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Completed

NCT Number: NCT06584136

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.

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Key information

Conditions

Aging Dyssomnias Mental Disorders Nervous System Diseases Sleep Disorders, Intrinsic Sleep Initiation and Maintenance Disorders Sleep Wake Disorders

Age range

65 year–95 year

Sex eligibility

All sexes

Study type

Observational

Primary location

University of Florida

Gainesville, Florida, 32603, United States

About this study

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.

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

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)

Treatment and study plan

Primary outcomes

  1. 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.

  2. 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.

  3. 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.

  4. Cognitive Function

    Time frame: 6 weeks weekly assessments

    Evaluated using the NIH Toolbox Cognitive Battery, with attention to memory, attention, and processing speed.

Secondary outcomes

  1. Berg Balance Scale (BBS) Score

    Time frame: Pre-intervention (Baseline) and Post-intervention (Week 6)

    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.

  2. Mini-BESTest Score

    Time frame: Weekly assessments over 6 weeks

    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.

  3. Daily Step Count

    Time frame: Daily assessments over 6 weeks recorded by Oura ring

    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.

  4. Toe Strength from ToeScale

    Time frame: 6 weeks weekly assessments

    Measured using the ToeScale for both flexion and extension strength, comparing baseline and post-intervention data.

Other outcomes

  1. Demographic Variables

    Time frame: Week 1 one time measured

    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.

Sponsors and collaborators

Lead sponsor

University of Florida

Other

Registry information

Important dates

Study start
2024
Primary completion
2025
Study completion
2025
First posted
Sep 4, 2024
Registry last updated
Nov 21, 2025

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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