Sleep Quality, Heart Rate Variability and Anxiety Following Brain Injury

Completed

• Conditions: Traumatic Brain Injury; Anxiety

• Registration Number: NCT04652895
• Lead Sponsor: 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.

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 Timeline

• Study First Submitted: 2020-10-16
• Study First Submitted QC: 2020-12-02
• Study First Posted: 2020-12-03
• Study Start: 2020-12-16
• Primary Completion: 2021-04-15
• Study Completion: 2021-06-15
• Status Verified: 2021-12
• Last Update Submitted: 2021-12-17
• Last Update Posted: 2021-12-20

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 14

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

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
anxiety	48 hours	self-reported anxiety survey

Secondary Outcome Measures

Name	Time	Method
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.
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.
post-traumatic stress disorder (PTSD)	48 hours	self-reported survey of PTSD symptoms

Trial Locations

Locations (1)

Shirley Ryan Ability Lab; 🇺🇸 Chicago, Illinois, United States