9. doi: 10.1016/j.mcna.2014.11.013. Epub 2014 Dec 30. Review. — View Citation

Sandoval-Rincón M, Alcalá-Lozano R, Herrera-Jiménez I, Jiménez-Genchi A. [Validation of the Epworth sleepiness scale in Mexican population]. Gac Med Mex. 2013 Jul-Aug;149(4):409-16. Spanish. — View Citation

Stewart NH, Arora VM. Sleep in Hospitalized Older Adults. Sleep Med Clin. 2018 Mar;13(1):127-135. doi: 10.1016/j.jsmc.2017.09.012. Epub 2017 Nov 10. Review. — View Citation

Tamrat R, Huynh-Le MP, Goyal M. Non-pharmacologic interventions to improve the sleep of hospitalized patients: a systematic review. J Gen Intern Med. 2014 May;29(5):788-95. doi: 10.1007/s11606-013-2640-9. Epub 2013 Oct 10. Review. — View Citation

Tembo AC, Parker V. Factors that impact on sleep in intensive care patients. Intensive Crit Care Nurs. 2009 Dec;25(6):314-22. doi: 10.1016/j.iccn.2009.07.002. Epub 2009 Oct 31. Review. — View Citation

Tullmann DF, Dracup K. Creating a healing environment for elders. AACN Clin Issues. 2000 Feb;11(1):34-50; quiz 153-4. Review. — View Citation

Wesselius HM, van den Ende ES, Alsma J, Ter Maaten JC, Schuit SCE, Stassen PM, de Vries OJ, Kaasjager KHAH, Haak HR, van Doormaal FF, Hoogerwerf JJ, Terwee CB, van de Ven PM, Bosch FH, van Someren EJW, Nanayakkara PWB; "Onderzoeks Consortium Acute Geneeskunde" Acute Medicine Research Consortium. Quality and Quantity of Sleep and Factors Associated With Sleep Disturbance in Hospitalized Patients. JAMA Intern Med. 2018 Sep 1;178(9):1201-1208. doi: 10.1001/jamainternmed.2018.2669. — View Citation

* Note: There are 18 references in all — Click here to view all references

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Change in Total Sleep Time	Measured in hours and minutes, using objective data obtained via Fitbit Charge 4 devices, and subjective data obtained directly from the patient using the Sleep Diary, a consensus tool for the self report of different standardized sleep variables.	From enrollment, during the first 72 hours of hospitalization, for up to 14 days or discharge.
Secondary	Change in Mean Number and Total Duration of Nocturnal Awakenings	Measured in integer numbers for mean number and minutes for duration, using subjective data obtained directly from the patient using the Sleep Diary, and objective data obtained via Fitbit Charge 4 devices.	From enrollment, during the first 72 hours of hospitalization, for up to 14 days or discharge.
Secondary	Change in Mean Number and Total Duration of Naps During the Day	Measured in integer numbers for mean number and minutes for duration, using subjective data obtained directly from the patient using the Sleep Diary, and objective data obtained via Fitbit Charge 4 devices.	From enrollment, during the first 72 hours of hospitalization, for up to 14 days or discharge.
Secondary	Change in Average Time of Falling Sleep and Awakening	Measured in time of day in 24-hour notation, using subjective data obtained directly from the patient using the Sleep Diary, and objective data obtained via Fitbit Charge 4 devices.	From enrollment, during the first 72 hours of hospitalization, for up to 14 days or discharge.
Secondary	Change in Sleep Architecture	Measured in minutes of total duration for each sleep phase (awake, light sleep, deep sleep and REM) and as a relative value of the total sleep time, using objective data measured by Fitbit Charge 4 devices.	From enrollment, during the first 72 hours of hospitalization, for up to 14 days or discharge.
Secondary	Change in Sleep Onset Latency Mean Duration	Measured in minutes of total time spent awake from the time of going to bed with the intention of falling asleep to the time of the first registered sleep phase, using subjective data from the Sleep Diary and objective data measured by Fitbit Charge 4 devices.	From enrollment, during the first 72 hours of hospitalization, for up to 14 days or discharge.
Secondary	Change in REM Onset Latency Mean Duration	Measured in minutes of total time spent awake from the time of going to bed with the intention of falling asleep to the time of the first registered REM phase, using subjective data from the Sleep Diary and objective data measured by Fitbit Charge 4 devices.	From enrollment, during the first 72 hours of hospitalization, for up to 14 days or discharge.
Secondary	Change in Wake After Sleep Onset Mean Duration	Measured in minutes of total time spent awake from the time of the first registered sleep phase to the time of the last registered awakening, using objective data measured by Fitbit Charge 4 devices.	From enrollment, during the first 72 hours of hospitalization, for up to 14 days or discharge.
Secondary	Change in Sleep Efficiency	Measured in percentage of total time spent sleeping at night, calculated as total sleep time divided by total time spent in bed, using subjective data from the Sleep Diary and objective data measured by Fitbit Charge 4 devices.	From enrollment, during the first 72 hours of hospitalization, for up to 14 days or discharge.
Secondary	Change in Mean Heart Rate	Measured in integer numbers, using objective data measured by Fitbit Charge 4 devices, considering the heart rate during the day and while in bed.	From enrollment, during the first 72 hours of hospitalization, for up to 14 days or discharge.
Secondary	Change in Mean Number of Steps	Measured in integer numbers, using objective data measured by Fitbit Charge 4 devices.	From enrollment, during the first 72 hours of hospitalization, for up to 14 days or discharge.
Secondary	Change in Mean Level of Sound	Measured in decibels, using objective data registered by a decibel meter placed in the participant's rooms.	From enrollment, during the first 72 hours of hospitalization, for up to 14 days or discharge.
Secondary	Change in Mean Level of Light	Measured in lux, using objective data registered by a lux meter placed in the participant's rooms.	From enrollment, during the first 72 hours of hospitalization, for up to 14 days or discharge.
Secondary	Changes in Sleep Quality Perception	Measured using the Richard Campbell Sleep Questionnaire (RCSQ), which considers 5 domains in Likert scales, and registers a mean score of all domains.	From enrollment, during the first 72 hours of hospitalization, for up to 14 days or discharge.
Secondary	Changes in Daytime Sleepiness	Measured using the Epworth Sleepiness Scale (ESS), which considers 8 hypothetical situations and scores the likelihood of falling asleep from 0 to 3, and registers a total aggregated score (with a maximum total score of 24).	From enrollment, during the first 72 hours of hospitalization, for up to 14 days or discharge.
Secondary	Changes in Subjective Perception of Sleep-Disturbing Factors	Measured using complementary questions regarding the presence/absence of factors (either environmental, symptomatological, or other) and their identification using predefined options: excessive light, excessive noise, interactions with health personnel, pain, anxiety, or others. In case of selecting "others", a text field will be available for its description.	From enrollment, during the first 72 hours of hospitalization, for up to 14 days or discharge.
Secondary	Changes in Pharmacological Indications and Need of SOS Medication	Registered using extensive charts of common use medications during hospitalization, obtaining data registered in the participant's daily medical chart.	From enrollment, during the first 72 hours of hospitalization, for up to 14 days or discharge.
Secondary	Changes in Systolic and Diastolic Blood Pressure	Measured in millimetres of mercury (mmHg), using morning data registered in the participant's daily medical chart.	From enrollment, during the first 72 hours of hospitalization, for up to 14 days or discharge.
Secondary	Level of Pain	Measured with a Visual Analog Scale for Pain (scores ranging from 0 - 10 points), using data registered at 20:00 PM, in the participant's daily medical chart.	From enrollment, during the first 72 hours of hospitalization, for up to 14 days or discharge. To be measured from the second branch onward, after the environmental interventions implementation.
Secondary	Level of Anxiety	Measured with a Visual Analog Scale for Anxiety (scores ranging from 0 - 10 points), using data registered at 20:00 PM, in the participant's daily medical chart.	From enrollment, during the first 72 hours of hospitalization, for up to 14 days or discharge. To be measured from the second branch onward, after the environmental interventions implementation.
Secondary	Change in Mean Length of Stay	Measured in days, using data from the participant's medical record.	From day 1 of hospitalization until discharge
Secondary	Change in 30-day Readmission Rate	Measured as a proportion, using data from the participant's medical record and telephonic follow-up.	30 days after the participant's discharge.
Secondary	Change in Participant Satisfaction Regarding Sleep During Hospitalization	Measurement of the subjective experience of the participant, using telephone surveys.	7 days after the participant's discharge.
Secondary	Participant Satisfaction Regarding the Intervention	Measurement of the subjective experience of participants, using telephone surveys.	7 days after the participant's discharge.
Secondary	Health Personnel Satisfaction and Agreeability Regarding the Intervention	Measurement of the subjective experience of treating physicians and nursery team, using web-based surveys.	Every 3 months through study completion, an average of 1.5 years