Improving Sleep Using Mentored Behavioral and Environmental Restructuring

Insomnia Clinical Trial

— SLUMBER  

Official title:

Improving Sleep Using Mentored Behavioral and Environmental Restructuring

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT03327324
• Other study ID #: 17-00338
• Secondary ID: 1R01NR016461-01A
• Status: Completed
• Phase: N/A
• Start date: March 27, 2018
• Est. completion date: February 23, 2021

Study information

• Verified date: January 2023
• Source: NYU Langone Health
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial Summary

The goal of this study is to test potential functional/psychosocial benefits of improved sleep using a program designed to teach nursing facility staff to improve sleep promoting strategies and environment for nursing home residents. Sleep disturbances are quite common in skilled nursing facilities and affect as many as 69% of residents while staff do not fully understand how to improve sleep without using medications. Medications for sleep are commonly used as first-line therapy for older adults but this is problematic because these medications can lead to greater problems with thinking, more frequent falls, and even worse sleep over time. In addition, poor sleep can lead to depressed mood, greater trouble with thinking and memory, worse pain, and greater need for help with daily activities.

Description:

This is a study to test the effects of improved sleep quality on downstream functional/psychosocial outcomes.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 110
• Est. completion date: February 23, 2021
• Est. primary completion date: February 23, 2021
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: All
• Age group: 18 Years and older

Eligibility

Inclusion Criteria:

• living in the unit of intervention,

• ability to communicate and follow simple commands,

• English- or Spanish-speaking,

• capacity to consent assessed with standard questions used to assess capacity or having a surrogate who can provide consent.

Exclusion Criteria:

• Does not have capacity and does not show enthusiasm for the research

• Does not have capacity and does not have a proxy.

• obtunded or comatose state,

• inability to communicate verbally,

• inability to consent and without surrogate

• non-English and non-Spanish speaking. In keeping with QI strategies, all residents will be exposed to the environmental aspects of the intervention, as these strategies represent clinically proven non-experimental behavioral strategies with no perceptible harm.

Related Conditions & MeSH terms

• Insomnia

Intervention

Behavioral:
• Sleep Using Mentored Behavioral and Environmental Restructuring
SLUMBER is a non-pharmacological intervention program, delivered by providing mentoring to facility staff who work directly with residents. SLUMBER focuses on detecting sleep-disruptive factors including: nighttime noise and patient behaviors associated with poor sleep quality; disruptions caused by nighttime caregiving; daytime inactivity; and limited light exposure. In this model, staff-delivered interventions to improve these factors improve sleep quality thereby creating opportunities to test the impact of improving sleep quality (measured by actigraphy) on mood (depression and anxiety), pain, cognitive function, functional ability, and observed activity levels.

Locations

Country	Name	City	State
United States	New York University School of Medicine	New York	New York

Sponsors (3)

Lead Sponsor	Collaborator
NYU Langone Health	National Institute of Nursing Research (NINR), National Institutes of Health (NIH)

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Sleep Efficiency (SE)	Sleep efficiency (SE), commonly defined as the ratio of total sleep time (TST) to time in bed (TIB), will be reported as a percentage of time in bed. This data will be obtained from actigraphy analysis.	Baseline
Primary	Sleep Efficiency (SE)	Sleep efficiency (SE), commonly defined as the ratio of total sleep time (TST) to time in bed (TIB), will be reported as a percentage of time in bed. This data will be obtained from actigraphy analysis.	Post-Treatment (Month 6 Post-Baseline)
Primary	Sleep Efficiency (SE)	Sleep efficiency (SE), commonly defined as the ratio of total sleep time (TST) to time in bed (TIB), will be reported as a percentage of time in bed. This data will be obtained from actigraphy analysis.	Month 9 Post-Baseline
Primary	Nighttime Total Awake Time	Data will be obtained from antigraphy analysis.	Baseline
Primary	Nighttime Total Awake Time	Data will be obtained from antigraphy analysis.	Post-Treatment (Month 6 Post-Baseline)
Primary	Nighttime Total Awake Time	Data will be obtained from antigraphy analysis.	Month 9 Post-Baseline
Primary	Daytime Sleeping (Napping) Time	Wrist device / actigraphy will be used to measure sleep/wake time.	Baseline
Primary	Daytime Sleeping (Napping) Time	Wrist device / actigraphy will be used to measure sleep/wake time.	Post-Treatment (Month 6 Post-Baseline)
Primary	Daytime Sleeping (Napping) Time	Wrist device / actigraphy will be used to measure sleep/wake time.	Month 9 Post-Baseline
Primary	Score on Pittsburgh Sleep Quality Index (PSQI)	PSQI contains 19 self-rated questions. The 19 questions are combined to form seven "component" scores, each of which has a range of 0-3 points. In all cases, a score of "0" indicates no difficulty, while a score of "3" indicates severe difficulty. The total score range is 0-21; the higher the score, the greater the difficulties in all areas.	Month 9 Post-Baseline
Primary	Brief Anxiety and Depression Scale (BADS) Questionnaire Score	BADS is a brief screening tool for mood impairment developed for older adults. It consists of 8 questions, answered 0 (no), 1(somewhat), or 2 (yes). The total score range is 0-16; the higher the score, the higher the level of mood impairment	Month 9 Post-Baseline
Primary	Score on Brief Cognitive Assessment Tool (BCAT)	BCAT is a multi-domain cognitive instrument that assesses orientation, verbal recall, visual recognition, visual recall, attention, abstraction, language, executive functions, and visuo-spatial processing in adult and older adult populations. It consists of 21 items. The total score range is 0-50; the higher the score, the more normal the level of cognitive functioning and independent living.	Month 9 Post-Baseline