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

Phase 4

• Conditions: Ehlers-Danlos Syndrome
• Interventions: Drug: Placebo; Drug: Oxygen

• Registration Number: NCT04890431
• Lead Sponsor: Hospital St. Joseph, Marseille, France

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).

Detailed Description

Not available

Study Timeline

• Study First Submitted: 2021-05-06
• Study First Submitted QC: 2021-05-17
• Study First Posted: 2021-05-18
• Status Verified: 2022-03
• Study Start: 2022-03-10
• Last Update Submitted: 2022-03-15
• Last Update Posted: 2022-03-31
• Primary Completion: 2023-10
• Study Completion: 2024-01

Recruitment & Eligibility

• Status: UNKNOWN
• Sex: All
• Target Recruitment: 82

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.

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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.

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Study & Design

• Study Type: INTERVENTIONAL
• Study Design: CROSSOVER

Arm && Interventions

Group	Intervention	Description
Placebo	Placebo	-
Oxygen	Oxygen	-

Primary Outcome Measures

Name	Time	Method
FSS (Fatigue Severity Scale) score	10 months

Secondary Outcome Measures

Name	Time	Method
NYHA (New Year Heart Association) 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
HIT-6 (Headache Impact Test) 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
TSK (Tampa Scale Kinesiophobia) score	7 and 10 months
walk test results	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

Trial Locations

Locations (3)

Hopital Raymond Poincaré; 🇫🇷 Garches, France

Hopital Saint Joseph; 🇫🇷 Marseille, France

Clinique de la Mitterie; 🇫🇷 Lille, France