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

100 Participants Needed

Trial Summary

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 data supports the effectiveness of the Non-Contact Sleep Quality Monitor System treatment for Alzheimer's Disease?

Research shows that sleep disturbances are common in Alzheimer's patients and can worsen the disease. Monitoring sleep patterns, as done by the Non-Contact Sleep Quality Monitor System, may help identify and address these disturbances, potentially improving cognitive performance and quality of life. ^{1 2 3 4 5}

How does the non-contact sleep monitor treatment for Alzheimer's disease differ from other treatments?

The non-contact sleep monitor treatment for Alzheimer's disease is unique because it focuses on understanding and improving sleep patterns without requiring physical contact, unlike traditional sleep studies that often involve wearable devices or in-lab settings. This approach aims to identify sleep-related issues that may contribute to Alzheimer's progression, potentially leading to early diagnosis and new intervention strategies. ^{1 2 4 6 7}

What is the purpose of this trial?

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.

Research Team

Kathleen Unroe, MD, MHA, MS

Principal Investigator

Indiana University School of Medicine

Eligibility Criteria

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

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

Treatment Details

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.

Participant Groups

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+

Findings from Research

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]

References

1. United States pubmed.ncbi.nlm.nih.gov

Factors associated with concordance and variability of sleep quality in persons with Alzheimer's disease and their caregivers. [2021]

2. England 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. [2023]

3. England pubmed.ncbi.nlm.nih.gov

Sleep and its regulation: An emerging pathogenic and treatment frontier in Alzheimer's disease. [2022]

4. Japan pubmed.ncbi.nlm.nih.gov

High frequency of getting out of bed in patients with Alzheimer's disease monitored by non-wearable actigraphy. [2019]

5. England pubmed.ncbi.nlm.nih.gov

Discrepancy between subjective and objective sleep disturbances in early- and moderate-stage Alzheimer disease. [2015]

6. England pubmed.ncbi.nlm.nih.gov

Evaluation of waist-worn actigraphy monitors for the assessment of sleep in older adults with and without Alzheimer's disease. [2022]

7. Italy pubmed.ncbi.nlm.nih.gov

Sleep continuity scale in Alzheimer's disease (SCADS): application in daily clinical practice in an Italian center for dementia. [2021]