Automated, Assistive, Non-Contact Sleep Quality Monitor for Individuals With Alzheimer's Disease
For patients and families
In plain language
An automatic summary of structured registry data. It is an orientation aid, not a substitute for the official protocol or a physician assessment.
- What is being studied
- The protocol lists: Non-Contact Sleep Quality Monitor System.
- Who it may be relevant to
- Registry conditions: Alzheimer Disease, Dementia, Sleep Disturbance. Basic parameters: from 18 years · All.
- What needs checking
- Age, condition and sex are only basic indicators. Prior treatment, laboratory values and other mandatory requirements appear in the eligibility criteria below.
- Where it takes place
- United States
- Next step
- Save the trial, show it to the treating physician, and confirm current recruitment with the study center. Costs, documents and travel →
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Overview
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.
Interventions
- 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.
Primary outcome measures
- Documentation of sleep disorders or treatment [Time frame: 4-weeks]
Secondary outcome measures (9)
- Change in Sleep Quality Over Time: Total Nocturnal Sleep Time (TNST) [Time frame: 4-weeks]
- Change in Epworth Sleepiness Scale Total Score Over Time [Time frame: 4-weeks]
- Change in QOL-AD Over Time [Time frame: 4-weeks]
- Attitudes Toward Technology [Time frame: 4-weeks]
- Technology Acceptance Survey Questionnaire [Time frame: 4-weeks]
- System Usage [Time frame: 4-weeks]
- Change in Sleep Quality Over Time: Sleep Efficiency (SE) [Time frame: 4-weeks]
- Change in Sleep Quality Over Time: Sleep Onset Latency (SOL) [Time frame: 4-weeks]
- Change in Sleep Quality Over Time: Wake After Sleep Onset (WASO) [Time frame: 4-weeks]
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
Criteria are shown verbatim from the registry (in English). Final eligibility is always assessed by the study center.
Healthy volunteers: Yes
Study design
- Allocation
- N/A
- Model
- Single group
- Masking
- Open label
- Primary purpose
- Diagnostic
Study locations
United States · 1 center
- Indiana University School of Medicine — Indianapolis
Identifiers
NCT: NCT06045988 · 15771 · 2R44AG058339-02A1