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

Study Overview
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Brief Summary
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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).

Official Title
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Impact of Oxygen Therapy on Fatigue in Patients With Hypermobile-type Ehlers-Danlos Syndrome: a Randomised Double-blind Placebo-controlled Study

Conditions
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Ehlers-Danlos Syndrome

Intervention / Treatment
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* Drug: Oxygen
* Drug: Placebo


Participation Criteria
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Eligibility Criteria
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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.

Ages Eligible for Study
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Minimum Age: 18 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Supportive Care
Allocation: Randomized
Intervention Model: Crossover Assignment
Masking: Triple


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Oxygen<br> | Drug: Oxygen<br>* oxygen treatment (5 L/minute for 30 minutes by nasal cannula, twice/day)<br>|
| Placebo Comparator: Placebo<br> | Drug: Placebo<br>* ambient air not enriched with oxygen (5 L/minute for 30 minutes by nasal cannula, twice/day)<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| FSS (Fatigue Severity Scale) score |  | 7 months | 
| FSS (Fatigue Severity Scale) score |  | 10 months | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| PRISM (Pictorial Representation of Illness and Self Measure) score |  | 7 and 10 months | 
| SF-36 quality of life questionnaire (Short Form Heath Survey) score |  | 7 and 10 months | 
| TSK (Tampa Scale Kinesiophobia) score |  | 7 and 10 months | 
| walk test results |  | 7 and 10 months | 
| HIT-6 (Headache Impact Test) score |  | 7 and 10 months | 
| NQ (Nijmegen questionnaire ) score |  | 7 and 10 months | 
| Epworth Sleepiness score |  | 7 and 10 months | 
| PSQI (Pittsburgh sleep quality index) score |  | 7 and 10 months | 
| HADS (Hospital Anxiety and Depression Scale) score |  | 7 and 10 months | 
| NYHA (New Year Heart Association) score |  | 7 and 10 months | 
| consumption of care | The consumption of care is defined by the presence of at least one major criterion associated or not with the minor criterion: Major criteria: Variation of at least one level in the frequency of use and / or in the duration of use compared to the baseline assessment concerning the use of flexible and / or rigid orthoses, Variation of at least one level of the analgesic levels used compared to the baseline assessment for pain relievers. Variation of at least one level in frequency compared to the baseline assessment for physiotherapy sessions. Minor criterion: Variation of the total daily dose compared to the baseline assessment for painkillers. | 7 and 10 months | 
| Number of oxygen therapy sessions followed by the patient |  | 7 and 10 months |