Overview

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

Status:
Not yet recruiting
Trial end date:
2022-04-01
Target enrollment:
0
Participant gender:
All
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).
Phase:
Phase 4
Accepts Healthy Volunteers?
No
Details
Lead Sponsor:
Hospital St. Joseph, Marseille, France
Criteria
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 Criteria:

- with progressive parenchymal pulmonary pathology (pulmonary fibrosis, post-smoking
emphysema);

- having an ongoing pregnancy or breastfeeding;

- who have already received oxygen therapy for the EDS / HT indication in the last 6
months;

- having a pathology that causes fatigue, which is not compensated or treated;
non-exhaustive list anemia, sleep apnea syndrome, psychiatric pathologies including
severe depression, organ failure (cardiac, renal, respiratory, hepatic),
endocrinopathies (hypo or hyperthyroidism, diabetes), nutritional deficiencies;

- Subject to a measure for the protection of justice.