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

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

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).

Study Overview

• Status: Recruiting
• Conditions: Ehlers-Danlos Syndrome
• Intervention / Treatment: Drug: Oxygen; Drug: Placebo

• Study Type: Interventional
• Enrollment (Anticipated): 82
• Phase: Phase 4

Contacts and Locations

• Study Contact: Name: Cécile Bielmann; Phone Number: 0033 04 88 73 10 70; Email: cbielmann@hopital-saint-joseph.fr

Study Locations

• France
  • Garches, France
    • Recruiting
    • Hôpital Raymond Poincaré
    • Contact: Leonidas Degila
    • Principal Investigator: Karelle Benistan, M.D
  • Lille, France
    • Recruiting
    • Clinique de la Mitterie
    • Contact: Nada El Fazazy
    • Principal Investigator: Cyril Bergoin, M.D
  • Marseille, France
    • Recruiting
    • Hôpital Saint Joseph
    • Principal Investigator: Boris Bienvenu, M.D

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years and older (Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

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 Plan

How is the study designed?

Design Details

• Primary Purpose: Supportive Care
• Allocation: Randomized
• Interventional Model: Crossover Assignment
• Masking: Triple

Number of Arms

2

Arms and Interventions

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

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Time Frame
FSS (Fatigue Severity Scale) score	7 months
FSS (Fatigue Severity Scale) score	10 months

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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
HIT-6 (Headache Impact Test) 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
NYHA (New Year Heart Association) score		7 and 10 months
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
Number of oxygen therapy sessions followed by the patient		7 and 10 months

Collaborators and Investigators

• Sponsor: Hospital St. Joseph, Marseille, France
• Investigators: Principal Investigator: Boris Bienvenu, Hôpital Saint Joseph Marseille

Study record dates

Study Major Dates

• Study Start (Actual): March 10, 2022
• Primary Completion (Anticipated): October 1, 2023
• Study Completion (Anticipated): January 1, 2024

Study Registration Dates

• First Submitted: May 6, 2021
• First Submitted That Met QC Criteria: May 17, 2021
• First Posted (Actual): May 18, 2021

Study Record Updates

• Last Update Posted (Actual): March 31, 2022
• Last Update Submitted That Met QC Criteria: March 15, 2022
• Last Verified: March 1, 2022

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Pathologic Processes; Cardiovascular Diseases; Vascular Diseases; Skin Diseases; Disease; Congenital Abnormalities; Hematologic Diseases; Hemorrhagic Disorders; Genetic Diseases, Inborn; Connective Tissue Diseases; Hemostatic Disorders; Skin Diseases, Genetic; Skin Abnormalities; Collagen Diseases; Syndrome; Ehlers-Danlos Syndrome
• Other Study ID Numbers: OXYSED

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No