Automated, Assistive, Non-Contact Sleep Quality Monitor for Individuals With Alzheimer's Disease
Part of paid clinical trials in Indianapolis, Indiana.
- Sponsor
- Indiana University
- Study ID
- NCT06045988
- Status
- Not Yet Recruiting
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Conditions
- Alzheimer Disease
- Dementia
- Sleep Disturbance
Eligibility Criteria
- Sex
- ALL
- Age
- 18 Years - N/A
- Healthy Volunteers
- Accepted
Interventions
- Non-Contact Sleep Quality Monitor System — DEVICEResidents of long-term care facilities with Alzheimer's or other related dementias will utilize a sleep monitoring device for the four-week period they are involved in the study.
Study Details
This study seeks to evaluate the utility and efficacy of the Non-Contact Sleep Quality Monitor System when used to monitor the sleep quality of individuals living in long-term care (LTC) with either Alzheimer's Disease (AD) or Alzheimer's Disease Related Dementia (ADRD). This before-after comparison trial will be conducted in several LTC facilities to evaluate the effect access to System Sleep Quality Data has on documentation of sleep disorders or treatments and sleep quality change over time for AD/ADRD participants in the intervention group as compared to the control group. All subjects will undergo sleep quality monitoring for 4-weeks. At the end of the first 2-weeks, research staff and LTC facility staff and medical providers will receive access to sleep monitoring data. We hypothesize that when real-time System Sleep Data is shared with LTC staff or healthcare providers, that sleep disturbances will be more readily detected, leading to timelier, better tailored treatment interventions for sleep disturbances, thereby improving sleep quality and decreasing daytime physical inactivity.
Key Dates
- Start date
- Feb 28, 2026
- Status verified
- Feb 2026
- Primary completion
- Aug 31, 2026
- Completion
- Aug 31, 2026
Study Design
- Enrollment
- 100 participants (estimated)
- Allocation
- NA
- Intervention model
- SINGLE_GROUP
- Primary purpose
- DIAGNOSTIC
Arms
- Experimental: Long-Term Care Facility Residents with Alzheimer's Disease or other Related Dementias
Primary Outcome Measure
Documentation of sleep disorders or treatment [ Time Frame: 4-weeks ]
Central Contacts
- Kathleen Unroe, MD, MHA, MS317-274-9227
- Richard Holden, PhD, MS317-278-5323
Locations (1)
| Facility | City | State | ZIP | Site coordinators |
|---|---|---|---|---|
| Indiana University School of Medicine | Indianapolis | Indiana | 46202 |
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