AgingNCT06584136
Lagged Relationships Between Sleep, Balance, and Cognition in Older Adults
An observational study of Aging, run by University of Florida at 1 site in United States.
Trial summary
This study investigates the use of wearable devices and a sleep diary for tracking sleep and its impact on cognition and balance in older adults over six weeks. It will include routine mobility, balance assessment, and cognitive evaluations, focusing on analyzing the relationships between sleep, mobility, balance, and… Read more about this study
- Who is it for?
- Ages 65 to 95 yearsHealthy volunteers can take part
- Conditions the study is for
- Aging
- How many people
- 18 participants
- Where
- 1 siteUnited States
- Study dates
- 15 Nov 2024to 14 Oct 2025
- Phase
- Observational
- Are there results?
- None posted in the registry
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 65 to 95 years
- All sexes
- Healthy volunteers accepted
- Older adult
Study population: Healthy older adults aged 65 and above were recruited from the University of Florida, local retirement communities, and other relevant sources. They were without severe sleep disorders, cognitive impairment, Significant neurological conditions, or balance impairment.
Who may be able to join
- Healthy older adults aged 65 and above English-speaking Independent in daily activities Able to walk independently or with minimal assistance (cane or walker) Willing to perform weekly assessments in balance and cognition at the University of Florida, Technology for Occupational Performance Lab
Who cannot join
- Severe cognitive impairment (e.g., diagnosed dementia) Severe sleep disorders (e.g., sleep apnea requiring CPAP) Significant neurological conditions (e.g., Parkinson disease, stroke) Unstable medical conditions (e.g., uncontrolled hypertension, recent surgeries)
Trial locations and contacts
1 site in 1 country.
About this study
This study investigates the use of wearable devices and a sleep diary for tracking sleep and its impact on cognition and balance in older adults over six weeks. It will include routine mobility, balance assessment, and cognitive evaluations, focusing on analyzing the relationships between sleep, mobility, balance, and cognition.
Read the detailed description
The study is designed to assess the relationships between sleep quality, balance capabilities, and cognitive functions in older adults. Using a longitudinal approach, participants will be monitored over six weeks with the help of wearable technology (OURA ring) and standardized assessments. Weekly in-person visits will include balance assessments using the Mini-BESTest and mobility tests such as the Timed Up and Go (TUG) test. Cognitive functions will be evaluated using the NIH Toolbox Cognitive Battery. The study aims to identify key sleep indicators that influence balance and cognition, ultimately contributing to improved strategies for maintaining the health and well-being of older adults.
- Conditions
- Aging
- Keywords
- Sleep Quality, Balance Assessment, Older Adults, Cognitive Function, Sleep Monitoring, Wearable device
- Medical subject headings
- Sleep Initiation and Maintenance Disorders
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
| Study group | Role | What they receive |
|---|---|---|
| Oura ring | All participants will be assigned to a single group receiving a smart ring paired with their phone monitoring sleep and daily activity. |
What is being measured
The primary outcome is the main question the study is designed to answer.
Total Sleep Time
Total Sleep Time will be monitored using the OURA ring, calculated as the sum of all sleep stages in minutes each night. Data will be aggregated to provide a daily and weekly average for each participant.
Measured: 6-week daily assessments
Sleep Onset Latency
Sleep Onset Latency, defined as the time taken to transition from wakefulness to sleep, will be recorded by the OURA ring each night. Data will be shown in daily and weekly for each participant.
Measured: Daily assessments over 6 weeks
Sleep Efficiency
Sleep Efficiency will be measured as the ratio of total sleep time to time in bed, expressed as a percentage. The OURA ring will track this nightly, and the data will be summarized as daily data points and a weekly average.
Measured: Daily assessments over 6 weeks
Cognitive Function
Evaluated using the NIH Toolbox Cognitive Battery, with attention to memory, attention, and processing speed.
Measured: 6 weeks weekly assessments
Secondary outcomes (4)
Berg Balance Scale (BBS) Score
The Berg Balance Scale (BBS) will be administered twice, at baseline and at the end of the study period (Week 6), to assess changes in balance performance. The Berg Balance Scale (or BBS) is a widely used clinical test of a person\'s static and dynamic balance abilities.
Measured: Pre-intervention (Baseline) and Post-intervention (Week 6)
Mini-BESTest Score
The Mini-BESTest will be conducted weekly throughout the 6-week study period to evaluate changes in balance performance over time. This test measures dynamic balance, functional mobility, and gait.
Measured: Weekly assessments over 6 weeks
Daily Step Count
Daily step count will be monitored using the OURA ring. The data will be aggregated daily and weekly for each participant to assess overall physical activity levels.
Measured: Daily assessments over 6 weeks recorded by Oura ring
Toe Strength from ToeScale
Measured using the ToeScale for both flexion and extension strength, comparing baseline and post-intervention data.
Measured: 6 weeks weekly assessments
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted4 Sep 2024
- Study start15 Nov 2024
- Primary completion14 Oct 2025
- Study completion14 Oct 2025
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for AgingStudies of the same condition, open and under way.
- More trials run by University of FloridaThe 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
- Observational
- Observational model
- Cohort
- Time perspective
- Prospective
- Enrolment
- 18 participants (actual)
Sponsor and investigators
- Lead sponsor
- University of Florida
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06584136
- Sponsor's protocol ID
- IRB202302147
- Status last verified
- Dec 2024
- First submitted
- 14 Aug 2024
- Last updated
- 21 Nov 2025
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Yes: The de-identified data might be shared with permission from the funder and PI per request.
Study at a glance
From the registry record, last updated by the sponsor on 21 Nov 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Lagged Relationships Between Sleep, Balance, and Cognition in Older Adults
- ClinicalTrials.gov ID
- NCT06584136
- Acronym / sponsor ID
- IRB202302147
- Conditions
- Aging
- Keywords
- Sleep Quality, Balance Assessment, Older Adults, Cognitive Function, Sleep Monitoring, Wearable device
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 18 participants (actual)
- Lead sponsor
- University of FloridaUniversity, hospital or other
- Study start
- 15 Nov 2024 (actual)
- Primary completion
- 14 Oct 2025 (actual)
- Study completion
- 14 Oct 2025 (actual)
- First posted
- 4 Sep 2024 (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 investigates the use of wearable devices and a sleep diary for tracking sleep and its impact on cognition and balance in older adults over six weeks. It will include routine mobility, balance assessment, and cognitive evaluations, focusing on analyzing the relationships between sleep, mobility, balance, and cognition.
Detailed description
The study is designed to assess the relationships between sleep quality, balance capabilities, and cognitive functions in older adults. Using a longitudinal approach, participants will be monitored over six weeks with the help of wearable technology (OURA ring) and standardized assessments. Weekly in-person visits will include balance assessments using the Mini-BESTest and mobility tests such as the Timed Up and Go (TUG) test. Cognitive functions will be evaluated using the NIH Toolbox Cognitive Battery. The study aims to identify key sleep indicators that influence balance and cognition, ultimately contributing to improved strategies for maintaining the health and well-being of older adults.
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Oura ring | – | –All participants will be assigned to a single group receiving a smart ring paired with their phone monitoring sleep and daily activity. |
Who may qualify
- Ages
- 65 to 95 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Older adult
- Study population
- Healthy older adults aged 65 and above were recruited from the University of Florida, local retirement communities, and other relevant sources. They were without severe sleep disorders, cognitive impairment, Significant neurological conditions, or balance impairment.
Key inclusion criteria (1 listed)
- Healthy older adults aged 65 and above English-speaking Independent in daily activities Able to walk independently or with minimal assistance (cane or walker) Willing to perform weekly assessments in balance and cognition at the University of Florida, Technology for Occupational Performance Lab
Key exclusion criteria (1 listed)
- Severe cognitive impairment (e.g., diagnosed dementia) Severe sleep disorders (e.g., sleep apnea requiring CPAP) Significant neurological conditions (e.g., Parkinson disease, stroke) Unstable medical conditions (e.g., uncontrolled hypertension, recent surgeries)
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Primary outcome
Total Sleep Time
Time frame: 6-week daily assessments
Total Sleep Time will be monitored using the OURA ring, calculated as the sum of all sleep stages in minutes each night. Data will be aggregated to provide a daily and weekly average for each participant.
Sleep Onset Latency
Time frame: Daily assessments over 6 weeks
Sleep Onset Latency, defined as the time taken to transition from wakefulness to sleep, will be recorded by the OURA ring each night. Data will be shown in daily and weekly for each participant.
Sleep Efficiency
Time frame: Daily assessments over 6 weeks
Sleep Efficiency will be measured as the ratio of total sleep time to time in bed, expressed as a percentage. The OURA ring will track this nightly, and the data will be summarized as daily data points and a weekly average.
Cognitive Function
Time frame: 6 weeks weekly assessments
Evaluated using the NIH Toolbox Cognitive Battery, with attention to memory, attention, and processing speed.
4 secondary outcomes
Berg Balance Scale (BBS) Score
Time frame: Pre-intervention (Baseline) and Post-intervention (Week 6)
Mini-BESTest Score
Time frame: Weekly assessments over 6 weeks
Daily Step Count
Time frame: Daily assessments over 6 weeks recorded by Oura ring
Toe Strength from ToeScale
Time frame: 6 weeks weekly assessments
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 21 Nov 2025.
- Individual participant dataSharing planned: Yes. The de-identified data might be shared with permission from the funder and PI per request.
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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. This study is not recruiting at the moment.
The record lists no contact. Use the official record to reach the sponsor.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Aging, run by University of Florida 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 1 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: finished, as of the sponsor's last update on 21 Nov 2025. 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?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Total Sleep Time (time frame: 6-week daily assessments). The study lists 4 primary outcomes in all. 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 21 Nov 2025.