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Intervention (all NHs receive the intervention): 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
40Winks Trial 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.Check my eligibility
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.See study design
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.
40Winks Trial Timeline
Screening ~ 3 weeks3 visits
Treatment ~ Varies
Follow Up ~ 15 week sleep intervention period
Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~15 week sleep intervention period
Treatment Details
Study Objectives
Outcome measures can provide a clearer picture of what you can expect from a treatment.Primary outcome measures
Sleep (actigraph measurement)
Secondary outcome measures
Activities of daily living decline
Pain - Resident Report
Pain - Staff Report
+2 more40Winks 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
1 Trials studying Dementia
23 Patients Enrolled for Dementia
The University of Texas Health Science Center, HoustonOTHER
904 Previous Clinical Trials
320,504 Total Patients Enrolled
9 Trials studying Dementia
2,017 Patients Enrolled for Dementia
University of Alabama, TuscaloosaLead Sponsor
44 Previous Clinical Trials
19,060 Total Patients Enrolled
2 Trials studying Dementia
143 Patients Enrolled for Dementia
Frequently Asked Questions
These questions and answers are submitted by anonymous patients, and have not been verified by our internal team.
Is the process of enrolling participants still ongoing for this medical study?
"Per clinicaltrials.gov, this trial is presently open for enrollment. It was first listed on 9th July 2023 and most recently revised on 11th March 2024."
Answered by AI
What is the current number of participants eligible for enrollment in this clinical research study?
"We are seeking 456 eligible candidates to enroll in this research study. Patients meeting the defined criteria can join from different locations such as Caraday Healthcare, LLC in San Marcos, Texas and National HealthCare Corporation in Murfreesboro, Tennessee."
Answered by AI
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