N/A
N=92
Improving Sleep Using Mentored Behavioral and Environmental Restructuring
Insomnia
Bottom Line
View on ClinicalTrials.gov: NCT03327324 ↗Enrolled (actual)
92
Serious AEs
0.0%
Results posted
Feb 2023
Primary outcome: Primary: Sleep Efficiency (SE) — 76.1 percentage of time in bed
Study Design & Population
- Study type
- Interventional
- Phase
- N/A
- Interventions
- Sleep Using Mentored Behavioral and Environmental Restructuring (Behavioral)
- Age
- Adult, Older Adult · 18+ yrs
- Sex
- All
- Sponsor
- NYU Langone Health
- Primary completion
- Feb 2021
Outcome Measures
| Outcome | Result | p-value |
|---|---|---|
| PRIMARY Sleep Efficiency (SE) |
75.61 | — |
| PRIMARY Sleep Efficiency (SE) |
75.61 | — |
| PRIMARY Sleep Efficiency (SE) |
75.61 | — |
| PRIMARY Nighttime Total Awake Time |
11.8 | — |
| PRIMARY Nighttime Total Awake Time |
11.8 | — |
| PRIMARY Nighttime Total Awake Time |
11.8 | — |
| PRIMARY Daytime Sleeping (Napping) Time |
338.26 | — |
| PRIMARY Daytime Sleeping (Napping) Time |
338.26 | — |
| PRIMARY Daytime Sleeping (Napping) Time |
338.26 | — |
| PRIMARY Score on Pittsburgh Sleep Quality Index (PSQI) |
6.5 | — |
| PRIMARY Brief Anxiety and Depression Scale (BADS) Questionnaire Score |
5.15 | — |
| PRIMARY Score on Brief Cognitive Assessment Tool (BCAT) |
28.33 | — |
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.
Eligibility Criteria
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.
Data sourced from ClinicalTrials.gov (NCT03327324). Outcome figures and adverse-event rates are extracted automatically from the registry's posted results and are provided for clinician reference, not as a substitute for the primary publication.