Clinical trial NCT04890431: Impact of Oxygen Therapy on Fatigue in Patients With Hypermobile-type Ehlers-Danlos Syndrome
Official title: Impact of Oxygen Therapy on Fatigue in Patients With Hypermobile-type Ehlers-Danlos Syndrome: a Randomised Double-blind Placebo-controlled Study
Study type: INTERVENTIONAL
Overall status: UNKNOWN
Phase: PHASE4
Conditions: Ehlers-Danlos Syndrome
Lead sponsor: Hospital St. Joseph, Marseille, France
Sponsor class: OTHER
First posted: 2021-05-18
Enrollment: 82
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: CROSSOVER
Primary purpose: SUPPORTIVE_CARE

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 walking performance, quality of sleep and quality of life of patients with Ehlers Danlos syndrome hypermobility type (EDS / HT).


Eligibility 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.

Primary outcomes:
measure: FSS (Fatigue Severity Scale) score
timeFrame: 7 months
measure: FSS (Fatigue Severity Scale) score
timeFrame: 10 months
Secondary outcomes:
measure: PRISM (Pictorial Representation of Illness and Self Measure) score
timeFrame: 7 and 10 months
measure: SF-36 quality of life questionnaire (Short Form Heath Survey) score
timeFrame: 7 and 10 months
measure: TSK (Tampa Scale Kinesiophobia) score
timeFrame: 7 and 10 months
measure: walk test results
timeFrame: 7 and 10 months
measure: HIT-6 (Headache Impact Test) score
timeFrame: 7 and 10 months
measure: NQ (Nijmegen questionnaire ) score
timeFrame: 7 and 10 months
measure: Epworth Sleepiness score
timeFrame: 7 and 10 months
measure: PSQI (Pittsburgh sleep quality index) score
timeFrame: 7 and 10 months
measure: HADS (Hospital Anxiety and Depression Scale) score
timeFrame: 7 and 10 months
measure: NYHA (New Year Heart Association) score
timeFrame: 7 and 10 months
measure: consumption of care
timeFrame: 7 and 10 months
measure: Number of oxygen therapy sessions followed by the patient
timeFrame: 7 and 10 months
Other outcomes:
Locations:
city: Garches
country: France
facility: Hopital Raymond Poincaré
city: Lille
country: France
facility: Clinique de la Mitterie
city: Marseille
country: France
facility: Hopital Saint Joseph
Study officials:
affiliation: Hopital Saint Joseph Marseille
name: Boris Bienvenu
role: PRINCIPAL_INVESTIGATOR
References: