Working…
ClinicalTrials.gov
ClinicalTrials.gov Menu

Improving Sleep Using Mentored Behavioral and Environmental Restructuring (SLUMBER)

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT03327324
Recruitment Status : Suspended (Due to the COVID19 pandemic, as of March 14, 2020, all nursing homes in New York were on lockdown, as a result, all of the recruitment efforts have been on pause until further notice.)
First Posted : October 31, 2017
Last Update Posted : January 5, 2021
Sponsor:
Collaborators:
National Institutes of Health (NIH)
National Institute of Nursing Research (NINR)
Information provided by (Responsible Party):
NYU Langone Health

Study Description
Go to 
Top of Page Study Description Study Design Arms and Interventions Outcome Measures Eligibility Criteria Contacts and Locations More Information
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
Insomnia Diagnostic Test: Sleep Using Mentored Behavioral and Environmental Restructuring Not Applicable

Detailed Description:
This is a study to test the effects of improved sleep quality on downstream functional/psychosocial outcomes.
Study Design
Go to 
Top of Page Study Description Study Design Arms and Interventions Outcome Measures Eligibility Criteria Contacts and Locations More Information

Layout table for study information
Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 120 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 : March 27, 2018
Estimated Primary Completion Date : August 2021
Estimated Study Completion Date : August 2021
Arms and Interventions
Go to 
Top of Page Study Description Study Design Arms and Interventions Outcome Measures Eligibility Criteria Contacts and Locations More Information

Arm Intervention/treatment
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 Name: SLUMBER


Outcome Measures
Go to 
Top of Page Study Description Study Design Arms and Interventions Outcome Measures Eligibility Criteria Contacts and Locations More Information

Primary Outcome Measures :
  1. Sleep assessment using Wrist actigraphy [ Time Frame: 9 Months ]
    wrist device measures light exposure and sleep/wake time

  2. Measure of Subjective sleep quality using Pittsburgh Sleep Quality Index (PSQI) [ Time Frame: 12 Months ]
    The Pittsburgh Sleep Quality Index (PSQI) is an effective instrument used to measure the quality and patterns of sleep in adults. It differentiates "poor" from "good" sleep quality by measuring seven areas (components):subjective sleep quality, sleep latency, sleep duration, habitual sleep efficiency, sleep disturbances, use of sleeping medications, and daytime dysfunction over the last month.

  3. Measure of Mood using Brief Anxiety and Depression Scale (BADS) [ Time Frame: 12 Months ]
    Total score is determined by adding together the scores for each of the 4 items. Scores are rated as normal (0-2), mild (3-5),moderate (6-8), and severe (9-12). Any woman with a positive screen (mild, moderate or severe) should be assessed for suicidal ideation. A positive score, the presence of suicidal ideation and/or your clinical judgment can indicate that further assessment is warranted.

  4. Brief Cognitive Assessment Tool (BCAT) [ Time Frame: 12 Months ]
    consists of five assessment tools that allow the clinician or administrator to accurately assess current cognitive and mood functioning. There are 21 items and the total possible score is 50 points. The full BCAT can be administered in 10-15 minutes by professionals and techs, is sensitive to the full spectrum of cognitive functioning (normal, MCI, mild dementia, moderate-severe dementia), produces separate Memory Factor and Executive Functions Factor scores, and can predict basic and instrumental activities of daily living (ADL, IADL).


Eligibility Criteria
Go to 
Top of Page Study Description Study Design Arms and Interventions Outcome Measures Eligibility Criteria Contacts and Locations More Information

Information from the National Library of Medicine

Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the contacts provided below. For general information, Learn About Clinical Studies.


Layout table for eligibility information
Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   Yes
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.
Contacts and Locations
Go to 
Top of Page Study Description Study Design Arms and Interventions Outcome Measures Eligibility Criteria Contacts and Locations More Information

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT03327324


Locations
Layout table for location information
United States, New York
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
Layout table for investigator information
Principal Investigator: Joshua Chodosh, MD NYU Langone Health
More Information
Go to 
Top of Page Study Description Study Design Arms and Interventions Outcome Measures Eligibility Criteria Contacts and Locations More Information
Layout table for additonal information
Responsible Party: NYU Langone Health
ClinicalTrials.gov Identifier: NCT03327324    
Other Study ID Numbers: 17-00338
1R01NR016461-01A1 ( U.S. NIH Grant/Contract )
First Posted: October 31, 2017    Key Record Dates
Last Update Posted: January 5, 2021
Last Verified: December 2020

Layout table for additional information
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:
Layout table for MeSH terms
Sleep Initiation and Maintenance Disorders
Sleep Disorders, Intrinsic
Dyssomnias
 Sleep Wake Disorders
Nervous System Diseases
Mental Disorders