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Hyperbaric-oxygen Therapy (HBOT) Versus Placebo for Treating Vaso-Occlusive Crisis (VOC) in Sickle Cell Disease (SCD)

NCT05289700 · Status: UNKNOWN · Phase: PHASE3 · Type: INTERVENTIONAL · Enrollment: 100

Last updated 2022-11-02

No results posted yet for this study

Summary

This is a randomised, controlled, double-blind, placebo trial of HBOT (intervention) superiority in the treatment of VOC in SCD, to demonstrate the effectiveness of HBOT for the decrease in pain level in the treatment of SCD-VOC.

Conditions

Interventions

DEVICE

HBOT in Hyperbaric chamber

HBOT is the administration of oxygen (FIO2 = 100%) at a pressure higher than atmospheric pressure (2 ATA). The pressure increase is achieved by introducing compressed air into the hyperbaric chamber. This study will use a hyperbaric chamber that is already marketed, licensed and used in other diseases.

DEVICE

Hyperbaric chamber for placebo

Hyperbaric chamber is the same chamber used for HBOT, but here with a limited hyperpressure (1.3 ATA) and using ambient air (FIO2=0.21), with illusion of treatment in healthy volunteers. All other aspects of the procedure are identical to those of the intervention. As in the intervention arm, there will be a compression period (although shorter), of 5 min, followed by 85 min at 1.3 ATA, then a decompression period of 5 min (total duration of 95 min).

Sponsors & Collaborators

  • University Hospital, Toulouse

    collaborator OTHER

  • Hospices Civils de Lyon

    collaborator OTHER

  • University Hospital, Geneva

    lead OTHER

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
TRIPLE
Model
PARALLEL

Eligibility

Min Age
8 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2022-09-15
Primary Completion
2024-09-15
Completion
2025-03-31

Countries

  • France
  • Switzerland

Study Locations

More Related Trials

Entities

Diseases

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT05289700 on ClinicalTrials.gov