Alzheimer DiseaseNCT06045988
Automated, Assistive, Non-Contact Sleep Quality Monitor for Individuals With Alzheimer's Disease
A study testing Non-Contact Sleep Quality Monitor System in people with Alzheimer Disease and Dementia, run by Indiana University at 1 site in United States.
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). Read more about this study
- Who is it for?
- Ages 18 years and olderHealthy volunteers can take part
- Conditions the study is for
- Alzheimer Disease, Dementia, Sleep Disturbance
- What is being tested?
- Non-Contact Sleep Quality Monitor System
- Type of treatment
- Medical device
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 100 participants
- Where
- 1 siteUnited States
- Study dates
- Jul 2026to Dec 2026
- Phase
- Interventional
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
Who may be able to join
- 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.
Who cannot join
- Currently on hospice
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
United States1 site
Indiana University School of Medicine
Indianapolis, Indiana, 46202
Kathleen Unroe, MD, MHA, MS, 317-274-9227, kunroe@iu.edu
Richard Holden, PhD, 317-278-5323, rjholden@iu.edu
About this study
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.
Read the 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.
- Conditions
- Alzheimer Disease, Dementia, Sleep Disturbance
- Being tested
- Non-Contact Sleep Quality Monitor System
- Keywords
- Sleep Assessment, Sleep Disorder, Technology, Dementia, Long-Term Care, Sleep Monitoring
- Medical subject headings
- Alzheimer Disease, Dementia, Parasomnias, Sleep Wake Disorders
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Non-Contact Sleep Quality Monitor SystemDevice
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.
| Study group | Role | What they receive |
|---|---|---|
| Long-Term Care Facility Residents with Alzheimer's Disease or other Related Dementias | Experimental | Not described Receives: Device: Non-Contact Sleep Quality Monitor System |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: 4-weeks
Secondary outcomes (9)
Change in Sleep Quality Over Time: Total Nocturnal Sleep Time (TNST)
Total Nocturnal Sleep Time (TNST) will be derived from System Data and Algorithms.
Measured: 4-weeks
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.
Measured: 4-weeks
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.
Measured: 4-weeks
Attitudes Toward Technology
A questionnaire that measures attitudes toward technology created by Jay \& Willis 1992.
Measured: 4-weeks
Technology Acceptance Survey Questionnaire
A validated 12-item questionnaire that measures perceptions of technology usefulness and
usability, derived from Davis 1989
Measured: 4-weeks
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.
Measured: 4-weeks
Change in Sleep Quality Over Time: Sleep Efficiency (SE)
Sleep Efficiency (SE) will be derived from System Data and Algorithms.
Measured: 4-weeks
Change in Sleep Quality Over Time: Sleep Onset Latency (SOL)
Sleep Onset Latency (SOL) will be derived from System Data and Algorithms.
Measured: 4-weeks
Change in Sleep Quality Over Time: Wake After Sleep Onset (WASO)
Wake After Sleep Onset (WASO) will be derived from System Data and Algorithms.
Measured: 4-weeks
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted21 Sep 2023
- Study startJul 2026 (estimated)
- Primary completionDec 2026 (estimated)
- Study completionDec 2026 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Alzheimer DiseaseStudies of the same condition, open and under way.
- More trials run by Indiana UniversityThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Diagnosis
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 100 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Indiana University
- Sponsor type
- University, hospital or other
- Collaborators
- Innovative Design Labs, University of Minnesota, Mayo Clinic, National Institute on Aging (NIA), Regenstrief Institute, Inc.
- Responsible party
- Principal investigator, Kathleen T. Unroe, Indiana University
- Investigators
- Kathleen Unroe, MD, MHA, MS, Principal investigator, Indiana University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06045988
- Sponsor's protocol ID
- 15771
- Other IDs
- 2R44AG058339-02A1
- Status last verified
- Feb 2026
- First submitted
- 7 Aug 2023
- Last updated
- 26 Jun 2026
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- Yes
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 26 Jun 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Automated, Assistive, Non-Contact Sleep Quality Monitor for Individuals With Alzheimer's Disease
- ClinicalTrials.gov ID
- NCT06045988
- Acronym / sponsor ID
- 15771
- Conditions
- Alzheimer Disease, Dementia, Sleep Disturbance
- Keywords
- Sleep Assessment, Sleep Disorder, Technology, Dementia, Long-Term Care, Sleep Monitoring
- Study type
- Interventional
- Recruitment status
- Not yet recruiting
- Enrolment
- 100 participants (estimated)
- Lead sponsor
- Indiana UniversityUniversity, hospital or other
- Collaborators
- Innovative Design Labs, University of Minnesota, Mayo Clinic, National Institute on Aging (NIA), Regenstrief Institute, Inc.
- Study start
- Jul 2026 (estimated)
- Primary completion
- Dec 2026 (estimated)
- Study completion
- Dec 2026 (estimated)
- First posted
- 21 Sep 2023 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Diagnosis
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Long-Term Care Facility Residents with Alzheimer's Disease or other Related Dementias | Experimental | Device: Non-Contact Sleep Quality Monitor System |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (3 listed)
- 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.
Key exclusion criteria (1 listed)
- Currently on hospice
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Non-Contact Sleep Quality Monitor SystemResidents 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. | Device | Long-Term Care Facility Residents with Alzheimer's Disease or other Related Dementias |
Primary outcome
Documentation of sleep disorders or treatment
Time frame: 4-weeks
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.
9 secondary outcomes
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
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 26 Jun 2026.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part.
Kathleen Unroe, MD, MHA, MS principal investigator
Indiana University
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Non-Contact Sleep Quality Monitor System in people with Alzheimer Disease and Dementia, run by Indiana University at 1 site in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 3 inclusion and 1 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: opening soon, as of the sponsor's last update on 26 Jun 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Kathleen Unroe, MD, MHA, MS (317-274-9227, kunroe@iu.edu), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Documentation of sleep disorders or treatment (time frame: 4-weeks). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 26 Jun 2026.