Sleep Quality, Heart Rate Variability and Anxiety Following Brain Injury

Status

Completed

Phases

Unknown

Study type

Observational

Source

ClinicalTrials.gov

Registry ID

NCT04652895

Enrollment

Registered

2020-12-03

Start date

2020-12-16

Completion date

2021-06-15

Last updated

2021-12-20

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Anxiety, Traumatic Brain Injury

Keywords

heart rate variability, sleep

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.

Interventions

None listed

Study design

Observational model

COHORT

Time perspective

PROSPECTIVE

Eligibility

Sex/Gender

ALL

Age

18 Years to No maximum

Healthy volunteers

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

Design outcomes

Primary

Measure	Time frame	Description
anxiety	48 hours	self-reported anxiety survey

Secondary

Measure	Time frame	Description
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

Countries

United States

Outcome results