Traumatic Brain InjuryNCT04652895
Sleep Quality, Heart Rate Variability and Anxiety Following Brain Injury
An observational study of Traumatic Brain Injury and Anxiety, run by Shirley Ryan AbilityLab at 1 site in United States.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Traumatic Brain Injury, Anxiety
- How many people
- 14 participants
- Where
- 1 siteUnited States
- Study dates
- 16 Dec 2020to 15 Jun 2021
- Phase
- Observational
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Study population: moderate to severe traumatic brain injury inpatients in acute rehabilitation hospital
Who may be able to join
- traumatic brain injury
- injury within past 6 months
- medically stable
- able to communicate
Who cannot join
- on medication: beta-blocker
- adverse skin reaction to biosensor adhesive
- non-English speaking
- pregnant women
- prisoners
Trial locations and contacts
1 site in 1 country.
About this study
The investigators predict that decreased heart rate variability and poor sleep quality will be significantly correlated with higher self-reported anxiety following brain injury.
Read the 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.
- Conditions
- Traumatic Brain Injury, Anxiety
- Keywords
- heart rate variability, sleep
- Medical subject headings
- Brain Injuries, Traumatic, Anxiety Disorders
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
| Study group | Role | What they receive |
|---|---|---|
| Moderate-to-severe traumatic brain injury inpatients | Moderate-to-severe traumatic brain injury inpatients |
What is being measured
The primary outcome is the main question the study is designed to answer.
anxiety
self-reported anxiety survey
Measured: 48 hours
Secondary outcomes (3)
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.
Measured: 48 hours
sleep
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.
Measured: 48 hours
post-traumatic stress disorder (PTSD)
self-reported survey of PTSD symptoms
Measured: 48 hours
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted3 Dec 2020
- Study start16 Dec 2020
- Primary completion15 Apr 2021
- Study completion15 Jun 2021
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Traumatic Brain InjuryStudies of the same condition, open and under way.
- More trials run by Shirley Ryan AbilityLabThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Cohort
- Time perspective
- Prospective
- Enrolment
- 14 participants (actual)
Sponsor and investigators
- Lead sponsor
- Shirley Ryan AbilityLab
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, David Ripley, Shirley Ryan AbilityLab
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04652895
- Sponsor's protocol ID
- STU00212891
- Status last verified
- Dec 2021
- First submitted
- 16 Oct 2020
- Last updated
- 20 Dec 2021
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 20 Dec 2021. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Sleep Quality, Heart Rate Variability and Anxiety Following Brain Injury
- ClinicalTrials.gov ID
- NCT04652895
- Acronym / sponsor ID
- STU00212891
- Conditions
- Traumatic Brain Injury, Anxiety
- Keywords
- heart rate variability, sleep
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 14 participants (actual)
- Lead sponsor
- Shirley Ryan AbilityLabUniversity, hospital or other
- Study start
- 16 Dec 2020 (actual)
- Primary completion
- 15 Apr 2021 (actual)
- Study completion
- 15 Jun 2021 (actual)
- First posted
- 3 Dec 2020 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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 design
- Observational model
- Cohort
- Time perspective
- Prospective
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Moderate-to-severe traumatic brain injury inpatients | – | –Moderate-to-severe traumatic brain injury inpatients |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- moderate to severe traumatic brain injury inpatients in acute rehabilitation hospital
Key inclusion criteria (4 listed)
- traumatic brain injury
- injury within past 6 months
- medically stable
- able to communicate
Key exclusion criteria (5 listed)
- on medication: beta-blocker
- adverse skin reaction to biosensor adhesive
- non-English speaking
- pregnant women
- prisoners
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Primary outcome
anxiety
Time frame: 48 hours
self-reported anxiety survey
3 secondary outcomes
heart rate variability
Time frame: 48 hours
sleep
Time frame: 48 hours
post-traumatic stress disorder (PTSD)
Time frame: 48 hours
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 20 Dec 2021.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
The record lists no contact. Use the official record to reach the sponsor.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Traumatic Brain Injury and Anxiety, run by Shirley Ryan AbilityLab at 1 site in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 4 inclusion and 5 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 20 Dec 2021. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
anxiety (time frame: 48 hours). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 20 Dec 2021.