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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
Sponsor:
Information provided by (Responsible Party):
University of Florida

Brief Summary:
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.

Condition or disease Intervention/treatment
Alteration of Cognitive Function Ageing Device: Polysomnograph Device: Actiwatch

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.


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Study Type : Observational
Actual Enrollment : 88 participants
Observational Model: Cohort
Time Perspective: Prospective
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

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.
Device: Polysomnograph
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

Device: Actiwatch
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




Primary Outcome Measures :
  1. 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



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Ages Eligible for Study:   65 Years and older   (Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   Yes
Sampling Method:   Probability Sample
Study Population
Typically, healthy older adults
Criteria

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

Information from the National Library of Medicine

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


Locations
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United States, Florida
University of Florida
Gainesville, Florida, United States, 32610
Sponsors and Collaborators
University of Florida
Investigators
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Principal Investigator: Michael E Robinson, Ph.D. University of Florida

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Responsible Party: University of Florida
ClinicalTrials.gov Identifier: NCT02300272     History of Changes
Other Study ID Numbers: IRB201400910
First Posted: November 24, 2014    Key Record Dates
Last Update Posted: December 26, 2016
Last Verified: December 2016
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No

Keywords provided by University of Florida:
Practice-related learning
Sleep
Pain
Circadian Rhythm
Older Adults