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NCT Number: NCT06045988

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

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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Key information

Conditions

Alzheimer Disease Brain Diseases Central Nervous System Diseases Dementia Mental Disorders Nervous System Diseases Neurocognitive Disorders Neurodegenerative Diseases Neurologic Manifestations Parasomnias Pathological Conditions, Signs and Symptoms Signs and Symptoms Sleep Disturbance Sleep Wake Disorders Tauopathies

Age range

18 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

About this study

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.

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

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.

Primary outcomes

  1. 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.

Secondary outcomes

  1. 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.

  2. 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.

  3. 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. Attitudes Toward Technology

    Time frame: 4-weeks

    A questionnaire that measures attitudes toward technology created by Jay & Willis 1992.

  5. 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

  6. 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.

  7. Change in Sleep Quality Over Time: Sleep Efficiency (SE)

    Time frame: 4-weeks

    Sleep Efficiency (SE) will be derived from System Data and Algorithms.

  8. 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.

  9. 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.

Study contacts

Contact information is provided by the study sponsor or research team.

Kathleen Unroe, MD, MHA, MS

CONTACT

[email protected]

317-274-9227

Richard Holden, PhD, MS

CONTACT

[email protected]

317-278-5323

Sponsors and collaborators

Lead sponsor

Indiana University

Other

Collaborators

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

Registry information

Important dates

Study start
2026
Primary completion
2026
Study completion
2026
First posted
Sep 21, 2023
Registry last updated
Jun 26, 2026

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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