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

NCT04890431 | Unknown Phase 4

• 1 other identifier: OXYSED
• Study Type: interventional
• Target: 82
• Locations: 1 country
• Sites: 3

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).

Conditions

Ehlers-Danlos Syndrome

Outcome Measures

Primary Outcomes (2)

• FSS (Fatigue Severity Scale) score

  7 months

• FSS (Fatigue Severity Scale) score

  10 months

Secondary Outcomes (12)

• 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

Study Arms (2)

Oxygen

EXPERIMENTAL

Drug: Oxygen

Placebo

PLACEBO COMPARATOR

Drug: Placebo

Interventions

Oxygen DRUG

oxygen treatment (5 L/minute for 30 minutes by nasal cannula, twice/day)

Oxygen

Placebo DRUG

ambient air not enriched with oxygen (5 L/minute for 30 minutes by nasal cannula, twice/day)

Placebo

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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.

You may not qualify if:

• 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.

Sponsors & Collaborators

• Hospital St. Joseph, Marseille, France: lead

Study Sites (3)

Hopital Raymond Poincaré

Garches, France

RECRUITING

Clinique de la Mitterie

Lille, France

RECRUITING

Hopital Saint Joseph

Marseille, France

RECRUITING

MeSH Terms

Conditions

Ehlers-Danlos Syndrome

Interventions

Oxygen

Condition Hierarchy (Ancestors)

Hemostatic Disorders; Vascular Diseases; Cardiovascular Diseases; Hemorrhagic Disorders; Hematologic Diseases; Hemic and Lymphatic Diseases; Skin Abnormalities; Congenital Abnormalities; Congenital, Hereditary, and Neonatal Diseases and Abnormalities; Skin Diseases, Genetic; Genetic Diseases, Inborn; Collagen Diseases; Connective Tissue Diseases; Skin and Connective Tissue Diseases; Skin Diseases

Intervention Hierarchy (Ancestors)

Chalcogens; Elements; Inorganic Chemicals; Gases

Study Officials

• Boris Bienvenu

  Hopital Saint Joseph Marseille

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Cécile Bielmann

CONTACT

04 88 73 10 70; cbielmann@hopital-saint-joseph.fr

Study Design

• Study Type: interventional
• Phase: phase 4
• Allocation: RANDOMIZED
• Masking: TRIPLE
• Who Masked: PARTICIPANT, INVESTIGATOR, OUTCOMES ASSESSOR
• Purpose: SUPPORTIVE CARE
• Intervention Model: CROSSOVER
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: May 6, 2021
• First Posted: May 18, 2021
• Study Start: March 10, 2022
• Primary Completion: October 1, 2023
• Study Completion: January 1, 2024
• Last Updated: March 31, 2022

Record last verified: 2022-03

Locations

FR (3)