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Sleep Quality, Heart Rate Variability and Anxiety Following Brain Injury

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Know the risks and potential benefits of clinical studies and talk to your health care provider before participating. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT04652895
Recruitment Status : Recruiting
First Posted : December 3, 2020
Last Update Posted : December 19, 2020
Sponsor:
Information provided by (Responsible Party):
David Ripley, Shirley Ryan AbilityLab

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
Traumatic Brain Injury Anxiety

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.

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Study Type : Observational
Estimated Enrollment : 100 participants
Observational Model: Cohort
Time Perspective: Prospective
Official Title: Sleep Quality, Heart Rate Variability and Anxiety Following Brain Injury
Actual Study Start Date : December 16, 2020
Estimated Primary Completion Date : March 15, 2021
Estimated Study Completion Date : June 15, 2021

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Anxiety

Group/Cohort
Moderate-to-severe traumatic brain injury inpatients
Moderate-to-severe traumatic brain injury inpatients



Primary Outcome Measures :
  1. anxiety [ Time Frame: 48 hours ]
    self-reported anxiety survey


Secondary Outcome Measures :
  1. heart rate variability [ Time Frame: 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 [ Time Frame: 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) [ Time Frame: 48 hours ]
    self-reported survey of PTSD symptoms



Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Sampling Method:   Probability Sample
Study Population
moderate to severe traumatic brain injury inpatients in acute rehabilitation hospital
Criteria

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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT04652895


Contacts
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Contact: Jamie L Ott, DO 847-703-0503 jott@sralab.org
Contact: David L Ripley, MD 312-238-2091 dripley@sralab.org

Locations
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United States, Illinois
Shirley Ryan Ability Lab Recruiting
Chicago, Illinois, United States, 60611
Contact: Jamie Ott, DO    312-600-7391    jott@sralab.org   
Contact: David Ripley, MD    312-238-1000    dripley@ric.org   
Sponsors and Collaborators
Shirley Ryan AbilityLab
  Study Documents (Full-Text)

Documents provided by David Ripley, Shirley Ryan AbilityLab:
Study Protocol  [PDF] August 24, 2020
Informed Consent Form  [PDF] September 11, 2020

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Responsible Party: David Ripley, Principle Investigator, Shirley Ryan AbilityLab
ClinicalTrials.gov Identifier: NCT04652895    
Other Study ID Numbers: STU00212891
First Posted: December 3, 2020    Key Record Dates
Last Update Posted: December 19, 2020
Last Verified: December 2020

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
Keywords provided by David Ripley, Shirley Ryan AbilityLab:
heart rate variability
sleep
Additional relevant MeSH terms:
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Brain Injuries
Brain Injuries, Traumatic
Wounds and Injuries
Anxiety Disorders
Mental Disorders
Brain Diseases
Central Nervous System Diseases
Nervous System Diseases
Craniocerebral Trauma
Trauma, Nervous System