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

Overview

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).

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

Study Type

  • Study Type: Interventional
  • Study Design
    • Allocation: Randomized
    • Intervention Model: Crossover Assignment
    • Primary Purpose: Supportive Care
    • Masking: Triple (Participant, Investigator, Outcomes Assessor)
  • Study Primary Completion Date: October 2023

Interventions

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

Arms, Groups and Cohorts

  • Experimental: Oxygen
  • Placebo Comparator: Placebo

Clinical Trial Outcome Measures

Primary Measures

  • FSS (Fatigue Severity Scale) score
    • Time Frame: 7 months
  • FSS (Fatigue Severity Scale) score
    • Time Frame: 10 months

Secondary Measures

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

Participating in This Clinical Trial

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.

Gender Eligibility: All

Minimum Age: 18 Years

Maximum Age: N/A

Are Healthy Volunteers Accepted: No

Investigator Details

  • Lead Sponsor
    • Hospital St. Joseph, Marseille, France
  • Provider of Information About this Clinical Study
    • Sponsor
  • Overall Official(s)
    • Boris Bienvenu, Principal Investigator, Hopital Saint Joseph Marseille
  • Overall Contact(s)
    • Cécile Bielmann, 04 88 73 10 70, cbielmann@hopital-saint-joseph.fr

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