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Completed

NCT Number: NCT04652895

Sleep Quality, Heart Rate Variability and Anxiety Following Brain Injury

The investigators predict 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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Key information

Conditions

Traumatic Brain Injury Anxiety Anxiety Disorders Brain Diseases Brain Injuries Brain Injuries, Traumatic Central Nervous System Diseases Craniocerebral Trauma Mental Disorders Nervous System Diseases Trauma, Nervous System Wounds and Injuries

Age range

18 year and older

Sex eligibility

All sexes

Study type

Observational

Primary location

Shirley Ryan Ability Lab

Chicago, Illinois, 60611, United States

About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Primary outcomes

  1. anxiety

    Time frame: 48 hours

    self-reported anxiety survey

Secondary outcomes

  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

Sponsors and collaborators

Lead sponsor

Shirley Ryan AbilityLab

Other

Registry information

Important dates

Study start
2020
Primary completion
2021
Study completion
2021
First posted
Dec 3, 2020
Registry last updated
Dec 20, 2021

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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