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

Primary Purpose

Alzheimer Disease, Dementia, Sleep Disturbance

Status
Not yet recruiting
Phase
Phase 2
Locations
United States
Study Type
Interventional
Intervention
Non-Contact Sleep Quality Monitor System
Sponsored by
Indiana University
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional diagnostic trial for Alzheimer Disease focused on measuring Sleep Assessment, Sleep Disorder, Technology, Dementia, Long-Term Care, Sleep Monitoring

Eligibility Criteria

18 Years - undefined (Adult, Older Adult)All SexesAccepts Healthy Volunteers

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

Sites / Locations

  • Indiana University School of Medicine

Arms of the Study

Arm 1

Arm Type

Experimental

Arm Label

Long-Term Care Facility Residents with Alzheimer's Disease or other Related Dementias

Arm Description

Outcomes

Primary Outcome Measures

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.

Secondary Outcome Measures

Change in Sleep Quality Over Time: Total Nocturnal Sleep Time (TNST)
Total Nocturnal Sleep Time (TNST) will be derived from System Data and Algorithms.
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.
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.
Attitudes Toward Technology
A questionnaire that measures attitudes toward technology created by Jay & Willis 1992.
Technology Acceptance Survey Questionnaire
A validated 12-item questionnaire that measures perceptions of technology usefulness and usability, derived from Davis 1989
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.
Change in Sleep Quality Over Time: Sleep Efficiency (SE)
Sleep Efficiency (SE) will be derived from System Data and Algorithms.
Change in Sleep Quality Over Time: Sleep Onset Latency (SOL)
Sleep Onset Latency (SOL) will be derived from System Data and Algorithms.
Change in Sleep Quality Over Time: Wake After Sleep Onset (WASO)
Wake After Sleep Onset (WASO) will be derived from System Data and Algorithms.

Full Information

First Posted
August 7, 2023
Last Updated
September 27, 2023
Sponsor
Indiana University
Collaborators
Innovative Design Labs, University of Minnesota, Mayo Clinic, Regenstrief Institute, Inc.
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1. Study Identification

Unique Protocol Identification Number
NCT06045988
Brief Title
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

2. Study Status

Record Verification Date
September 2023
Overall Recruitment Status
Not yet recruiting
Study Start Date
February 1, 2024 (Anticipated)
Primary Completion Date
April 2025 (Anticipated)
Study Completion Date
April 2025 (Anticipated)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Indiana University
Collaborators
Innovative Design Labs, University of Minnesota, Mayo Clinic, Regenstrief Institute, Inc.

4. Oversight

Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
Yes
Product Manufactured in and Exported from the U.S.
No
Data Monitoring Committee
No

5. Study Description

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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Alzheimer Disease, Dementia, Sleep Disturbance
Keywords
Sleep Assessment, Sleep Disorder, Technology, Dementia, Long-Term Care, Sleep Monitoring

7. Study Design

Primary Purpose
Diagnostic
Study Phase
Phase 2
Interventional Study Model
Single Group Assignment
Masking
None (Open Label)
Allocation
N/A
Enrollment
100 (Anticipated)

8. Arms, Groups, and Interventions

Arm Title
Long-Term Care Facility Residents with Alzheimer's Disease or other Related Dementias
Arm Type
Experimental
Intervention Type
Device
Intervention Name(s)
Non-Contact Sleep Quality Monitor System
Intervention Description
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.
Primary Outcome Measure Information:
Title
Documentation of sleep disorders or treatment
Description
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.
Time Frame
4-weeks
Secondary Outcome Measure Information:
Title
Change in Sleep Quality Over Time: Total Nocturnal Sleep Time (TNST)
Description
Total Nocturnal Sleep Time (TNST) will be derived from System Data and Algorithms.
Time Frame
4-weeks
Title
Change in Epworth Sleepiness Scale Total Score Over Time
Description
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.
Time Frame
4-weeks
Title
Change in QOL-AD Over Time
Description
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.
Time Frame
4-weeks
Title
Attitudes Toward Technology
Description
A questionnaire that measures attitudes toward technology created by Jay & Willis 1992.
Time Frame
4-weeks
Title
Technology Acceptance Survey Questionnaire
Description
A validated 12-item questionnaire that measures perceptions of technology usefulness and usability, derived from Davis 1989
Time Frame
4-weeks
Title
System Usage
Description
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.
Time Frame
4-weeks
Title
Change in Sleep Quality Over Time: Sleep Efficiency (SE)
Description
Sleep Efficiency (SE) will be derived from System Data and Algorithms.
Time Frame
4-weeks
Title
Change in Sleep Quality Over Time: Sleep Onset Latency (SOL)
Description
Sleep Onset Latency (SOL) will be derived from System Data and Algorithms.
Time Frame
4-weeks
Title
Change in Sleep Quality Over Time: Wake After Sleep Onset (WASO)
Description
Wake After Sleep Onset (WASO) will be derived from System Data and Algorithms.
Time Frame
4-weeks

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
Accepts Healthy Volunteers
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
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
Bailey B Gardner, BA
Phone
812-856-4251
Email
gardnbai@iu.edu
First Name & Middle Initial & Last Name or Official Title & Degree
Kathleen Unroe, MD, MHA, MS
Phone
317-274-9227
Email
kunroe@iu.edu
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Kathleen Unroe, MD, MHA, MS
Organizational Affiliation
Indiana University School of Medicine
Official's Role
Principal Investigator
Facility Information:
Facility Name
Indiana University School of Medicine
City
Indianapolis
State/Province
Indiana
ZIP/Postal Code
46202
Country
United States
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Bailey Gardner, BA
Phone
812-856-4251
Email
gardnbai@iu.edu
First Name & Middle Initial & Last Name & Degree
Kathleen Unroe, MD, MHA, MS
Phone
317-274-9227
Email
kunroe@iu.edu

12. IPD Sharing Statement

Plan to Share IPD
No

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

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