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

NCT06584136 | Completed

• 1 other identifier: IRB202302147
• Study Type: observational
• Target: 18
• Locations: 1 country
• Sites: 1

Brief 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 cognition.

Conditions

Aging

Keywords

Sleep Quality; Balance Assessment; Older Adults; Cognitive Function; Sleep Monitoring; Wearable device

Outcome Measures

Primary Outcomes (4)

• 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 Outcomes (4)

• Berg Balance Scale (BBS) Score

  Pre-intervention (Baseline) and Post-intervention (Week 6)

• Mini-BESTest Score

  Weekly assessments over 6 weeks

• Daily Step Count

  Daily assessments over 6 weeks recorded by Oura ring

• Toe Strength from ToeScale

  6 weeks weekly assessments

Other Outcomes (1)

• Demographic Variables

  Week 1 one time measured

Study Arms (1)

Oura ring

All participants will be assigned to a single group receiving a smart ring paired with their phone monitoring sleep and daily activity.

Eligibility Criteria

• Age: 65 Years - 95 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Older Adult (65+)
• 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.

You may qualify if:

• 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

You may not qualify if:

• 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)

Sponsors & Collaborators

• University of Florida: lead

Study Sites (1)

University of Florida

Gainesville, Florida, 32603, United States

Location

MeSH Terms

Conditions

Sleep Initiation and Maintenance Disorders

Condition Hierarchy (Ancestors)

Sleep Disorders, Intrinsic; Dyssomnias; Sleep Wake Disorders; Nervous System Diseases; Mental Disorders

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: PROSPECTIVE
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: August 14, 2024
• First Posted: September 4, 2024
• Study Start: November 15, 2024
• Primary Completion: October 14, 2025
• Study Completion: October 14, 2025
• Last Updated: November 21, 2025

Record last verified: 2024-12

Data Sharing

• IPD Sharing: Will share
• Shared Documents: STUDY PROTOCOL
• Time Frame: After study completion and publication of primary outcomes.
• Access Criteria: Only de-identified data will be shared with permission from the funder and PI per request.

Locations

US (1)