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NCT04885205 · ClinicalTrials.gov registry record · NA
Use of CBT-I in Individuals With a Concussion
A NA study, sponsored by University of Kansas Medical Center.
- Completed
- Registry status
- NA
- Development phase
- 40
- Enrollment target
NCT04885205 is a NA study that has completed, run by University of Kansas Medical Center. The registered enrollment target is 40 participants.
The verdict
NCT04885205, a NA study, has completed, sponsored by University of Kansas Medical Center.
- COMPLETED
- Registry status
- NA
- Development phase
- 40 participants
- Enrollment target
Study Summary
Sleep disturbances have been shown to contribute to poorer recovery from a concussion. Furthermore, sleep disturbances have been associated with more frequent and severe post-concussion symptoms including headache, vertigo, anxiety, depression, and decreased short term memory reducing quality of life and productivity at work or school. Additionally, recent research indicates that individuals with a concussion who have poor sleep quality have increased levels of Neurofilament light (NfL) and tau biomarkers indicating that there may still be axonal damage after weeks or months after the initial concussion injury. Post-concussion symptoms have been associated with higher levels of these biomarkers and there has been a report of higher levels of NfL and tau years following a concussion event. Cognitive behavioral therapy for insomnia (CBT-I) is an effective treatment for insomnia yet it remains unclear if this treatment method is effective in improving sleep outcomes, reducing concomitant post-concussion symptoms, and biomarkers of neural injury/risk in individuals post- concussion. The central hypothesis for this project is treating sleep disturbances will yield a clinically relevant reduction in concomitant post-concussion symptoms. The objective for the proposed study is to determine if CBT-I will reduce insomnia symptoms and improve concomitant post-concussion symptoms in individuals after concussion and if symptom improvements are maintained at 6-weeks and 12-weeks after CBT-I intervention.
Interventions
- BEHAVIORAL cognitive behavioral therapy for insomnia (CBT-I)
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 40 participants |
| Start Date | 2021-04-30 |
| Est. Completion | 2022-12-02 |
| Phase | NA |
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Full Details on ClinicalTrials.gov ↗What the Registry Record Tells You About NCT04885205
The ClinicalTrials.gov registry entry for NCT04885205 describes a study currently listed as completed, categorized as NA. The registered enrollment target is 40 participants, a figure that helps gauge the scale of data the investigators plan to collect. The listed sponsor is University of Kansas Medical Center, which has 408 total studies on file at ClinicalTrials.gov.
The record links to 0 conditions, and to 1 intervention - of which cognitive behavioral therapy for insomnia (CBT-I) is the first listed.
NCT04885205 reports 0 study locations.
Frequently Asked Questions
What is clinical trial NCT04885205 about?
NCT04885205 is a clinical study titled "Use of CBT-I in Individuals With a Concussion". Sleep disturbances have been shown to contribute to poorer recovery from a concussion. Furthermore, sleep disturbances have been associated with more frequent and severe post-concussion symptoms including headache, vertigo, anxiety, depression, and decreased short term memory reducing quality of lif...
What is the current status of trial NCT04885205?
This trial is currently completed. It is a NA study. The enrollment target is 40 participants. The study started on 2021-04-30. Estimated completion is 2022-12-02.
What interventions are being tested in trial NCT04885205?
The interventions under investigation include: cognitive behavioral therapy for insomnia (CBT-I) (BEHAVIORAL).
Who is sponsoring clinical trial NCT04885205?
This trial is sponsored by University of Kansas Medical Center, which has 408 total clinical trials registered on ClinicalTrials.gov.
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