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Clinical Trial Details — Status: Recruiting

Administrative data

NCT number NCT04890431
Other study ID # OXYSED
Secondary ID
Status Recruiting
Phase Phase 4
First received
Last updated
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
Health authority
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.

Study Design


Related Conditions & MeSH terms


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
See also
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