Alteration of Cognitive FunctionOA-TIMENCT02300272
Health Behaviors and Time-of-Day: Older Adult Cognitive Function
An observational study of Alteration of Cognitive Function and Ageing, run by University of Florida at 1 site in United States.
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. Read more about this study
- Who is it for?
- Ages 65 years and olderHealthy volunteers can take part
- Conditions the study is for
- Alteration of Cognitive Function, Ageing
- What is being tested?
- Polysomnograph and Actiwatch
- Type of treatment
- Pill or oral medicine, Medical device
- How many people
- 88 participants
- Where
- 1 siteUnited States
- Study dates
- Mar 2015to Dec 2016
- Phase
- Observational
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 65 years and older
- All sexes
- Healthy volunteers accepted
- Older adult
Study population: Typically, healthy older adults
Who may be able to join
- Age of 65 years and older
- Able to read and speak English
- Completion of Morningness-Eveningness Questionnaire
Who cannot join
- 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
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Modifiable Health Behaviors Associated With Time-of-Day Differences in Older Adults' Practice-Related Learning
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.
Read the 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.
- Conditions
- Alteration of Cognitive Function, Ageing
- Being tested
- Polysomnograph, Actiwatch
- Keywords
- Practice-related learning, Sleep, Pain, Circadian Rhythm, Older Adults
- Medical subject headings
- Pain
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
PolysomnographDevice
Also called AURA Recording System, Grass Technologies
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.
ActiwatchDevice
Also called Actiwatch-L, Mini Mitter
This device will be worn on the wrist for 14 continuous days to measure limb movements and ambient light.
| Study group | Role | What they receive |
|---|---|---|
| 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. Receives: Device: Polysomnograph; Device: Actiwatch |
What is being measured
The primary outcome is the main question the study is designed to answer.
Cognition as assessed by computerized neuropsychological testing
Cognitive domains include processing speed, immediate memory, delayed memory, and executive function
Measured: Morning and evening completion for 14 days
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted24 Nov 2014 (estimated)
- Study startMar 2015
- Primary completionDec 2016
- Study completionDec 2016
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Alteration of Cognitive FunctionStudies of the same condition, open and under way.
- More trials run by University of FloridaThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Cohort
- Time perspective
- Prospective
- Enrolment
- 88 participants (actual)
Sponsor and investigators
- Lead sponsor
- University of Florida
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Michael E Robinson, Ph.D., Principal investigator, University of Florida
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02300272
- Sponsor's protocol ID
- IRB201400910
- Acronym
- OA-TIME
- Status last verified
- Dec 2019
- First submitted
- 20 Nov 2014
- Last updated
- 13 Dec 2019
- Results posted
- No
- Data monitoring committee
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 13 Dec 2019. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Modifiable Health Behaviors Associated With Time-of-Day Differences in Older Adults' Practice-Related Learning
- ClinicalTrials.gov ID
- NCT02300272
- Acronym / sponsor ID
- OA-TIME / IRB201400910
- Conditions
- Alteration of Cognitive Function, Ageing
- Keywords
- Practice-related learning, Sleep, Pain, Circadian Rhythm, Older Adults
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 88 participants (actual)
- Lead sponsor
- University of FloridaUniversity, hospital or other
- Study start
- Mar 2015
- Primary completion
- Dec 2016 (actual)
- Study completion
- Dec 2016 (actual)
- First posted
- 24 Nov 2014 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
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 design
- Observational model
- Cohort
- Time perspective
- Prospective
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Typically healthy older adults | – | Device: Polysomnograph, Device: ActiwatchAdults 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. |
Who may qualify
- Ages
- 65 years and older
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Older adult
- Study population
- Typically, healthy older adults
Key inclusion criteria (3 listed)
- Age of 65 years and older
- Able to read and speak English
- Completion of Morningness-Eveningness Questionnaire
Key exclusion criteria (7 listed)
- Significant medical or neurological disorder
- Major psychopathology
- Pain disorder other than fibromyalgia or osteoarthritis
- Sleep disorder other than insomnia
- Cognitive impairment
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| PolysomnographAlso: AURA Recording System, Grass TechnologiesParticipants 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. | Device | Typically healthy older adults |
| ActiwatchAlso: Actiwatch-L, Mini MitterThis device will be worn on the wrist for 14 continuous days to measure limb movements and ambient light. | Device | Typically healthy older adults |
Primary outcome
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
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 13 Dec 2019.
- Individual participant dataSharing planned: No
Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Michael E Robinson, Ph.D. principal investigator
University of Florida
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Alteration of Cognitive Function and Ageing, run by University of Florida at 1 site in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 3 inclusion and 7 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 13 Dec 2019. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Cognition as assessed by computerized neuropsychological testing (time frame: Morning and evening completion for 14 days). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 13 Dec 2019; AzTrials last refreshed its copy on 8 Nov 2026.