- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT02300272
Health Behaviors and Time-of-Day: Older Adult Cognitive Function (OA-TIME)
Modifiable Health Behaviors Associated With Time-of-Day Differences in Older Adults' Practice-Related Learning
Study Overview
Status
Conditions
Intervention / Treatment
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
Enrollment (Actual)
Contacts and Locations
Study Locations
-
-
Florida
-
Gainesville, Florida, United States, 32610
- University of Florida
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-
Participation Criteria
Eligibility Criteria
Ages Eligible for Study
Accepts Healthy Volunteers
Genders Eligible for Study
Sampling Method
Study Population
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
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:
This device will be worn on the wrist for 14 continuous days to measure limb movements and ambient light.
Other Names:
|
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
Sponsor
Investigators
- Principal Investigator: Michael E Robinson, Ph.D., University of Florida
Study record dates
Study Major Dates
Study Start
Primary Completion (Actual)
Study Completion (Actual)
Study Registration Dates
First Submitted
First Submitted That Met QC Criteria
First Posted (Estimate)
Study Record Updates
Last Update Posted (Actual)
Last Update Submitted That Met QC Criteria
Last Verified
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)?
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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