Status:
UNKNOWN
Impact of Oxygen Therapy on Fatigue in Patients With Hypermobile-type Ehlers-Danlos Syndrome
Lead Sponsor:
Hospital St. Joseph, Marseille, France
Conditions:
Ehlers-Danlos Syndrome
Eligibility:
All Genders
18+ years
Phase:
PHASE4
Brief 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...
Eligibility Criteria
Inclusion
- 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
- 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.
Key Trial Info
Start Date :
March 10 2022
Trial Type :
INTERVENTIONAL
Allocation :
ESTIMATED
End Date :
January 1 2024
Estimated Enrollment :
82 Patients enrolled
Trial Details
Trial ID
NCT04890431
Start Date
March 10 2022
End Date
January 1 2024
Last Update
March 31 2022
Active Locations (3)
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1
Hopital Raymond Poincaré
Garches, France
2
Clinique de la Mitterie
Lille, France
3
Hopital Saint Joseph
Marseille, France