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

February 9, 2026 updated by: Kathleen T. Unroe, Indiana University

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.

Study Overview

Status

Not yet recruiting

Conditions

Intervention / Treatment

Detailed Description

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.

Study Type

Interventional

Enrollment (Estimated)

100

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Contact

  • Name: Kathleen Unroe, MD, MHA, MS
  • Phone Number: 317-274-9227
  • Email: kunroe@iu.edu

Study Contact Backup

  • Name: Richard Holden, PhD, MS
  • Phone Number: 317-278-5323
  • Email: rjholden@iu.edu

Study Locations

  • United States
    • Indiana
      • Indianapolis, Indiana, United States, 46202
        • Indiana University School of Medicine
        • Contact:
          • Kathleen Unroe, MD, MHA, MS
          • Phone Number: 317-274-9227
          • Email: kunroe@iu.edu
        • Contact:

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

  • Adult
  • Older Adult

Accepts Healthy Volunteers

Yes

Description

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.

Exclusion Criteria:

  • Currently on hospice

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Diagnostic
  • Allocation: N/A
  • Interventional Model: Single Group Assignment
  • Masking: None (Open Label)

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Experimental: Long-Term Care Facility Residents with Alzheimer's Disease or other Related Dementias
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.

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Documentation of sleep disorders or treatment
Time Frame: 4-weeks
Primary outcome documentation of diagnosis, or evidence of treatment of sleep disorders, will be obtained through review of the medical record. Evidence of such a diagnosis or treatment could be indicated in nursing notes, physician notes, psychoactive or sedative medication changes, new ICD 10 sleep disorder diagnoses, medical orders for sleep studies or sleep medicine consults, all contained in the medical record.
4-weeks

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Change in Sleep Quality Over Time: Total Nocturnal Sleep Time (TNST)
Time Frame: 4-weeks
Total Nocturnal Sleep Time (TNST) will be derived from System Data and Algorithms.
4-weeks
Change in Epworth Sleepiness Scale Total Score Over Time
Time Frame: 4-weeks
The Epworth Sleepiness Scale is a validated, self-report measure of sleepiness. It is an 8-item questionnaire that measures one's tendency to become sleepy using a scale from 0 (no chance of dozing) to 3 (high chance of dozing). The total score is based on a scale of 0 to 24, with a score of 24 indicating the potential need for medical attention.
4-weeks
Change in QOL-AD Over Time
Time Frame: 4-weeks
The Quality-Of-Life-Alzheimer's Disease (QOL-AD) instrument is a 13-item questionnaire that measures the domains of physical condition, mood, memory, functional abilities, interpersonal relationships, ability to participate in meaningful activities, financial situation, and global assessments of self as a whole and QOL as a whole.
4-weeks
Attitudes Toward Technology
Time Frame: 4-weeks
A questionnaire that measures attitudes toward technology created by Jay & Willis 1992.
4-weeks
Technology Acceptance Survey Questionnaire
Time Frame: 4-weeks

A validated 12-item questionnaire that measures perceptions of technology usefulness and

usability, derived from Davis 1989
4-weeks
System Usage
Time Frame: 4-weeks
The total number of days out of 28 that the system collected data, and the number of times the System Sleep Data User Interface was accessed.
4-weeks
Change in Sleep Quality Over Time: Sleep Efficiency (SE)
Time Frame: 4-weeks
Sleep Efficiency (SE) will be derived from System Data and Algorithms.
4-weeks
Change in Sleep Quality Over Time: Sleep Onset Latency (SOL)
Time Frame: 4-weeks
Sleep Onset Latency (SOL) will be derived from System Data and Algorithms.
4-weeks
Change in Sleep Quality Over Time: Wake After Sleep Onset (WASO)
Time Frame: 4-weeks
Wake After Sleep Onset (WASO) will be derived from System Data and Algorithms.
4-weeks

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Indiana University

Collaborators

Mayo Clinic
National Institute on Aging (NIA)
University of Minnesota
Regenstrief Institute, Inc.
Innovative Design Labs

Investigators

  • Principal Investigator: Kathleen Unroe, MD, MHA, MS, Indiana University School of Medicine

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Estimated)

February 1, 2026

Primary Completion (Estimated)

August 1, 2026

Study Completion (Estimated)

August 1, 2026

Study Registration Dates

First Submitted

August 7, 2023

First Submitted That Met QC Criteria

September 13, 2023

First Posted (Actual)

September 21, 2023

Study Record Updates

Last Update Posted (Actual)

February 11, 2026

Last Update Submitted That Met QC Criteria

February 9, 2026

Last Verified

February 1, 2026

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • 15771
  • 2R44AG058339-02A1 (U.S. NIH Grant/Contract)

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

NO

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

Yes

product manufactured in and exported from the U.S.

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

Clinical Trials on Dementia

Clinical Trials on Non-Contact Sleep Quality Monitor System

Search Similar Trials

Sponsors and Collaborators

Medical Conditions

Drug Interventions

CROs by country

CROs in Türkiye

Conditions

Rare Diseases

Drug Interventions

Dietary Supplements

Sponsor/Collaborators

Locations

Subscribe