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

Hospital Saint Joseph

Status and phase

Unknown

Phase 4

Conditions

Ehlers-Danlos Syndrome

Treatments

Drug: Placebo

Drug: Oxygen

Study type

Interventional

Funder types

Other

Identifiers

NCT04890431

OXYSED

Details and patient eligibility

About

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).

Enrollment

82 estimated patients

Sex

All

Ages

18+ years old

Volunteers

No Healthy Volunteers

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.