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NCT04652895 Clinical Trial

Sleep Quality, Heart Rate Variability and Anxiety Following Brain Injury

Anxiety Clinical Trial

Official title:
Sleep Quality, Heart Rate Variability and Anxiety Following Brain Injury

Clinical Trial Details — Status: Completed

Administrative data
NCT number NCT04652895
Other study ID # STU00212891
Secondary ID
Status Completed
Phase
First received
Last updated
Start date December 16, 2020
Est. completion date June 15, 2021

Study information
Verified date December 2021
Source Shirley Ryan AbilityLab
Contact n/a
Is FDA regulated No
Health authority
Study type Observational

Clinical Trial 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.

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.

Recruitment information / eligibility
Status Completed
Enrollment 14
Est. completion date June 15, 2021
Est. primary completion date April 15, 2021
Accepts healthy volunteers No
Gender All
Age group 18 Years and older
Eligibility 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

Study Design

Related Conditions & MeSH terms

Locations
Country Name City State
United States Shirley Ryan Ability Lab Chicago Illinois

Sponsors (1)
Lead Sponsor Collaborator
Shirley Ryan AbilityLab

Country where clinical trial is conducted

United States, 

Outcome
Type Measure Description Time frame Safety issue
Primary anxiety self-reported anxiety survey 48 hours
Secondary heart rate variability 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. 48 hours
Secondary sleep 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. 48 hours
Secondary post-traumatic stress disorder (PTSD) self-reported survey of PTSD symptoms 48 hours
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