Clincosm LogoSign in Get a demo

SLUMBER: Improving Sleep Using Mentored Behavioral and Environmental Restructuring

Sponsor
NYU Langone Health (Other)
Overall Status
Completed
CT.gov ID
NCT03327324
Collaborator
National Institutes of Health (NIH) (NIH), National Institute of Nursing Research (NINR) (NIH)
110
Enrollment
1
Location
1
Arm
35
Actual Duration (Months)
3.1
Patients Per Site Per Month

Study Details

Study Description

Brief 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.

Condition or Disease Intervention/Treatment Phase
  • Diagnostic Test: Sleep Using Mentored Behavioral and Environmental Restructuring
 N/A

Detailed Description

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

Study Design

Study Type:
Interventional
Actual Enrollment :
110 participants
Allocation:
N/A
Intervention Model:
Single Group Assignment
Masking:
None (Open Label)
Primary Purpose:
Supportive Care
Official Title:
Improving Sleep Using Mentored Behavioral and Environmental Restructuring
Actual Study Start Date :
Mar 27, 2018
Actual Primary Completion Date :
Feb 23, 2021
Actual Study Completion Date :
Feb 23, 2021

Arms and Interventions

Arm Intervention/Treatment
Other: Resident of the Skilled Nursing Facility

Diagnostic Test: 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.
Other Names:
  • SLUMBER

    		•

    Outcome Measures

    Primary Outcome Measures

    1. Average Light Exposure [9 Months]

      wrist device / actigraphy will be used to measure light exposure.

    2. Average Sleep/Wake Time [9 Months]

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

    3. Score on Pittsburgh Sleep Quality Index (PSQI) [12 Months]

      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.

    4. Score on Brief Anxiety and Depression Scale (BADS) [12 Months]

      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 anxiety.

    5. Score on Brief Cognitive Assessment Tool (BCAT) [12 Months]

      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.

    Eligibility Criteria

    Criteria

    Ages Eligible for Study:
    18 Years and Older
    Sexes Eligible for Study:
    All
    Accepts Healthy Volunteers:
    Yes
    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.

    Contacts and Locations

    Locations

    Site City State Country Postal Code
    1 New York University School of Medicine New York New York United States 10016

    Sponsors and Collaborators

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

    Investigators

    • Principal Investigator: Joshua Chodosh, MD, NYU Langone Health

    Study Documents (Full-Text)

    None provided.

    More Information

    Publications

    None provided.
    Responsible Party:
    NYU Langone Health
    ClinicalTrials.gov Identifier:
    NCT03327324
    Other Study ID Numbers:
    • 17-00338
    • 1R01NR016461-01A1
    First Posted:
    Oct 31, 2017
    Last Update Posted:
    Dec 10, 2021
    Last Verified:
    Dec 1, 2021
    Studies a U.S. FDA-regulated Drug Product:
    No
    Studies a U.S. FDA-regulated Device Product:
    Yes
    Product Manufactured in and Exported from the U.S.:
    No
    Additional relevant MeSH terms:
    Sleep Initiation and Maintenance Disorders

    Study Results

    No Results Posted as of Dec 10, 2021