Sleep Quality, Heart Rate Variability and Anxiety Followi... | NCT04652895

Studies
Sleep Quality, Heart Rate Variability and Anxiety Following Brain Injury

NCT04652895

Sponsor

Shirley Ryan AbilityLab

Status

Completed

Last Update Posted

Dec 20, 2021Actual

Enrollment

14Actual

Phase

Not provided

Conditions

Traumatic Brain Injury
Anxiety

Interventions

Not provided

Countries

United States

Protocol Section

Identification Module Status Module Sponsor/Collaborators Module Oversight Module Description Module Conditions Module Design Module Arms/Interventions Module Outcomes Module Eligibility Module Contacts/Locations Module References Module IPD Sharing Statement Module

Results Section

Participant Flow Module Baseline Characteristics Module Outcome Measures Module Adverse Events Module More Info Module

Annotation Section

Annotation Module

Document Section

Large Document Module

Derived Section

Miscellaneous Info Module Condition Browse Module Intervention Browse Module

Protocol Section

Identification Module

NCT ID

Results Section

No data available

No data is available for this block.

Annotation Section

No data available

No data is available for this block.

Document Section

Large Document Module

Document Has No Statistical Analysis Plan (SAP)

Derived Section

Miscellaneous Info Module

Version Holder

Status Module

Record Verification Date

Dec 2021

Overall Recruitment Status or Expanded Access Status

Completed

Last Known Status

Not provided

Delayed Posting

Not provided

Why Stopped

Not provided

Expanded Access Info

Start Date

Dec 16, 2020Actual

Primary Completion Date

Apr 15, 2021Actual

Completion Date

Jun 15, 2021Actual

First Submitted Date

Oct 16, 2020

First Submission Date that Met QC Criteria

Dec 2, 2020

First Posted Date

Dec 3, 2020Actual

Results Waived

Not provided

Results First Submitted Date

Not provided

Results First Submitted that Met QC Criteria

Not provided

Results First Posted Date

Not provided

Certification/Extension (aka Delayed Results) First Submitted Date

Not provided

Certification/Extension First Submitted that Passed QC Review

Not provided

Certification/Extension First Posted Date

Not provided

Last Update Submitted Date

Dec 17, 2021

Last Update Posted Date

Dec 20, 2021Actual

Oversight Module

Has Data Monitoring Committee (DMC)

Is FDA Regulated Drug

Is FDA Regulated Device

Is Unapproved Device

Not provided

Pediatric Postmarket Surveillance of a Device Product

Not provided

Product Exported from US

Not provided

FDAAA801 Violation

Not provided

Description Module

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.

Design Module

Study Type

Observational

Number of References to an Expanded Access Study

Not provided

Expanded Access Types

Not provided

Patient Registry

Target Follow-Up Duration

Not provided

Phases

Not provided

Interventional Study Design

Allocation

Not provided

Intervention Model

Biospecimen

No data available

No data is available for this block.

Enrollment

14Actual

Arms/Interventions Module

Arm Groups

Label	Type	Description	Intervention Names
Moderate-to-severe traumatic brain injury inpatients		Moderate-to-severe traumatic brain injury inpatients

Interventions

Not provided

Outcomes Module

Primary Outcomes

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

Secondary Outcomes

Measure	Description	Time Frame
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
sleep

Other Outcomes

Not provided

Eligibility Module

Eligibility Criteria

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

Accepts Healthy Volunteers

Sex

All

Sex/Gender Based

Not provided

Sex/Gender Description

Not provided

Minimum Age

18 Years

Maximum Age

Not provided

Standard Ages

AdultOlder Adult

Study Population

moderate to severe traumatic brain injury inpatients in acute rehabilitation hospital

Sampling Method

Probability Sample

Contacts/Locations Module

Central Contacts

Not provided

Overall Officials

Not provided

Locations

Facility	Status	City	State	ZIP	Country	Contacts
Shirley Ryan Ability Lab		Chicago	Illinois	60611	United States

Uploaded Document Information

Type	Includes Protocol	Includes SAP	Includes ICF	Document Label	Document Date	Document Uploaded Date	Document File Name
Prot	Yes	No	No	Study Protocol	Aug 24, 2020	Sep 29, 2020	Prot_000.pdf
ICF	No	No	Yes	Informed Consent Form	Sep 11, 2020	Sep 29, 2020	ICF_001.pdf

Condition Browse Module

MeSH Terms

ID	Term
D000070642	Brain Injuries, Traumatic
D001008	Anxiety Disorders

Ancestor Terms

ID	Term
D001930	Brain Injuries
D001927	Brain Diseases
D002493	Central Nervous System Diseases
D009422	Nervous System Diseases

Browse Leaves

Not provided

Browse Branches

Not provided