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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: Completed NA study, sponsored by University of Kansas Medical Center.
NCT04885205 is a NA study that has completed, run by University of Kansas Medical Center. The registered enrollment target is 40 participants, below the 1,404-participant average among 58,714 other NA trials with a reported enrollment target (97% lower). According to ClinicalTrials.gov, the official US trial registry.
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.
Primary Outcome
7 questions each rated on a 0-4 scale. The range of scores on the ISI is 0-28
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 |
What the finished NCT04885205 record still lists
NCT04885205 is an interventional study that assigns participants to a tested intervention. The registry caps enrollment at 40 participants, a relatively small participant target, below the 1,404-participant average among 58,714 other NA trials with a reported enrollment target (97% lower).
The record links to 0 conditions, and to 1 intervention - of which cognitive behavioral therapy for insomnia (CBT-I) is the first listed.
NCT04885205 does not publish any study locations in the registry export this page uses.
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.
Learn More About Clinical Trials
How this trial's enrollment target compares
Where NCT04885205's enrollment target sits among peer trials
40 1447th of 2000 higher than 465 of 2,000 other NA trials
participants (enrollment target), bucketed by value
Each bar is a band; taller bars hold more other NA trials. The dashed line + filled bar mark this entry. Hover or tap any bar for its full count and share, and where it sits relative to this entry.
Source ClinicalTrials.gov registry export · 2026-08-08
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