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LOCK sleep intervention for Sleep Disorder (40Winks Trial)

N/A
Waitlist Available
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
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
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 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.

Eligible Conditions
  • Sleep Disorder
  • Sleep Disorders
  • Alzheimer's Disease
  • Dementia

40Winks Trial Eligibility Criteria

Inclusion Criteria

You may be eligible if you check “Yes” for the criteria below

40Winks Trial 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

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 (change from baseline - decrease, increase, same)
Pain - Resident Report (change from baseline - decrease, increase, same)
Pain - Staff Report (change from baseline - decrease, increase, same)
+2 more

40Winks Trial Design

1Treatment groups
Experimental Treatment
Group I: LOCK sleep interventionExperimental Treatment1 Intervention
Nursing home staff receive the LOCK sleep intervention training and thus provide to nursing home residents with dementia the LOCK sleep intervention
Treatment
First Studied
Drug Approval Stage
How many patients have taken this drug
LOCK sleep intervention
2021
N/A
~30

Find a Location

Who is running the clinical trial?

Brown UniversityOTHER
456 Previous Clinical Trials
558,331 Total Patients Enrolled
University of Alabama, TuscaloosaLead Sponsor
44 Previous Clinical Trials
19,493 Total Patients Enrolled
University of Massachusetts, LowellOTHER
20 Previous Clinical Trials
10,286 Total Patients Enrolled

Frequently Asked Questions

These questions and answers are submitted by anonymous patients, and have not been verified by our internal team.
Recent research and studies
clinicaltrials.govStudy
Enhancing Sleep Quality for Nursing Home Residents With Dementia
A. Lynn Snow 2021. "Enhancing Sleep Quality for Nursing Home Residents With Dementia". ClinicalTrials.gov. https://clinicaltrials.gov/ct2/show/NCT04533815.
~6 spots leftby Apr 2025
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