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).
Study Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
SUPPORTIVE_CARE
Masking
TRIPLE
Enrollment
82
Hopital Raymond Poincaré
Garches, France
RECRUITINGClinique de la Mitterie
Lille, France
RECRUITINGHopital Saint Joseph
Marseille, France
RECRUITINGFSS (Fatigue Severity Scale) score
Time frame: 7 months
FSS (Fatigue Severity Scale) score
Time frame: 10 months
PRISM (Pictorial Representation of Illness and Self Measure) score
Time frame: 7 and 10 months
SF-36 quality of life questionnaire (Short Form Heath Survey) score
Time frame: 7 and 10 months
TSK (Tampa Scale Kinesiophobia) score
Time frame: 7 and 10 months
walk test results
Time frame: 7 and 10 months
HIT-6 (Headache Impact Test) score
Time frame: 7 and 10 months
NQ (Nijmegen questionnaire ) score
Time frame: 7 and 10 months
Epworth Sleepiness score
Time frame: 7 and 10 months
PSQI (Pittsburgh sleep quality index) score
Time frame: 7 and 10 months
HADS (Hospital Anxiety and Depression Scale) score
Time frame: 7 and 10 months
NYHA (New Year Heart Association) score
Time frame: 7 and 10 months
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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.
Time frame: 7 and 10 months
Number of oxygen therapy sessions followed by the patient
Time frame: 7 and 10 months