NCT02300272

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.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
88

participants targeted

Target at P50-P75 for all trials

Timeline
Completed

Started Mar 2015

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

November 20, 2014

Completed
4 days until next milestone

First Posted

Study publicly available on registry

November 24, 2014

Completed
3 months until next milestone

Study Start

First participant enrolled

March 1, 2015

Completed
1.8 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

December 1, 2016

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

December 1, 2016

Completed
Last Updated

December 13, 2019

Status Verified

December 1, 2019

Enrollment Period

1.8 years

First QC Date

November 20, 2014

Last Update Submit

December 12, 2019

Conditions

Keywords

Practice-related learningSleepPainCircadian RhythmOlder Adults

Outcome Measures

Primary Outcomes (1)

  • 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

Study Arms (1)

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: PolysomnographDevice: Actiwatch

Interventions

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.

Also known as: AURA Recording System, Grass Technologies
Typically healthy older adults
ActiwatchDEVICE

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

Also known as: Actiwatch-L, Mini Mitter
Typically healthy older adults

Eligibility Criteria

Age65 Years+
Sexall
Healthy VolunteersYes
Age GroupsOlder Adult (65+)
Sampling MethodProbability Sample
Study Population

Typically, healthy older adults

You may qualify if:

  • Age of 65 years and older
  • Able to read and speak English
  • Completion of Morningness-Eveningness Questionnaire

You may not qualify if:

  • 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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

University of Florida

Gainesville, Florida, 32610, United States

Location

MeSH Terms

Conditions

Pain

Condition Hierarchy (Ancestors)

Neurologic ManifestationsSigns and SymptomsPathological Conditions, Signs and Symptoms

Study Officials

  • Michael E Robinson, Ph.D.

    University of Florida

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
observational
Observational Model
COHORT
Time Perspective
PROSPECTIVE
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

November 20, 2014

First Posted

November 24, 2014

Study Start

March 1, 2015

Primary Completion

December 1, 2016

Study Completion

December 1, 2016

Last Updated

December 13, 2019

Record last verified: 2019-12

Data Sharing

IPD Sharing
Will not share

Locations