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Sleep Quality, Heart Rate Variability and Anxiety Following Brain Injury

Sponsor
Shirley Ryan AbilityLab (Other)
Overall Status
Completed
CT.gov ID
NCT04652895
Collaborator
(none)
14
Enrollment
1
Location
5.9
Actual Duration (Months)
2.4
Patients Per Site Per Month

Study Details

Study Description

Brief Summary

The investigators predict that decreased heart rate variability and poor sleep quality will be significantly correlated with higher self-reported anxiety following brain injury.

Condition or Disease Intervention/Treatment Phase

    Detailed Description

    Acute rehabilitation inpatients with moderate-to-severe brain injury will wear biosensors that track total sleep time and heart-rate variability for up to 1 week. During this time the participants will also complete surveys regarding symptoms of anxiety. The investigators hypothesize that decreased heart rate variability and poor sleep quality will be significantly correlated with higher self-reported anxiety following brain injury.

    Study Design

    Study Type:
    Observational
    Actual Enrollment :
    14 participants
    Observational Model:
    Cohort
    Time Perspective:
    Prospective
    Official Title:
    Sleep Quality, Heart Rate Variability and Anxiety Following Brain Injury
    Actual Study Start Date :
    Dec 16, 2020
    Actual Primary Completion Date :
    Apr 15, 2021
    Actual Study Completion Date :
    Jun 15, 2021

    Arms and Interventions

    Arm Intervention/Treatment
    Moderate-to-severe traumatic brain injury inpatients

    Moderate-to-severe traumatic brain injury inpatients

    Outcome Measures

    Primary Outcome Measures

    1. anxiety [48 hours]

      self-reported anxiety survey

    Secondary Outcome Measures

    1. heart rate variability [48 hours]

      Skin biosensor on patient chest, measuring heart rate over 6 minute interval while patient is awake and resting. Then heart rate variability is calculated based on the R-R interval.

    2. sleep [48 hours]

      self-reported sleep survey. Also skin biosensor measuring heart rate and accelerometer overnight for 2 consecutive nights. Total sleep time and awakening episodes will be derived from the biosensor data.

    3. post-traumatic stress disorder (PTSD) [48 hours]

      self-reported survey of PTSD symptoms

    Eligibility Criteria

    Criteria

    Ages Eligible for Study:
    18 Years and Older
    Sexes Eligible for Study:
    All
    Accepts Healthy Volunteers:
    No
    Inclusion Criteria:

    • traumatic brain injury

    • injury within past 6 months

    • medically stable

    • able to communicate

    Exclusion Criteria:

    • on medication: beta-blocker

    • adverse skin reaction to biosensor adhesive

    • non-English speaking

    • pregnant women

    • prisoners

    Contacts and Locations

    Locations

    Site City State Country Postal Code
    1 Shirley Ryan Ability Lab Chicago Illinois United States 60611

    Sponsors and Collaborators

    • Shirley Ryan AbilityLab

    Investigators

    None specified.

    Study Documents (Full-Text)

    More Information

    Publications

    None provided.
    Responsible Party:
    David Ripley, Principle Investigator, Shirley Ryan AbilityLab
    ClinicalTrials.gov Identifier:
    NCT04652895
    Other Study ID Numbers:
    • STU00212891
    First Posted:
    Dec 3, 2020
    Last Update Posted:
    Dec 20, 2021
    Last Verified:
    Dec 1, 2021
    Studies a U.S. FDA-regulated Drug Product:
    No
    Studies a U.S. FDA-regulated Device Product:
    No
    Keywords provided by David Ripley, Principle Investigator, Shirley Ryan AbilityLab
    heart rate variability
    sleep
    Additional relevant MeSH terms:
    Brain Injuries
    Brain Injuries, Traumatic
    Wounds and Injuries
    Anxiety Disorders

    Study Results

    No Results Posted as of Dec 20, 2021