Health TrialsbyHealthPanel

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

ConditionsAlzheimer DiseaseDementiaSleep Disturbance
Trial statusNot yet recruiting
Trial phaseNot applicable
Trial typeInterventional
Biological sexAll
Age18+
SponsorIndiana University

About 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.

Eligibility criteria

This trial accepts healthy volunteers

Qualifiers

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.

Disqualifiers

Currently on hospice

Trial design

Design model

Single group

Treatments tested in this trial

  • Non-Contact Sleep Quality Monitor System

    Device

    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.

Treatment groups

100 Participants
are divided into 1 treatment group
Group A: Long-Term Care Facility Residents with Alzheimer's Disease or other Related DementiasExperimental treatment 1 intervention

Trial outcomes

Primary outcomes

1

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.

Time frame
4-weeks

Secondary outcomes

1

Change in Sleep Quality Over Time: Total Nocturnal Sleep Time (TNST)

Total Nocturnal Sleep Time (TNST) will be derived from System Data and Algorithms.

Time frame
4-weeks
2

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.

Time frame
4-weeks
3

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.

Time frame
4-weeks
4

Attitudes Toward Technology

A questionnaire that measures attitudes toward technology created by Jay \& Willis 1992.

Time frame
4-weeks

Other outcomes

Sponsors and contacts

Click on the lead sponsor to view all of their trials.

Indiana University

Lead sponsor

Innovative Design Labs

Collaborator

University of Minnesota

Collaborator

Mayo Clinic

Collaborator

National Institute on Aging (NIA)

Collaborator

Regenstrief Institute, Inc.

Collaborator

Source ClinicalTrials.gov

This trial is not recruiting at the moment. You can still explore other options: