Health Behaviors and Time-of-Day: Older Adult Cognitive Function (OA-TIME)

December 12, 2019 updated by: University of Florida

Modifiable Health Behaviors Associated With Time-of-Day Differences in Older Adults' Practice-Related Learning

This is a single-center, observational study design. Enrolled participants will be typically, healthy older adults. Participants will complete daily computerized measures, in addition to continuously wearing an Actiwatch device. The study period will last 2 weeks. The objectives of the study are to examine the impact of sleep, pain, and circadian rhythm on practice-related learning in older adults at their preferred versus nonpreferred times of day.

Study Overview

Status

Completed

Detailed Description

Participants will be asked to review the informed consent and consent to the study prior to any study procedure.

There are four stages to this study: 1. a telephone interview, 2. an in-person interview and completion of questionnaires, 3. an in-home single night sleep recording, and 4. two weeks of computerized cognitive testing, subjective sleep and pain recordings, and wearing a Actiwatch.

During the telephone interview, participants will be asked question about their age, sleep, pain, and medical/mental health history. At a second visit, participants will complete a more in-depth interview of their physical health, mental health, sleep, and pain history. They will complete a brief test of their cognitive functioning. They will also complete 4 questionnaires about their time of day preference and mood. At the third visit, participants will visit the University of Florida to be connected to a machine which will monitor their sleep. Participants will return home to sleep while still connected to the machine and will return the machine to the University of Florida the next day. Participants will complete brief computerized daily questionnaires of sleep and pain and cognitive testing in the morning and evening, and and wear an actigraph (wristwatch-like device) that measures arm movements and ambient light for two weeks.

Study Type

Observational

Enrollment (Actual)

88

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

    • Florida
      • Gainesville, Florida, United States, 32610
        • University of Florida

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

61 years and older (Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Sampling Method

Probability Sample

Study Population

Typically, healthy older adults

Description

Inclusion Criteria:

  • Age of 65 years and older
  • Able to read and speak English
  • Completion of Morningness-Eveningness Questionnaire

Exclusion Criteria:

  • Significant medical or neurological disorder
  • Major psychopathology
  • Pain disorder other than fibromyalgia or osteoarthritis
  • Sleep disorder other than insomnia
  • Cognitive impairment
  • Psychotropic or other medications known to alter sleep
  • Unable to provide informed consent

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Observational Models: Cohort
  • Time Perspectives: Prospective

Cohorts and Interventions

Group / Cohort
Intervention / Treatment
Typically healthy older adults
Adults 65 years and older with only common late-life medical conditions who will complete a screening that includes a Polysomnograph and assessment that includes Actiwatch.
Participants will be screened for sleep disorders other than chronic insomnia with an in-home overnight sleep monitoring. Monitoring will consist of six electroencephalography (EEG) measures, two electrooculography (EOG), and chin electromyography (EMG) according to standard placements. Other channels will include oxygen saturation level, bilateral anterior tibialis EMG, heart rate (EKG), thoracic strain gauge, and a nasal/oral thermistor. A single night of polysomnography will be collected during the 2 weeks of assessment.
Other Names:
  • AURA Recording System, Grass Technologies
This device will be worn on the wrist for 14 continuous days to measure limb movements and ambient light.
Other Names:
  • Actiwatch-L, Mini Mitter

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Cognition as assessed by computerized neuropsychological testing
Time Frame: Morning and evening completion for 14 days
Cognitive domains include processing speed, immediate memory, delayed memory, and executive function
Morning and evening completion for 14 days

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Investigators

  • Principal Investigator: Michael E Robinson, Ph.D., University of Florida

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

March 1, 2015

Primary Completion (Actual)

December 1, 2016

Study Completion (Actual)

December 1, 2016

Study Registration Dates

First Submitted

November 20, 2014

First Submitted That Met QC Criteria

November 20, 2014

First Posted (Estimate)

November 24, 2014

Study Record Updates

Last Update Posted (Actual)

December 13, 2019

Last Update Submitted That Met QC Criteria

December 12, 2019

Last Verified

December 1, 2019

More Information

Terms related to this study

Other Study ID Numbers

  • IRB201400910

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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