Outcomes From Hyperbaric Oxygen (HBO2) Treatment for Emerging Indications

NCT07240649 | Not Yet Recruiting Phase 4 FDA Drug FDA Device

• 1 other identifier: STUDY02003096
• Study Type: interventional
• Target: 100
• Locations: 0 countries
• Sites: N/A

Brief Summary

This study will evaluate the effectiveness of hyperbaric oxygen therapy (HBOT) on treating emerging indications (i.e., conditions that have shown to potentially benefit from HBOT) using the Multicenter Registry for Hyperbaric Oxygen Treatment. The study team aims to collect ongoing data on how well HBOT treats these emerging indications, and to add these data to the growing HBO Registry. The research team hypothesizes that HBOT will result in improvements of the condition of the various emerging indications.

Conditions

Calciphylaxis; Frostbite; Acute COVID-19; Pyoderma Gangrenosum; Pterygium; Hypospadias; Head Trauma; Pneumatosis Intestinalis; Ischemic Bowel; Raynaud Syndrome; Malignant Otitis Externa; Nonarteritic Anterior Ischemic Optic Neuropathy; Central Retinal Vein Occlusion; Femoral Head Necrosis; Invasive Fungal Infection; Chronic Anal Fissure; Vasculitic Ulcer; Graft-vs-Host Disease; Decubitus Ulcer; Greater Trochanteric Pain Syndrome; Rectovaginal Fistula; Pouchitis; Tinnitus; Clostridium Enterocolitis; Branch Retinal Artery Occlusion; Axonotmesis; Multiple Sclerosis; Inclusion Body Myositis; Epidermolysis Bullosa (EB); Osteonecrosis; Ulcer Ischemic; Avascular Necrosis of Bone; Prosthesis Related Infections; Facial Filler Injections; Cystitis Chronic; Ligament Injury; Anastomosis, Leaking; Cartilage Injury; Post-COVID-19 Condition; Ulcerative Colitis; Crohn Disease

Outcome Measures

Primary Outcomes (1)

• Quality of Life EuroQOL EQ-5D-5L Questionnaire

  Every individual has quality of life measured using the EuroQol EQ-5D-5L measure. The measure has 5 scales (Mobility, Self-Care, Usual Activities, Pain/Discomfort, and Anxiety/Depression), that each have 5 levels (none, slight, moderate, severe, unable). The scores are calculated using the procedures outlined in the EuroQOL handbook to create a final score on a 0-1 scale. There is also an overall visual analog scale that asks about perceived health on a 0-100 scale. Higher scores indicate better quality of life. Data are aggregated in the Multicenter Registry for Hyperbaric Oxygen Treatment.

  Within one week of starting HBO2 and within one week of ending HBO2 treatment

Secondary Outcomes (11)

• Urogenital Distress Inventory

  Within one week of starting HBO2 treatments and within one week completing HBO2 treatments

• Bowel symptoms questionnaire

  Within one week of starting HBO2 treatments and within one week completing HBO2 treatments

• Head and Neck Questionnaire

  Within one week of starting HBO2 treatments and within one week completing HBO2 treatments

• Perianal Crohn's Symptom Index Questionnaire

  Within one week of starting HBO2 treatments and within one week completing HBO2 treatments

• Hip dysfunction and Osteoarthritis Outcome Score (HOOS) Questionnaire

  Within one week of starting HBO2 treatments and within one week completing HBO2 treatments

Study Arms (1)

Hyperbaric oxygen treated group

EXPERIMENTAL

This individuals will be receiving hyperbaric oxygen treatment for the condition listed in the conditions section. Patients come daily for the treatment and receive hyperbaric oxygen at 2.0-2.4 atmospheres absolute for 90 minutes at the treatment pressure.

Device: Hyperbaric oxygen treatment (HBOT); Drug: 100% Oxygen

Interventions

Hyperbaric oxygen treatment (HBOT) DEVICE

Hyperbaric oxygen refers to oxygen given at pressures higher than atmospheric pressure (higher than 1.4 ATA) in pressurized chamber.

Also known as: HBO2

Hyperbaric oxygen treated group

100% Oxygen DRUG

Receiving 100% oxygen as part of HBOT

Also known as: O2

Hyperbaric oxygen treated group

Eligibility Criteria

• Sex: all
• Healthy Volunteers: No
• Age Groups: Child (0-17), Adult (18-64), Older Adult (65+)

You may qualify if:

• Patients referred for HBOT with an emerging indication

You may not qualify if:

• Contraindication to hyperbaric oxygen treatment (untreated seizures, pneumothorax, significant pulmonary airspace pathology that might lead to pulmonary barotrauma, unmanageable confinement anxiety, chronic obstructive pulmonary disease with CO2 retention)
• Pregnant persons

Sponsors & Collaborators

• Jay C. Buckey Jr.: lead
• Dartmouth College: collaborator

Related Publications (4)

• Tanaka HL, Rees JR, Zhang Z, Ptak JA, Hannigan PM, Silverman EM, Peacock JL, Buckey JC; Multicenter Registry for Hyperbaric Oxygen Treatment Consortium. Emerging Indications for Hyperbaric Oxygen Treatment: Registry Cohort Study. Interact J Med Res. 2024 Aug 20;13:e53821. doi: 10.2196/53821.

  PMID: 39078624 BACKGROUND

• Harlan NP, Ptak JA, Rees JR, Cowan DR, Fellows AM, Moses RA, Kertis JA, Hannigan PM, Juggan SA, Peacock J, Bennett M, Buckey JC. International Multicenter Registry for Hyperbaric Oxygen Therapy: Results through June 2021. Undersea Hyperb Med. 2022 Third Quarter;49(3):275-287.

  PMID: 36001560 BACKGROUND

• Harlan NP, Ptak JA, Rees JR, Cowan DR, Fellows AM, Kertis JA, Hannigan PM, Peacock JL, Buckey JC. Development of an International, Multicenter, Hyperbaric Oxygen Treatment Registry and Research Consortium: Protocol for Outcome Data Collection and Analysis. JMIR Res Protoc. 2020 Aug 17;9(8):e18857. doi: 10.2196/18857.

  PMID: 32579537 BACKGROUND

• 1. Huang ET. Hyperbaric Medicine Indications Manual. 15th ed. North Palm Beach, FL: Best Publishing Company; 2023 2023. 445 p.

  BACKGROUND

MeSH Terms

Conditions

Colitis, Ulcerative; Crohn Disease; Calciphylaxis; Frostbite; Pyoderma Gangrenosum; Pterygium; Hypospadias; Craniocerebral Trauma; Raynaud Disease; Optic Neuropathy, Ischemic; Retinal Vein Occlusion; Invasive Fungal Infections; Graft vs Host Disease; Pressure Ulcer; Rectovaginal Fistula; Pouchitis; Tinnitus; Enterocolitis, Pseudomembranous; Retinal Artery Occlusion; Trauma, Nervous System; Multiple Sclerosis; Myositis, Inclusion Body; Epidermolysis Bullosa; Osteonecrosis; Prosthesis-Related Infections

Interventions

Oxygen

Condition Hierarchy (Ancestors)

Colitis; Gastroenteritis; Gastrointestinal Diseases; Digestive System Diseases; Inflammatory Bowel Diseases; Colonic Diseases; Intestinal Diseases; Calcinosis; Calcium Metabolism Disorders; Metabolic Diseases; Nutritional and Metabolic Diseases; Cold Injury; Wounds and Injuries; Pyoderma; Skin Diseases; Skin and Connective Tissue Diseases; Skin Diseases, Vascular; Skin Ulcer; Conjunctival Diseases; Eye Diseases; Urogenital Abnormalities; Female Urogenital Diseases; Female Urogenital Diseases and Pregnancy Complications; Urogenital Diseases; Penile Diseases; Genital Diseases, Male; Genital Diseases; Male Urogenital Diseases; Congenital Abnormalities; Congenital, Hereditary, and Neonatal Diseases and Abnormalities; Nervous System Diseases; Livedoid Vasculopathy; Thrombosis; Embolism and Thrombosis; Vascular Diseases; Cardiovascular Diseases; Peripheral Vascular Diseases; Optic Nerve Diseases; Cranial Nerve Diseases; Retinal Diseases; Venous Thrombosis; Mycoses; Bacterial Infections and Mycoses; Infections; Immune System Diseases; Rectal Fistula; Intestinal Fistula; Digestive System Fistula; Rectal Diseases; Vaginal Fistula; Vaginal Diseases; Genital Diseases, Female; Fistula; Pathological Conditions, Anatomical; Pathological Conditions, Signs and Symptoms; Ileitis; Enteritis; Ileal Diseases; Hearing Disorders; Ear Diseases; Otorhinolaryngologic Diseases; Sensation Disorders; Neurologic Manifestations; Signs and Symptoms; Clostridium Infections; Gram-Positive Bacterial Infections; Bacterial Infections; Enterocolitis; Arterial Occlusive Diseases; Demyelinating Autoimmune Diseases, CNS; Autoimmune Diseases of the Nervous System; Demyelinating Diseases; Autoimmune Diseases; Myositis; Muscular Diseases; Musculoskeletal Diseases; Neuromuscular Diseases; Skin Abnormalities; Skin Diseases, Genetic; Genetic Diseases, Inborn; Skin Diseases, Vesiculobullous; Bone Diseases; Necrosis; Pathologic Processes; Postoperative Complications

Intervention Hierarchy (Ancestors)

Chalcogens; Elements; Inorganic Chemicals; Gases

Study Officials

• Jay Buckey

  Dartmouth-Hichcock Medical Center

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Samantha Leigh

CONTACT

540-819-5715; samantha.m.leigh@dartmouth.edu

Jay Buckey

CONTACT

Jay.C.Buckey.Jr@dartmouth.edu

Study Design

• Study Type: interventional
• Phase: phase 4
• Allocation: NA
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: SPONSOR INVESTIGATOR
• PI Title: Principal Investigator

Study Record Dates

• First Submitted: October 26, 2025
• First Posted: November 21, 2025
• Study Start (Estimated): August 1, 2026
• Primary Completion (Estimated): December 1, 2035
• Study Completion (Estimated): December 1, 2035
• Last Updated: May 5, 2026

Record last verified: 2026-05