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

Ageing Clinical Trial

— OA-TIME  

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT02300272
• Other study ID #: IRB201400910
• Status: Completed
• Start date: March 2015
• Est. completion date: December 2016

Study information

• Verified date: December 2019
• Source: University of Florida
• Contact: n/a
• Is FDA regulated: No
• Study type: Observational

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 88
• Est. completion date: December 2016
• Est. primary completion date: December 2016
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: All
• Age group: 65 Years and older

Eligibility

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

Related Conditions & MeSH terms

• Ageing
• Alteration of Cognitive Function

Intervention

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.
• Actiwatch
This device will be worn on the wrist for 14 continuous days to measure limb movements and ambient light.

Locations

Country	Name	City	State
United States	University of Florida	Gainesville	Florida

Sponsors (1)

Lead Sponsor	Collaborator
University of Florida

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Cognition as assessed by computerized neuropsychological testing	Cognitive domains include processing speed, immediate memory, delayed memory, and executive function	Morning and evening completion for 14 days