Lagged Relationships Between Sleep, Balance, and Cognition in Older Adults

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.

Study Overview

• Status: Completed
• Conditions: Aging

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 Type: Observational
• Enrollment (Actual): 18

Contacts and Locations

Study Locations

• United States
  • Florida
    • Gainesville, Florida, United States, 32603
      • University of Florida

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: Older Adult
• Accepts Healthy Volunteers: Yes

• Sampling Method: Non-Probability Sample

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.

Description

Inclusion Criteria:

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

Exclusion Criteria:

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)

Study Plan

How is the study designed?

Number of groups / cohorts

1

Cohorts and Interventions

Group / Cohort
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 the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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.	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.	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.	Daily assessments over 6 weeks
Cognitive Function	Evaluated using the NIH Toolbox Cognitive Battery, with attention to memory, attention, and processing speed.	6 weeks weekly assessments

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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.	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.	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.	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.	6 weeks weekly assessments

Other Outcome Measures

Outcome Measure	Measure Description	Time Frame
Demographic Variables	Demographic data, including age, gender, pre-existing conditions, and medical history, will be collected at the baseline (before the intervention begins). This data will be used to analyze participant characteristics and potential correlations with outcome measures.	Week 1 one time measured

Collaborators and Investigators

• Sponsor: University of Florida

Study record dates

Study Major Dates

• Study Start (Actual): November 15, 2024
• Primary Completion (Actual): October 14, 2025
• Study Completion (Actual): October 14, 2025

Study Registration Dates

• First Submitted: August 14, 2024
• First Submitted That Met QC Criteria: August 29, 2024
• First Posted (Actual): September 4, 2024

Study Record Updates

• Last Update Posted (Actual): November 21, 2025
• Last Update Submitted That Met QC Criteria: November 20, 2025
• Last Verified: December 1, 2024

More Information

Terms related to this study

• Keywords: Older Adults; Sleep Quality; Cognitive Function; Wearable device; Balance Assessment; Sleep Monitoring
• Additional Relevant MeSH Terms: Nervous System Diseases; Mental Disorders; Sleep Wake Disorders; Sleep Disorders, Intrinsic; Dyssomnias; Sleep Initiation and Maintenance Disorders
• Other Study ID Numbers: IRB202302147

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: YES
• IPD Plan Description: The de-identified data might be shared with permission from the funder and PI per request.
• IPD Sharing Time Frame: After study completion and publication of primary outcomes.
• IPD Sharing Access Criteria: Only de-identified data will be shared with permission from the funder and PI per request.
• IPD Sharing Supporting Information Type: STUDY_PROTOCOL

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No