Automated, Assistive, Non-Contact Sleep Quality Monitor for Individuals With Alzheimer's Disease

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

NOT_YET_RECRUITING

Clinical Phase

NA

Total Enrollment

100 participants

Study Classification

INTERVENTIONAL

Study Start Date

2025-10-31

Study Completion Date

2025-12-31

Brief Summary

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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.

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Detailed Description

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The purpose of this study is to evaluate the utility of a Non-Contact Sleep Quality Monitor System and determine the effect that sharing System Sleep Data with long-term care (LTC) staff and healthcare providers has on documentation and treatment of sleep disorders and change in AD/ADRD participant sleep quality. System Sleep Data will be collected for a total of 4-weeks. During the Intervention condition System Sleep Data will be shared for 2-weeks, while in the initial Control condition no System Sleep Data will be shared for 2-weeks. Healthcare providers can prescribe a non-pharmacologic sleep protocol and/or if they so choose, pharmacotherapy to manage sleep disturbances for subjects in either the Intervention or Control condition, in accordance with standard medical practice. The investigators 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.

Conditions

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Alzheimer Disease Dementia Sleep Disturbance

Study Design

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Allocation Method

NA

Intervention Model

SINGLE_GROUP

Primary Study Purpose

DIAGNOSTIC

Blinding Strategy

NONE

Study Groups

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Long-Term Care Facility Residents with Alzheimer's Disease or other Related Dementias

Group Type EXPERIMENTAL

Non-Contact Sleep Quality Monitor System

Intervention Type DEVICE

Residents 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.

Interventions

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Non-Contact Sleep Quality Monitor System

Residents 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.

Intervention Type DEVICE

Eligibility Criteria

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Inclusion Criteria

* Diagnosis of Alzheimer's Disease (AD) or Alzheimer's Disease Related Dementias (ADRD)
* Residents of long-term care (LTC) facility study site location for a minimum of 30 days.
* Willingness to consent to study or when a potential participant lacks decision making capacity (determined by LTC facility clinical provider) willingness of a Legally Authorized Representative (LAR) to consent to study participation on potential participant's behalf.