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NCT05173818 · ClinicalTrials.gov registry record · Phase 2
Hyperbaric Oxygen Effects on Persistent Post-concussive Symptoms
A Phase 2 study, sponsored by Essentia Health.
- Completed
- Registry status
- Phase 2
- Development phase
- 20
- Enrollment target
NCT05173818: Completed Phase 2 study, sponsored by Essentia Health.
NCT05173818 is a Phase 2 study that has completed, run by Essentia Health. The registered enrollment target is 20 participants, below the 133-participant average among 30,622 other Phase 2 trials with a reported enrollment target (85% lower). According to ClinicalTrials.gov, the official US trial registry.
The verdict
NCT05173818, a Phase 2 study, has completed, sponsored by Essentia Health.
- COMPLETED
- Registry status
- Phase 2
- Development phase
- 20 participants
- Enrollment target
Study Summary
Persistent post-concussive symptoms (PPCS) are a source of significant burden among a subset of patients with concussion with prevalence rates previously reported between 11 - 82% based on timing of assessment, diagnostic criteria, or population under study. Examples of persistent post-concussion symptoms include balance problems, headaches, fatigue, poor concentration, forgetfulness, anxiety, irritability, and sleep disturbance. Few proposed therapies have proved successful in the management of persistent post-concussion symptoms following mild traumatic brain injury. The investigators will explore hyperbaric oxygen administered in a randomized sham-controlled clinical trial as an effective and tolerable treatment in improving neuropsychological status among adult patients with persistent post-concussive symptoms. The overall hypothesis to be evaluated is that hyperbaric oxygen improves neuropsychological status and a serum concussion biomarker associated with PPCS.
Primary Outcome
This is a validated screening tool initially used to assess dementia but has been extended to other neuropsychological conditions, including mild traumatic brain injury. RBANS can assess a broad range of independent neuropsychological domains, a characteristic of mild traumatic brain injury (affects different domains such as sleep, cognition). Alternate forms of RBANS allow for repeated evaluation and sensitivity to milder brain impairment.
Interventions
- DRUG Sham treatment
- DRUG Hyperbaric oxygen at 1.5 ATA
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 20 participants |
| Start Date | 2022-06-28 |
| Est. Completion | 2025-08-01 |
| Phase | Phase 2 |
What the finished NCT05173818 record still lists
NCT05173818 is an interventional study that assigns participants to a tested intervention. The registry caps enrollment at 20 participants, a relatively small participant target, below the 133-participant average among 30,622 other Phase 2 trials with a reported enrollment target (85% lower).
The record links to 0 conditions, and to 2 interventions - of which Sham treatment is the first listed.
NCT05173818 does not publish any study locations in the registry export this page uses.
Frequently Asked Questions
What is clinical trial NCT05173818 about?
NCT05173818 is a clinical study titled "Hyperbaric Oxygen Effects on Persistent Post-concussive Symptoms". Persistent post-concussive symptoms (PPCS) are a source of significant burden among a subset of patients with concussion with prevalence rates previously reported between 11 - 82% based on timing of assessment, diagnostic criteria, or population under study. Examples of persistent post-concussion s...
What is the current status of trial NCT05173818?
This trial is currently completed. It is a Phase 2 study. The enrollment target is 20 participants. The study started on 2022-06-28. Estimated completion is 2025-08-01.
What interventions are being tested in trial NCT05173818?
The interventions under investigation include: Sham treatment (DRUG), Hyperbaric oxygen at 1.5 ATA (DRUG).
Who is sponsoring clinical trial NCT05173818?
This trial is sponsored by Essentia Health, which has 17 total clinical trials registered on ClinicalTrials.gov.
Learn More About Clinical Trials
How this trial's enrollment target compares
Where NCT05173818's enrollment target sits among peer trials
20 1805th of 2000 higher than 107 of 2,000 other Phase 2 trials
participants (enrollment target), bucketed by value
Each bar is a band; taller bars hold more other Phase 2 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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