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

Summary

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.

Conditions

• Alzheimer Disease
• Dementia
• Sleep Disturbance

Interventions

DEVICE

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.

Sponsors & Collaborators

• Innovative Design Labs

  collaborator INDUSTRY

• University of Minnesota

  collaborator OTHER

• Mayo Clinic

  collaborator OTHER

• National Institute on Aging (NIA)

  collaborator NIH

• Regenstrief Institute, Inc.

  collaborator OTHER

• Indiana University

  lead OTHER

Principal Investigators

• Kathleen Unroe, MD, MHA, MS · Indiana University School of Medicine

Study Design

Allocation

NA

Purpose

DIAGNOSTIC

Masking

NONE

Model

SINGLE_GROUP

Eligibility

Min Age

18 Years

Sex

ALL

Healthy Volunteers

Yes

Timeline & Regulatory

Start

2026-02-28

Primary Completion

2026-08-31

Completion

2026-08-31

FDA Device

Yes

Countries

• United States

Study Locations