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OpenTrials
Completed

NCT Number: NCT02300272

Health Behaviors and Time-of-Day: Older Adult Cognitive Function

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.

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Key information

Age range

65 year and older

Sex eligibility

All sexes

Study type

Observational

Primary location

University of Florida

Gainesville, Florida, 32610, United States

About this study

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.

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Polysomnograph

Device

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

Actiwatch

Device

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

Primary outcomes

  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

Sponsors and collaborators

Lead sponsor

University of Florida

Other

Registry information

Official study title

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

Acronym: OA-TIME

Important dates

Study start
2015
Primary completion
2016
Study completion
2016
First posted
Nov 24, 2014
Registry last updated
Dec 13, 2019

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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