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Impact of Oxygen Therapy on Fatigue in Patients With Hypermobile-type Ehlers-Danlos Syndrome

NCT04890431 · Status: UNKNOWN · Phase: PHASE4 · Type: INTERVENTIONAL · Enrollment: 82

Last updated 2022-03-31

No results posted yet for this study

Summary

The hypothesis of the OXYSED study is that the delivery of 3 months of oxygen therapy via an oxygen concentrator would reduce fatigue, pain, headaches, kinesiophobia, drug intake, dyspnea, and improve walking performance, quality of sleep and quality of life of patients with Ehlers Danlos syndrome hypermobility type (EDS / HT).

Conditions

  • Ehlers-Danlos Syndrome

Interventions

DRUG

Oxygen

oxygen treatment (5 L/minute for 30 minutes by nasal cannula, twice/day)

DRUG

Placebo

ambient air not enriched with oxygen (5 L/minute for 30 minutes by nasal cannula, twice/day)

Sponsors & Collaborators

  • Hospital St. Joseph, Marseille, France

    lead OTHER

Principal Investigators

  • Boris Bienvenu · Hopital Saint Joseph Marseille

Study Design

Allocation
RANDOMIZED
Purpose
SUPPORTIVE_CARE
Masking
TRIPLE
Model
CROSSOVER

Eligibility

Min Age
18 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2022-03-10
Primary Completion
2023-10-31
Completion
2024-01-31

Countries

  • France

Study Locations

More Related Trials

Entities

Drugs

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 NCT04890431 on ClinicalTrials.gov