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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).
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Oxygen | Experimental |
| |
| Placebo | Placebo Comparator |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Oxygen | Drug | oxygen treatment (5 L/minute for 30 minutes by nasal cannula, twice/day) |
| |
| Measure | Description | Time Frame |
|---|---|---|
| FSS (Fatigue Severity Scale) score | 7 months | |
| FSS (Fatigue Severity Scale) score | 10 months |
| 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 | |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Role | Phone | Extension | |
|---|---|---|---|---|
| Cécile Bielmann | Contact | 04 88 73 10 70 | 0033 | cbielmann@hopital-saint-joseph.fr |
| Name | Affiliation | Role |
|---|---|---|
| Boris Bienvenu | Hopital Saint Joseph Marseille | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Hopital Raymond Poincaré | Recruiting | Garches | France |
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| ID | Term |
|---|---|
| D004535 | Ehlers-Danlos Syndrome |
| ID | Term |
|---|---|
| D020141 | Hemostatic Disorders |
| D014652 | Vascular Diseases |
| D002318 | Cardiovascular Diseases |
| D006474 | Hemorrhagic Disorders |
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| ID | Term |
|---|---|
| D010100 | Oxygen |
| ID | Term |
|---|---|
| D018011 | Chalcogens |
| D004602 | Elements |
| D007287 | Inorganic Chemicals |
| D005740 | Gases |
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| Placebo |
| Drug |
ambient air not enriched with oxygen (5 L/minute for 30 minutes by nasal cannula, twice/day) |
|
| 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:
| 7 and 10 months |
| Number of oxygen therapy sessions followed by the patient | 7 and 10 months |
| Clinique de la Mitterie | Recruiting | Lille | France |
|
| Hopital Saint Joseph | Recruiting | Marseille | France |
|
| D006402 |
| Hematologic Diseases |
| D006425 | Hemic and Lymphatic Diseases |
| D012868 | Skin Abnormalities |
| D000013 | Congenital Abnormalities |
| D009358 | Congenital, Hereditary, and Neonatal Diseases and Abnormalities |
| D012873 | Skin Diseases, Genetic |
| D030342 | Genetic Diseases, Inborn |
| D003095 | Collagen Diseases |
| D003240 | Connective Tissue Diseases |
| D017437 | Skin and Connective Tissue Diseases |
| D012871 | Skin Diseases |