Ehlers-Danlos Syndrome
Conditions
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).
Interventions
DRUGOxygen
oxygen treatment (5 L/minute for 30 minutes by nasal cannula, twice/day)
DRUGPlacebo
ambient air not enriched with oxygen (5 L/minute for 30 minutes by nasal cannula, twice/day)
Sponsors
Hospital St. Joseph, Marseille, France
Study design
Allocation
RANDOMIZED
Intervention model
CROSSOVER
Primary purpose
SUPPORTIVE_CARE
Masking
TRIPLE (Subject, Investigator, Outcomes Assessor)
Eligibility
Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
No
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.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| FSS (Fatigue Severity Scale) score | 7 months |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| 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 | — |
| 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 | — |
| Epworth Sleepiness 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 | — |
| consumption of care | 7 and 10 months | 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. |
| Number of oxygen therapy sessions followed by the patient | 7 and 10 months | — |
| TSK (Tampa Scale Kinesiophobia) score | 7 and 10 months | — |
Countries
France
Contacts
Primary ContactCécile Bielmann
Outcome results
None listed