Completed

NCT Number: NCT04533815

Enhancing Sleep Quality for Nursing Home Residents With Dementia

This was a pilot study (R61) to prepare for a full clinical trial (R33) aiming to improve clinical outcomes for an important, growing, and vulnerable population-nursing home (NH) residents with Alzheimer's disease or related dementias (ADRDs). The goal was to pilot and refine the research methods and intervention that would be subsequently evaluated in a full implementation trial (hybrid type III). The goal of the evidence-based intervention (LOCK) that was refined in this pilot study and will be evaluated in the subsequent full clinical trial is to improve the sleep of NH residents with ADRD.

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Key information

Conditions

Alzheimer Disease Brain Diseases Central Nervous System Diseases Dementia Mental Disorders Nervous System Diseases Neurocognitive Disorders Neurodegenerative Diseases Neurologic Manifestations Parasomnias Pathological Conditions, Signs and Symptoms Signs and Symptoms Sleep Disorder Sleep Disturbance Sleep Wake Disorders Tauopathies

Age range

50 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

The University of Alabama

Tuscaloosa, Alabama, 35487-0348, United States

About this study

In community (non-VA) NHs [one from each of 3 national NH corporations], the multi-disciplinary research team achieved two aims: (1) refined the LOCK program to focus on sleep for residents with ADRD during this pilot (R61) phase, (2) which prepared the team for the second phase of this two-part NIA-funded grant (the R33 phase) to test the impact and sustainability of this intervention for NH residents with ADRD in an incomplete stepped-wedge randomized controlled trial.

THIS PILOT STUDY R61 PHASE (1 YEAR; N = 3 NHS; 1 NH PER CORPORATION) HAD THE FOLLOWING SPECIFIC AIMS:

Refine the LOCK sleep program train-the-trainer protocol by implementing and pilot-testing in three NHs.
Test and refine the research methods to: effectively identify eligible NHs and residents; obtain consent; collect primary data from residents and staff (sleep time via actigraph); explore staff impressions of additional sleep measurement devices (Fitbits); transfer primary and secondary data to our data center; and merge all data.

Who can participate

Healthy volunteers accepted: No

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

Inclusion criteria

Nursing home residents aged >=50 years with an Alzheimer disease or related dementia (ADRD) diagnosis, identified by nursing home staff participating in frontline LOCK sleep huddles as having sleep problems

Exclusion criteria

residents with a high risk of OSA who are not being treated for OSA because actigraph measurements are inaccurate in that population.
residents who have a persistent bilateral resting tremor or paralysis in both arms (a subset of persons with Parkinson's disease and related significant tremor-causing diagnoses), due to actigraph measurement inaccuracies

Treatment and study plan

LOCK sleep intervention

Behavioral

Nursing home staff are trained to use a collaborative problem-solving approach to sleep quality improvement using front-line huddling

Primary outcomes

Sleep (Actigraph Measurement)

Time frame: 15 week sleep intervention period

Total sleep time (total minutes asleep each nighttime period - 7pm to 7am)

Sponsors and collaborators

Lead sponsor

University of Alabama, Tuscaloosa

Other

Collaborators

Brown University
The University of Texas Health Science Center, Houston
University of Massachusetts, Lowell
University of Texas at Austin

Registry information

Official study title

Enhancing Sleep Quality for Nursing Home Residents With Dementia: Pragmatic Trial of an Evidence-Based Frontline Huddling Program

Acronym: 40Winks

Important dates

Study start: 2021
Primary completion: 2022
Study completion: 2022
First posted: Sep 1, 2020
Registry last updated: Jan 10, 2024

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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