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

NCT06045988 | Not Yet Recruiting FDA Device

• 2 other identifiers: 157712R44AG058339-02A1
• Study Type: interventional
• Target: 100
• Locations: 1 country
• Sites: 1

Brief 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

Keywords

Sleep Assessment; Sleep Disorder; Technology; Dementia; Long-Term Care; Sleep Monitoring

Outcome Measures

Primary Outcomes (1)

• Documentation of sleep disorders or treatment

  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 Outcomes (9)

• Change in Sleep Quality Over Time: Total Nocturnal Sleep Time (TNST)

  4-weeks

• Change in Epworth Sleepiness Scale Total Score Over Time

  4-weeks

• Change in QOL-AD Over Time

  4-weeks

• Attitudes Toward Technology

  4-weeks

• Technology Acceptance Survey Questionnaire

  4-weeks

Study Arms (1)

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

EXPERIMENTAL

Device: Non-Contact Sleep Quality Monitor System

Interventions

Non-Contact Sleep Quality Monitor System 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.

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

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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.

You may not qualify if:

• Currently on hospice

Sponsors & Collaborators

• Innovative Design Labs: collaborator
• University of Minnesota: collaborator
• Mayo Clinic: collaborator
• National Institute on Aging (NIA): collaborator
• Regenstrief Institute, Inc.: collaborator
• Indiana University: lead

Study Sites (1)

Indiana University School of Medicine

Indianapolis, Indiana, 46202, United States

Location

MeSH Terms

Conditions

Alzheimer Disease; Dementia; Parasomnias; Sleep Wake Disorders

Condition Hierarchy (Ancestors)

Brain Diseases; Central Nervous System Diseases; Nervous System Diseases; Tauopathies; Neurodegenerative Diseases; Neurocognitive Disorders; Mental Disorders; Neurologic Manifestations; Signs and Symptoms; Pathological Conditions, Signs and Symptoms

Study Officials

• Kathleen Unroe, MD, MHA, MS

  Indiana University School of Medicine

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Kathleen Unroe, MD, MHA, MS

CONTACT

317-274-9227; kunroe@iu.edu

Richard Holden, PhD, MS

CONTACT

317-278-5323; rjholden@iu.edu

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NA
• Masking: NONE
• Purpose: DIAGNOSTIC
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Professor of Medicine, Geriatrics

Study Record Dates

• First Submitted: August 7, 2023
• First Posted: September 21, 2023
• Study Start: February 1, 2026
• Primary Completion (Estimated): August 1, 2026
• Study Completion (Estimated): August 1, 2026
• Last Updated: February 11, 2026

Record last verified: 2026-02

Data Sharing

• IPD Sharing: Will not share

Locations

US (1)