Sleep Quality, Heart Rate Variability and Anxiety Following Brain Injury

NCT ID: NCT04652895

Last Updated: 2021-12-20

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Total Enrollment

14 participants

Study Classification

OBSERVATIONAL

Study Start Date

2020-12-16

Study Completion Date

2021-06-15

Brief Summary

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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

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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.

Conditions

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Traumatic Brain Injury Anxiety

Keywords

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heart rate variability sleep

Study Design

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Observational Model Type

COHORT

Study Time Perspective

PROSPECTIVE

Study Groups

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Moderate-to-severe traumatic brain injury inpatients

Moderate-to-severe traumatic brain injury inpatients

No interventions assigned to this group

Eligibility Criteria

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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
Minimum Eligible Age

18 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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Shirley Ryan AbilityLab

OTHER

Sponsor Role lead

Responsible Party

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David Ripley

Principle Investigator

Responsibility Role PRINCIPAL_INVESTIGATOR

Locations

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Shirley Ryan Ability Lab

Chicago, Illinois, United States

Site Status

Countries

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United States

Provided Documents

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Document Type: Study Protocol

View Document

Document Type: Informed Consent Form

View Document

Other Identifiers

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STU00212891

Identifier Type: -

Identifier Source: org_study_id