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

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Know the risks and potential benefits of clinical studies and talk to your health care provider before participating. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT04890431
Recruitment Status : Recruiting
First Posted : May 18, 2021
Last Update Posted : March 31, 2022
Sponsor:
Information provided by (Responsible Party):
Hospital St. Joseph, Marseille, France

Study Description
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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).

Condition or disease Intervention/treatment Phase
Ehlers-Danlos Syndrome Drug: Oxygen Drug: Placebo Phase 4

Study Design
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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 82 participants
Allocation: Randomized
Intervention Model: Crossover Assignment
Masking: Triple (Participant, Investigator, Outcomes Assessor)
Primary Purpose: Supportive Care
Official Title: Impact of Oxygen Therapy on Fatigue in Patients With Hypermobile-type Ehlers-Danlos Syndrome: a Randomised Double-blind Placebo-controlled Study
Actual Study Start Date : March 10, 2022
Estimated Primary Completion Date : October 2023
Estimated Study Completion Date : January 2024

Resource links provided by the National Library of Medicine


Arms and Interventions
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Arm Intervention/treatment
Experimental: Oxygen Drug: Oxygen
oxygen treatment (5 L/minute for 30 minutes by nasal cannula, twice/day)
Placebo Comparator: Placebo Drug: Placebo
ambient air not enriched with oxygen (5 L/minute for 30 minutes by nasal cannula, twice/day)


Outcome Measures
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Primary Outcome Measures :
  1. FSS (Fatigue Severity Scale) score [ Time Frame: 7 months ]
  2. FSS (Fatigue Severity Scale) score [ Time Frame: 10 months ]

Secondary Outcome Measures :
  1. PRISM (Pictorial Representation of Illness and Self Measure) score [ Time Frame: 7 and 10 months ]
  2. SF-36 quality of life questionnaire (Short Form Heath Survey) score [ Time Frame: 7 and 10 months ]
  3. TSK (Tampa Scale Kinesiophobia) score [ Time Frame: 7 and 10 months ]
  4. walk test results [ Time Frame: 7 and 10 months ]
  5. HIT-6 (Headache Impact Test) score [ Time Frame: 7 and 10 months ]
  6. NQ (Nijmegen questionnaire ) score [ Time Frame: 7 and 10 months ]
  7. Epworth Sleepiness score [ Time Frame: 7 and 10 months ]
  8. PSQI (Pittsburgh sleep quality index) score [ Time Frame: 7 and 10 months ]
  9. HADS (Hospital Anxiety and Depression Scale) score [ Time Frame: 7 and 10 months ]
  10. NYHA (New Year Heart Association) score [ Time Frame: 7 and 10 months ]
  11. consumption of care [ Time Frame: 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.

  12. Number of oxygen therapy sessions followed by the patient [ Time Frame: 7 and 10 months ]

Eligibility Criteria
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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

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.
Contacts and Locations
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Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT04890431


Contacts
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Contact: Cécile Bielmann 04 88 73 10 70 ext 0033 cbielmann@hopital-saint-joseph.fr

Locations
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France
Hopital Raymond Poincaré Recruiting
Garches, France
Contact: Leonidas Degila         
Principal Investigator: Karelle Benistan, M.D         
Clinique de la Mitterie Recruiting
Lille, France
Contact: Nada El Fazazy         
Principal Investigator: Cyril Bergoin, M.D         
Hopital Saint Joseph Recruiting
Marseille, France
Contact: Cécile Bielmann         
Principal Investigator: Boris Bienvenu, M.D         
Sponsors and Collaborators
Hospital St. Joseph, Marseille, France
Investigators
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Principal Investigator: Boris Bienvenu Hopital Saint Joseph Marseille
More Information
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Responsible Party: Hospital St. Joseph, Marseille, France
ClinicalTrials.gov Identifier: NCT04890431    
Other Study ID Numbers: OXYSED
First Posted: May 18, 2021    Key Record Dates
Last Update Posted: March 31, 2022
Last Verified: March 2022

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
Additional relevant MeSH terms:
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Ehlers-Danlos Syndrome
Syndrome
Disease
Pathologic Processes
Hemostatic Disorders
Vascular Diseases
Cardiovascular Diseases
Hemorrhagic Disorders
 Hematologic Diseases
Skin Abnormalities
Congenital Abnormalities
Skin Diseases, Genetic
Genetic Diseases, Inborn
Collagen Diseases
Connective Tissue Diseases
Skin Diseases