Non-Contact Sleep Monitor for Alzheimer's Disease

Overseen By Richard Holden, PhD, MS

Age: 18+

Sex: Any

Trial Phase: Academic

Sponsor: Indiana University

Disqualifiers: Hospice

No Placebo Group All trial participants will receive the active study treatment (no placebo)

Compensation: Varies

Number of Visits: Unknown

What You Need to Know Before You Apply

What is the purpose of this trial?

This trial aims to evaluate the effectiveness of a new Non-Contact Sleep Quality Monitor System for individuals with Alzheimer's Disease or related dementias in long-term care facilities. The goal is to determine if access to real-time sleep data aids in the early detection of sleep problems, leading to better treatment and improved sleep. The trial involves monitoring sleep for four weeks and comparing data between participants who receive the sleep data and those who do not. Individuals with Alzheimer's Disease who have resided in a long-term care facility for at least 30 days may be suitable candidates for this study. As an unphased trial, this study offers participants the chance to contribute to innovative research that could enhance sleep management for those with Alzheimer's.

Will I have to stop taking my current medications?

The trial information does not specify whether you need to stop taking your current medications.

What prior data suggests that the Non-Contact Sleep Quality Monitor System is safe for individuals with Alzheimer's Disease or Related Dementias?

In a previous study, caregivers found the Non-Contact Sleep Quality Monitor easy to use and helpful in preventing nighttime injuries. This finding indicates that the device is safe for people with Alzheimer's Disease and similar conditions. No reports of harm or negative effects emerged from using the monitor. Instead, it provided valuable information to caregivers, enhancing safety for those being monitored. The evidence shows that the monitor is well-tolerated and can be a useful tool for managing sleep quality in long-term care. ^{1 2 3 4 5}

Why are researchers excited about this trial?

Researchers are excited about the Non-Contact Sleep Quality Monitor System because it offers a new way to manage Alzheimer's disease by focusing on sleep patterns without direct contact. Unlike traditional methods, which often involve medications or wearable devices to track sleep, this system uses advanced sensors to monitor sleep quality remotely, making it more comfortable and less intrusive for patients. By providing real-time insights into sleep disturbances, it has the potential to improve the quality of care for residents in long-term care facilities with Alzheimer's and related dementias. This approach could lead to better understanding and management of sleep issues, which are common in these patients and can significantly impact their overall health.

What evidence suggests that the Non-Contact Sleep Monitor is effective for Alzheimer's Disease?

Research shows that non-contact sleep monitors can identify sleep problems in people with Alzheimer's Disease (AD). These devices track sleep without physical contact, which benefits those in long-term care. This trial will evaluate the Non-Contact Sleep Quality Monitor System for residents with Alzheimer's Disease or related dementias. Studies have found that sleep issues are common in AD, and better sleep monitoring can lead to improved treatments. Early results suggest that sharing real-time sleep data with healthcare providers simplifies the identification and treatment of sleep problems. This could enhance overall sleep quality and reduce daytime inactivity for those with AD. ^{1 6 7 8 9}

Who Is on the Research Team?

Kathleen Unroe, MD, MHA, MS

Principal Investigator

Indiana University School of Medicine

Are You a Good Fit for This Trial?

This trial is for long-term care residents with Alzheimer's or related dementias who've been at the facility for at least 30 days. Participants can join themselves or through a legal rep if they can't make decisions. It's not open to those on hospice.

Inclusion Criteria

I have been diagnosed with Alzheimer's Disease or a related dementia.

Residents of long-term care (LTC) facility study site location for a minimum of 30 days

I or my legal representative agree to participate in the study.

Exclusion Criteria

I am currently receiving hospice care.

Timeline for a Trial Participant

Screening

Participants are screened for eligibility to participate in the trial

2-4 weeks

Control Condition

System Sleep Data is collected but not shared with LTC staff or healthcare providers

2 weeks

Data collection only

Intervention Condition

System Sleep Data is shared with LTC staff and healthcare providers to improve sleep disorder detection and treatment

2 weeks

Data sharing and monitoring

Follow-up

Participants are monitored for changes in sleep quality and treatment effectiveness

4 weeks

What Are the Treatments Tested in This Trial?

Interventions

• Non-Contact Sleep Quality Monitor System

Trial Overview The study tests a Non-Contact Sleep Quality Monitor System in monitoring sleep quality of individuals with Alzheimer's in long-term care. The impact of sharing real-time sleep data with caregivers on detecting and treating sleep disturbances is evaluated.

How Is the Trial Designed?

Group I: Long-Term Care Facility Residents with Alzheimer's Disease or other Related Dementias Experimental Treatment 1 Intervention

Who Is Running the Clinical Trial?

Indiana University

Lead Sponsor

Trials

1,063

Recruited

1,182,000+

National Institute on Aging (NIA)

Collaborator

Trials

1,841

Recruited

28,150,000+

Innovative Design Labs

Industry Sponsor

Trials

3

Recruited

230+

Innovative Design Labs

Collaborator

Trials

2

Recruited

220+

Regenstrief Institute, Inc.

Collaborator

Trials

27

Recruited

98,500+

Mayo Clinic

Collaborator

Trials

3,427

Recruited

3,221,000+

University of Minnesota

Collaborator

Trials

1,459

Recruited

1,623,000+

Published Research Related to This Trial

Sleep characteristics in individuals with Alzheimer's disease (AD) and their family caregivers show significant day-to-day variation, with more variability observed between different individuals than within the same individual over time.

Poor sleep in AD patients does not always correlate with poor sleep in their caregivers, indicating that each person's sleep disturbances may require individualized treatment strategies.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Factors associated with concordance and variability of sleep quality in persons with Alzheimer's disease and their caregivers. McCurry, SM., Pike, KC., Vitiello, MV., et al.[2021]

This study aims to improve our understanding of sleep and circadian rhythm disorders in individuals with Alzheimer's Disease (AD) and Mild Cognitive Impairment (MCI-AD) by using advanced sleep measurement technology over a 2-month period, which includes both home-based EEG recordings and wrist-worn actigraphy.

By focusing on micro-architectural sleep measures and compensatory responses to poor sleep, the research seeks to uncover potential targets for interventions that could improve cognitive performance and quality of life in AD patients, while also aiding in early diagnosis of the disease.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Remote evaluation of sleep to enhance understanding of early dementia due to Alzheimer's Disease (RESTED-AD): an observational cohort study protocol. Blackman, J., Morrison, HD., Gabb, V., et al.[2023]

Many patients with Alzheimer's disease experience significant sleep disruptions, which may not only be a symptom of the disease but could also contribute to its progression.

Research suggests that addressing these sleep disturbances could potentially target underlying mechanisms of Alzheimer's, indicating that effective sleep interventions might help modify the disease course, although further large-scale studies are needed to confirm this.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Sleep and its regulation: An emerging pathogenic and treatment frontier in Alzheimer's disease. Kent, BA., Feldman, HH., Nygaard, HB.[2022]

Citations

1. clinicaltrials.gov clinicaltrials.gov/show/NCT06045988

Automated, Assistive, Non-Contact Sleep Quality Monitor ... 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 ...

2. connect.careboxhealth.com connect.careboxhealth.com/en-US/trial/listing/434415

Automated, Assistive, Non-Contact Sleep Quality Monitor for ... 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 ...

3. withpower.com withpower.com/trial/phase-2-alzheimer-disease-1-2024-22f2e

Non-Contact Sleep Monitor for 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 ...

4. alz-journals.onlinelibrary.wiley.com alz-journals.onlinelibrary.wiley.com/doi/10.1002/alz.70758?af=R

Contactless longitudinal monitoring in the home characterizes ... The results describe aging and Alzheimer's disease (AD)–specific alterations in sleep behavior and physiology. Long time spent in bed, late ...

5. sciencedirect.com sciencedirect.com/science/article/pii/S1087079222000788

A systematic review of the validity of non-invasive sleep ... A systematic review of the validity of non-invasive sleep-measuring devices in mid-to-late life adults: Future utility for Alzheimer's disease research.

6. reporter.nih.gov reporter.nih.gov/project-details/10700137

Automated, Assistive, Non-Contact Sleep Quality Monitor for ... A sleep monitoring system specifically designed for care providers of persons with Alzheimer's disease and Alzheimer's Disease Related Dementias (AD/ADRD)

7. aging.jmir.org aging.jmir.org/2025/1/e69175

Advancing Remote Monitoring for Patients With Alzheimer ... Sleep patterns collected from these devices offer valuable insights into an individual's health status, providing clinicians with early warnings ...

8. sciencedirect.com sciencedirect.com/science/article/abs/pii/S1552526008028641

Reducing dangerous nighttime events in persons with ... Caregivers reported satisfaction with the NMS's ease of use and its features and expressed confidence that the system prevented nighttime injuries and home ...

9. pmc.ncbi.nlm.nih.gov pmc.ncbi.nlm.nih.gov/articles/PMC2774792/

Reducing Dangerous Nighttime Events in Persons with ... Briefly, the NMS uses a home security system platform plus a bed occupancy sensor to provide information to the caregiver regarding the whereabouts of the PWD.