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

Alzheimer Disease Clinical Trial

Official title:

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

Clinical Trial Details — Status: Not yet recruiting

Administrative data

• NCT number: NCT06045988
• Other study ID #: 15771
• Secondary ID: 2R44AG058339-02A
• Status: Not yet recruiting
• Phase: Phase 2
• Start date: February 1, 2025
• Est. completion date: April 2025

Study information

• Verified date: May 2024
• Source: Indiana University
• Contact: Bailey B Gardner, BA
• Phone: 812-856-4251
• Email: gardnbai[@]iu.edu
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Not yet recruiting
• Enrollment: 100
• Est. completion date: April 2025
• Est. primary completion date: April 2025
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: All
• Age group: 18 Years and older

Eligibility

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

Related Conditions & MeSH terms

• Alzheimer Disease
• Dementia
• Dyssomnias
• Parasomnias
• Sleep Disturbance

Intervention

Device:
• Non-Contact Sleep Quality Monitor System
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.

Locations

Country	Name	City	State
United States	Indiana University School of Medicine	Indianapolis	Indiana

Sponsors (6)

Lead Sponsor	Collaborator
Indiana University	Innovative Design Labs, Mayo Clinic, National Institute on Aging (NIA), Regenstrief Institute, Inc., University of Minnesota

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Documentation of sleep disorders or treatment	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.	4-weeks
Secondary	Change in Sleep Quality Over Time: Total Nocturnal Sleep Time (TNST)	Total Nocturnal Sleep Time (TNST) will be derived from System Data and Algorithms.	4-weeks
Secondary	Change in Epworth Sleepiness Scale Total Score Over Time	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.	4-weeks
Secondary	Change in QOL-AD Over Time	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-weeks
Secondary	Attitudes Toward Technology	A questionnaire that measures attitudes toward technology created by Jay & Willis 1992.	4-weeks
Secondary	Technology Acceptance Survey Questionnaire	A validated 12-item questionnaire that measures perceptions of technology usefulness and; usability, derived from Davis 1989	4-weeks
Secondary	System Usage	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.	4-weeks
Secondary	Change in Sleep Quality Over Time: Sleep Efficiency (SE)	Sleep Efficiency (SE) will be derived from System Data and Algorithms.	4-weeks
Secondary	Change in Sleep Quality Over Time: Sleep Onset Latency (SOL)	Sleep Onset Latency (SOL) will be derived from System Data and Algorithms.	4-weeks
Secondary	Change in Sleep Quality Over Time: Wake After Sleep Onset (WASO)	Wake After Sleep Onset (WASO) will be derived from System Data and Algorithms.	4-weeks