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Non-Contact Sleep Monitor for Alzheimer's Disease

Phase 2

Waitlist Available

Led By Kathleen Unroe, MD, MHA, MS

Research Sponsored by Indiana University

Eligibility Criteria Checklist

Specific guidelines that determine who can or cannot participate in a clinical trial

Must have

Diagnosis of Alzheimer's Disease (AD) or Alzheimer's Disease Related Dementias (ADRD)

Be older than 18 years old

Timeline

Screening 3 weeks

Treatment Varies

Follow Up 4-weeks

Awards & highlights

Study Summary

This trial will test if access to sleep quality data helps detect/treat sleep disturbances in people with Alzheimer's, leading to better sleep and less daytime physical inactivity.

Who is the study for?

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.Check my eligibility

What is being tested?

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.See study design

What are the potential side effects?

Since this trial involves non-contact monitoring, there are no direct side effects from the intervention itself. However, changes in treatment based on data may have their own effects.

Eligibility Criteria

Inclusion Criteria

You may be eligible if you check “Yes” for the criteria below

Select...

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

Timeline

Screening ~ 3 weeks3 visits

Treatment ~ Varies

Follow Up ~ 4-weeks

Screening ~ 3 weeks

Treatment ~ Varies

Follow Up ~4-weeks

This trial's timeline: 3 weeks for screening, Varies for treatment, and 4-weeks for reporting.

Treatment Details

Study Objectives

Outcome measures can provide a clearer picture of what you can expect from a treatment.

Primary outcome measures

Documentation of sleep disorders or treatment

Secondary outcome measures

Attitudes Toward Technology

Change in Epworth Sleepiness Scale Total Score Over Time

Change in QOL-AD Over Time

+6 more

Trial Design

1Treatment groups

Experimental Treatment

Group I: Long-Term Care Facility Residents with Alzheimer's Disease or other Related DementiasExperimental Treatment1 Intervention

0 / 1Eligibility criteria met

Find a Location

Who is running the clinical trial?

Indiana UniversityLead Sponsor

980 Previous Clinical Trials

982,882 Total Patients Enrolled

Innovative Design LabsUNKNOWN

1 Previous Clinical Trials

119 Total Patients Enrolled

Regenstrief Institute, Inc.OTHER

26 Previous Clinical Trials

98,377 Total Patients Enrolled

Frequently Asked Questions

These questions and answers are submitted by anonymous patients, and have not been verified by our internal team.

Does the FDA have any sanctioned treatments for those living in Long-Term Care Facilities and suffering from Alzheimer's Disease or other related dementias?

"Our evaluation of the safety for Long-Term Care Facility Residents with Alzheimer's disease or other Related Dementias has resulted in a rating of 2 due to the fact that this is Phase 2 trial and there is some evidence demonstrating its safety but no proof for efficacy."

Answered by AI

Is this research project currently seeking participants?

"The information provided on clinicaltrials.gov indicates that this medical trial is not actively looking for candidates. Initially posted in February of 2024 and last updated in September of 2023, the study has yet to accept new patients; however, 887 other trials are currently enrolling participants at this time."

Answered by AI

Recent research and studies

clinicaltrials.govStudy

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

Kathleen T. Unroe 2024. "Automated, Assistive, Non-Contact Sleep Quality Monitor for Individuals With Alzheimer's Disease". ClinicalTrials.gov. https://clinicaltrials.gov/ct2/show/NCT06045988.

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