Improving Sleep Using Mentored Behavioral and Environmental Restructuring (SLUMBER)
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|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
|Condition or disease||Intervention/treatment||Phase|
|Insomnia||Diagnostic Test: Sleep Using Mentored Behavioral and Environmental Restructuring||Not Applicable|
|Study Type :||Interventional (Clinical Trial)|
|Estimated Enrollment :||120 participants|
|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|
|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
- Sleep assessment using Wrist actigraphy [ Time Frame: 9 Months ]wrist device measures light exposure and sleep/wake time
- 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.
- 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.
- 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).
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
|United States, New York|
|New York University School of Medicine|
|New York, New York, United States, 10016|
|Principal Investigator:||Joshua Chodosh, MD||NYU Langone Health|