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Completed

NCT Number: NCT03327324

Improving Sleep Using Mentored Behavioral and Environmental Restructuring

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.

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Key information

Conditions

Insomnia Dyssomnias Mental Disorders Nervous System Diseases Sleep Disorders, Intrinsic Sleep Initiation and Maintenance Disorders Sleep Wake Disorders

Age range

18 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

New York University School of Medicine

New York, 10016, United States

About this study

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

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

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.

Treatment and study plan

Sleep Using Mentored Behavioral and Environmental Restructuring

Behavioral

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.

Other names: SLUMBER

Primary outcomes

  1. Sleep Efficiency (SE)

    Time frame: Baseline

    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.

  2. Sleep Efficiency (SE)

    Time frame: Post-Treatment (Month 6 Post-Baseline)

    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.

  3. Sleep Efficiency (SE)

    Time frame: Month 9 Post-Baseline

    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.

  4. Nighttime Total Awake Time

    Time frame: Baseline

    Data will be obtained from antigraphy analysis.

  5. Nighttime Total Awake Time

    Time frame: Post-Treatment (Month 6 Post-Baseline)

    Data will be obtained from antigraphy analysis.

  6. Nighttime Total Awake Time

    Time frame: Month 9 Post-Baseline

    Data will be obtained from antigraphy analysis.

  7. Daytime Sleeping (Napping) Time

    Time frame: Baseline

    Wrist device / actigraphy will be used to measure sleep/wake time.

  8. Daytime Sleeping (Napping) Time

    Time frame: Post-Treatment (Month 6 Post-Baseline)

    Wrist device / actigraphy will be used to measure sleep/wake time.

  9. Daytime Sleeping (Napping) Time

    Time frame: Month 9 Post-Baseline

    Wrist device / actigraphy will be used to measure sleep/wake time.

  10. Score on Pittsburgh Sleep Quality Index (PSQI)

    Time frame: Month 9 Post-Baseline

    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.

  11. Brief Anxiety and Depression Scale (BADS) Questionnaire Score

    Time frame: Month 9 Post-Baseline

    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

  12. Score on Brief Cognitive Assessment Tool (BCAT)

    Time frame: Month 9 Post-Baseline

    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.

Sponsors and collaborators

Lead sponsor

NYU Langone Health

Other

Collaborators

  • National Institute of Nursing Research (NINR)
  • National Institutes of Health (NIH)

Registry information

Acronym: SLUMBER

Important dates

Study start
2018
Primary completion
2021
Study completion
2021
First posted
Oct 31, 2017
Registry last updated
Feb 8, 2023

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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