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LOCK Sleep Program for Dementia (40Winks Trial)

N/A
Recruiting
Led By Lynn Snow, PhD
Research Sponsored by University of Alabama, Tuscaloosa
Eligibility Criteria Checklist
Specific guidelines that determine who can or cannot participate in a clinical trial
Must have
Be older than 18 years old
Timeline
Screening 3 weeks
Treatment Varies
Follow Up 15 week sleep intervention period
Awards & highlights
No Placebo-Only Group

Summary

This trial aims to help nursing home residents with Alzheimer's disease or related dementias sleep better by testing a specific method. The study will also look at how well this method works in the long term

Who is the study for?
This trial is for nursing home residents aged 50 or older who have Alzheimer's disease or related dementias and are experiencing sleep problems, as identified by their caregivers.
What is being tested?
The study tests the LOCK Sleep Program designed to enhance sleep quality in dementia patients against a period with no intervention. It aims to assess both the effectiveness of the program and how it can be maintained over time.
What are the potential side effects?
Since this trial involves a non-medical intervention focusing on improving sleep patterns, there may not be direct side effects like those seen with medications; however, changes in routine could potentially affect each resident differently.

Timeline

Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~15 week sleep intervention period
This trial's timeline: 3 weeks for screening, Varies for treatment, and 15 week sleep intervention period for reporting.

Treatment Details

Study Objectives

Study objectives can provide a clearer picture of what you can expect from a treatment.
Primary study objectives
Sleep (actigraph measurement)
Secondary study objectives
Activities of daily living decline
Pain - Resident Report
Pain - Staff Report
+2 more

Awards & Highlights

No Placebo-Only Group
All patients enrolled in this study will receive some form of active treatment.

Trial Design

2Treatment groups
Experimental Treatment
Group I: Intervention (all NHs receive the intervention):Experimental Treatment1 Intervention
The intervention arm includes a ten-week active intervention phase, then a five-week sustainment phase.
Group II: Control (each NH acts as its own control):Experimental Treatment1 Intervention
Each nursing home serves as its own control. Control data will be collected for 1 week (then the intervention will begin).

Find a Location

Who is running the clinical trial?

University of Massachusetts, LowellOTHER
20 Previous Clinical Trials
9,853 Total Patients Enrolled
The University of Texas Health Science Center, HoustonOTHER
949 Previous Clinical Trials
344,569 Total Patients Enrolled
University of Alabama, TuscaloosaLead Sponsor
46 Previous Clinical Trials
17,122 Total Patients Enrolled
~243 spots leftby Apr 2026
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