A Multicomponent Intervention for Prevention and Treatment of Sleep Disturbances in a Psychiatric Intensive Care Unit (SUEÑA-SM)

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

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.

Study Overview

• Status: Recruiting
• Conditions: Dyssomnias
• Intervention / Treatment: Behavioral: Sueña component 1: Sleep Hygiene Promotion; Behavioral: Sueña component 2: Periodic Anxiety and Pain Screening; Behavioral: Sueña component 3: Hypnotics and Caffeine Regulation; Behavioral: Sueña component 4: Sleep Masks and Ear Plugs; Other: Sueña component 5: Personalized Psychoeducation; Device: Sueña component 6: Sleep Reports

• Study Type: Interventional
• Enrollment (Anticipated): 120
• Phase: Not Applicable

Contacts and Locations

• Study Contact: Name: Constanza Caneo Robles, MD; Phone Number: +56 9 4290 9250; Email: cmcaneo@uc.cl
• Study Contact Backup: Name: Juan C Rodríguez, MD; Phone Number: +56 9 4448 9732; Email: jcrtjcrt@gmail.com

Study Locations

• Chile
  • Región Metropolitana
    • Santiago de Chile, Región Metropolitana, Chile, 7550000
      • Recruiting
      • Clínica San Carlos de Apoquindo UC
      • Sub-Investigator: Pedro Letelier Camus, MD
      • Sub-Investigator: Simón Medina, MD
      • Sub-Investigator: Matías Paredes Gálvez, BE

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years and older (Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

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

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Prevention
• Allocation: Randomized
• Interventional Model: Sequential Assignment
• Masking: Single

Number of Arms

4

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
No Intervention: Pre-intervention, control group; A basal measurement of primary and secondary outcomes of the target population, prior to the implementation the intervention. Estimated duration 3 months, n = 30.
Experimental: Post-intervention, SUEÑA half bundle, active group 1; Post-intervention, environmental and behavioral modifications in patient care interventions. Implementation of components 1 through 4 of SUEÑA intervention in the entire PICU unit. All participants will be exposed to the intervention. Estimated duration: 3 months, n = 30.	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.; Behavioral: 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.; Behavioral: 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.; Behavioral: 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.
Experimental: Post-intervention, randomization for SUEÑA half bundle plus, active group 2; Randomization for full SUEÑA bundle: environmental and behavioral modifications in patient care interventions plus sleep informed treatment. Participants will be randomized to receive SUEÑA components 1 through 5 Estimated duration: 6 months, n = 30	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.; Behavioral: 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.; Behavioral: 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.; Behavioral: 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.
Experimental: Post-intervention, randomization for SUEÑA full bundle, active group 3; Randomization for full SUEÑA bundle: environmental and behavioral modifications in patient care interventions plus sleep informed treatment and personalized psychoeducation. . Participants will be randomized to receive SUEÑA components 1 through 6. Estimated duration: 6 months, n = 30	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.; Behavioral: 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.; Behavioral: 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.; Behavioral: 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

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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 Outcome Measures

Outcome Measure	Measure Description	Time Frame
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.
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.
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.
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.
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.
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.
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.
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.
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.
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.
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.
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.
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.
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.
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.
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.
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.
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.
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.
Change in Mean Length of Stay	Measured in days, using data from the participant's medical record.	From day 1 of hospitalization until discharge
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.
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.
Participant Satisfaction Regarding the Intervention	Measurement of the subjective experience of participants, using telephone surveys.	7 days after the participant's discharge.
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

Collaborators and Investigators

• Sponsor: Pontificia Universidad Catolica de Chile
• Collaborators: UC CHRISTUS
• Investigators: Study Director: Constanza Caneo Robles, MD, Pontifica Universidad Catolica de Chile; Study Director: Juan C Rodríguez, MD, Pontifica Universidad Catolica de Chile; Study Chair: María Rodríguez Fernández, PhD, Pontifica Universidad Catolica de Chile; Study Chair: Marcela Babul, MD, Pontifica Universidad Catolica de Chile

Publications and helpful links

General Publications

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• 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;2015(10):CD008808. doi: 10.1002/14651858.CD008808.pub2.
• 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.
• 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.
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• 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.
• 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.
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• Tullmann DF, Dracup K. Creating a healing environment for elders. AACN Clin Issues. 2000 Feb;11(1):34-50; quiz 153-4. Review.
• 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.
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Study record dates

Study Major Dates

• Study Start (Actual): June 22, 2021
• Primary Completion (Anticipated): December 1, 2022
• Study Completion (Anticipated): August 1, 2023

Study Registration Dates

• First Submitted: July 22, 2021
• First Submitted That Met QC Criteria: July 31, 2021
• First Posted (Actual): August 6, 2021

Study Record Updates

• Last Update Posted (Actual): September 30, 2022
• Last Update Submitted That Met QC Criteria: September 29, 2022
• Last Verified: September 1, 2022

More Information

Terms related to this study

• Keywords: Sleep; Behavioral Intervention; Psychoeducation; Psychiatric Intensive Care Unit; Multicomponent Intervention; Wearable Activity Tracker; Environmental Interventions
• Additional Relevant MeSH Terms: Mental Disorders; Nervous System Diseases; Sleep Wake Disorders; Dyssomnias; Parasomnias; Physiological Effects of Drugs; Neurotransmitter Agents; Molecular Mechanisms of Pharmacological Action; Central Nervous System Depressants; Enzyme Inhibitors; Purinergic Antagonists; Purinergic Agents; Phosphodiesterase Inhibitors; Purinergic P1 Receptor Antagonists; Central Nervous System Stimulants; Caffeine; Hypnotics and Sedatives
• Other Study ID Numbers: Institute of Psychiatry

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: Yes
• IPD Plan Description: We are available to be contacted by researchers aiming to conduct secondary analyses based on our study, after providing a study protocol based on international guidelines, in order to ensure adequate use of our data.
• IPD Sharing Time Frame: January 2024
• IPD Sharing Access Criteria: contact to responsable researcher C Caneo
• IPD Sharing Supporting Information Type: Study Protocol; Statistical Analysis Plan (SAP); Informed Consent Form (ICF); Clinical Study Report (CSR)

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No