Clinical trial NCT06045988: Automated, Assistive, Non-Contact Sleep Quality Monitor for Individuals With Alzheimer's Disease
Official title: Automated, Assistive, Non-Contact Sleep Quality Monitor for Individuals With Alzheimer's Disease
Study type: INTERVENTIONAL
Overall status: NOT_YET_RECRUITING
Phase: NA
Conditions: Alzheimer Disease
Dementia
Sleep Disturbance
Keywords: Sleep Assessment
Sleep Disorder
Technology
Dementia
Long-Term Care
Sleep Monitoring
Lead sponsor: Indiana University
Sponsor class: OTHER
Collaborators: name: Innovative Design Labs
name: University of Minnesota
name: Mayo Clinic
name: National Institute on Aging (NIA)
name: Regenstrief Institute, Inc.
First posted: 2023-09-21
Enrollment: 100
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Allocation: NA
Intervention model: SINGLE_GROUP
Primary purpose: DIAGNOSTIC

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.

Detailed description: 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.

Eligibility criteria: 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

Primary outcomes:
measure: Documentation of sleep disorders or treatment
timeFrame: 4-weeks
Secondary outcomes:
measure: Change in Sleep Quality Over Time: Total Nocturnal Sleep Time (TNST)
timeFrame: 4-weeks
measure: Change in Epworth Sleepiness Scale Total Score Over Time
timeFrame: 4-weeks
measure: Change in QOL-AD Over Time
timeFrame: 4-weeks
measure: Attitudes Toward Technology
timeFrame: 4-weeks
measure: Technology Acceptance Survey Questionnaire
timeFrame: 4-weeks
measure: System Usage
timeFrame: 4-weeks
measure: Change in Sleep Quality Over Time: Sleep Efficiency (SE)
timeFrame: 4-weeks
measure: Change in Sleep Quality Over Time: Sleep Onset Latency (SOL)
timeFrame: 4-weeks
measure: Change in Sleep Quality Over Time: Wake After Sleep Onset (WASO)
timeFrame: 4-weeks
Other outcomes:
Locations:
city: Indianapolis
country: United States
facility: Indiana University School of Medicine
state: Indiana
Study officials:
affiliation: Indiana University School of Medicine
name: Kathleen Unroe, MD, MHA, MS
role: PRINCIPAL_INVESTIGATOR
References: