Health Behaviors and Time-of-Day: Older Adult Cognitive Function (OA-TIME)
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|ClinicalTrials.gov Identifier: NCT02300272|
Recruitment Status : Completed
First Posted : November 24, 2014
Last Update Posted : December 26, 2016
|Condition or disease||Intervention/treatment|
|Alteration of Cognitive Function Ageing||Device: Polysomnograph Device: Actiwatch|
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|
|Actual Enrollment :||88 participants|
|Official Title:||Modifiable Health Behaviors Associated With Time-of-Day Differences in Older Adults' Practice-Related Learning|
|Study Start Date :||March 2015|
|Actual Primary Completion Date :||December 2016|
|Actual Study Completion Date :||December 2016|
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 Name: 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 Name: Actiwatch-L, Mini Mitter
- 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
To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT02300272
|United States, Florida|
|University of Florida|
|Gainesville, Florida, United States, 32610|
|Principal Investigator:||Michael E Robinson, Ph.D.||University of Florida|