Ignite Creation Date:
2025-12-24 @ 1:43 PM
Ignite Modification Date:
2025-12-30 @ 7:03 PM
Study NCT ID:
NCT04652895
Status:
COMPLETED
Last Update Posted:
2021-12-20
First Post:
2020-10-16
Is Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Sleep Quality, Heart Rate Variability and Anxiety Following Brain Injury
Sponsor:
Shirley Ryan AbilityLab
Organization:
Study Overview
Official Title:
Sleep Quality, Heart Rate Variability and Anxiety Following Brain Injury
Status:
COMPLETED
Status Verified Date:
2021-12
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
Not Stopped
Has Expanded Access:
False
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
None
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 Oversight
Has Oversight DMC:
False
Is a FDA Regulated Drug?:
False
Is a FDA Regulated Device?:
False
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
None
Is an FDA AA801 Violation?: