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

Last updated: March 15, 2022
Sponsor: Hospital St. Joseph, Marseille, France
Overall Status: Active - Recruiting

Phase

4

Condition

Connective Tissue Diseases

Treatment

N/A

Clinical Study ID

NCT04890431
OXYSED
  • Ages > 18
  • All Genders

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).

Eligibility Criteria

Inclusion

Inclusion Criteria:

  • Aged ≥ 18 years;
  • Diagnosed with EDS/HT defined by the New York critieria;
  • With intense fatigue defined by an FSS ≥ 4;
  • Having given free and informed written consent;
  • Speaking french language;
  • Being affiliated with or benefiting from a social security scheme.

Exclusion

Exclusion Criteria:

  • with progressive parenchymal pulmonary pathology (pulmonary fibrosis, post-smokingemphysema);
  • having an ongoing pregnancy or breastfeeding;
  • who have already received oxygen therapy for the EDS / HT indication in the last 6months;
  • having a pathology that causes fatigue, which is not compensated or treated;non-exhaustive list anemia, sleep apnea syndrome, psychiatric pathologies includingsevere depression, organ failure (cardiac, renal, respiratory, hepatic),endocrinopathies (hypo or hyperthyroidism, diabetes), nutritional deficiencies;
  • Subject to a measure for the protection of justice.

Study Design

Total Participants: 82
Study Start date:
March 10, 2022
Estimated Completion Date:
January 31, 2024

Connect with a study center

  • Hopital Raymond Poincaré

    Garches,
    France

    Active - Recruiting

  • Clinique de la Mitterie

    Lille,
    France

    Active - Recruiting

  • Hopital Saint Joseph

    Marseille,
    France

    Active - Recruiting

Not the study for you?

Let us help you find the best match. Sign up as a volunteer and receive email notifications when clinical trials are posted in the medical category of interest to you.