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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 is a Phase 2 study that has completed, run by Essentia Health. The registered enrollment target is 20 participants.

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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.

Interventions

  • DRUG Sham treatment
  • DRUG Hyperbaric oxygen at 1.5 ATA

Trial Details

FieldValue
Enrollment Target 20 participants
Start Date 2022-06-28
Est. Completion 2025-08-01
Phase Phase 2

Sponsor

Essentia Health

17 total trials

What the Registry Record Tells You About NCT05173818

The ClinicalTrials.gov registry entry for NCT05173818 describes a study currently listed as completed, categorized as Phase 2. The registered enrollment target is 20 participants, a figure that helps gauge the scale of data the investigators plan to collect. The listed sponsor is Essentia Health, which has 17 total studies on file at ClinicalTrials.gov.

The record links to 0 conditions, and to 2 interventions - of which Sham treatment is the first listed.

NCT05173818 reports 0 study locations.

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.

Data sourced from official public datasets. See our methodology for details. Retrieved and formatted by PlainTrial Editorial

Every figure on PlainTrial is rendered directly from the ClinicalTrials.gov registry, no number is typed in by an editor. This page mirrors this trial's own ClinicalTrials.gov registry record, live from the dataset. See our editorial standards & corrections policy, the methodology behind these numbers, or report a data error.