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

Ehlers-Danlos Syndrome Clinical Trial

Official title:

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

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT04890431
• Other study ID #: OXYSED
• Status: Recruiting
• Phase: Phase 4
• Start date: March 10, 2022
• Est. completion date: January 2024

Study information

• Verified date: March 2022
• Source: Hospital St. Joseph, Marseille, France
• Contact: Cécile Bielmann
• Phone: 04 88 73 10 70
• Email: cbielmann[@]hopital-saint-joseph.fr
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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).

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 82
• Est. completion date: January 2024
• Est. primary completion date: October 2023
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

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.

Related Conditions & MeSH terms

• Ehlers-Danlos Syndrome
• Syndrome

Intervention

Drug:
• Oxygen
oxygen treatment (5 L/minute for 30 minutes by nasal cannula, twice/day)
• Placebo
ambient air not enriched with oxygen (5 L/minute for 30 minutes by nasal cannula, twice/day)

Locations

Country	Name	City	State
France	Hopital Raymond Poincaré	Garches
France	Clinique de la Mitterie	Lille
France	Hopital Saint Joseph	Marseille

Sponsors (1)

Lead Sponsor	Collaborator
Hospital St. Joseph, Marseille, France

Country where clinical trial is conducted

France, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	FSS (Fatigue Severity Scale) score		7 months
Primary	FSS (Fatigue Severity Scale) score		10 months
Secondary	PRISM (Pictorial Representation of Illness and Self Measure) score		7 and 10 months
Secondary	SF-36 quality of life questionnaire (Short Form Heath Survey) score		7 and 10 months
Secondary	TSK (Tampa Scale Kinesiophobia) score		7 and 10 months
Secondary	walk test results		7 and 10 months
Secondary	HIT-6 (Headache Impact Test) score		7 and 10 months
Secondary	NQ (Nijmegen questionnaire ) score		7 and 10 months
Secondary	Epworth Sleepiness score		7 and 10 months
Secondary	PSQI (Pittsburgh sleep quality index) score		7 and 10 months
Secondary	HADS (Hospital Anxiety and Depression Scale) score		7 and 10 months
Secondary	NYHA (New Year Heart Association) score		7 and 10 months
Secondary	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
Secondary	Number of oxygen therapy sessions followed by the patient		7 and 10 months