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Clinical Trials/NCT04652895
NCT04652895
Completed
Not Applicable

Sleep Quality, Heart Rate Variability and Anxiety Following Brain Injury

Shirley Ryan AbilityLab1 site in 1 country14 target enrollmentDecember 16, 2020
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ConditionsTraumatic Brain InjuryAnxiety

Overview

Phase
Not Applicable
Intervention
Not specified
Conditions
Traumatic Brain Injury
Sponsor
Shirley Ryan AbilityLab
Enrollment
14
Locations
1
Primary Endpoint
anxiety
Status
Completed
Last Updated
4 years ago
OverviewInvestigatorsEligibility CriteriaOutcomesSitesSimilar Trials

Overview

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.

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.

Registry
clinicaltrials.gov
Start Date
December 16, 2020
End Date
June 15, 2021
Last Updated
4 years ago
Study Type
Observational
Sex
All

Investigators

Responsible Party
Principal Investigator
Principal Investigator

David Ripley

Principle Investigator

Shirley Ryan AbilityLab

Eligibility 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

Outcomes

Primary Outcomes

anxiety

Time Frame: 48 hours

self-reported anxiety survey

Secondary Outcomes

  • heart rate variability(48 hours)
  • sleep(48 hours)
  • post-traumatic stress disorder (PTSD)(48 hours)

Study Sites (1)

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