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

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

UNKNOWN

Clinical Phase

PHASE4

Total Enrollment

82 participants

Study Classification

INTERVENTIONAL

Study Start Date

2022-03-10

Study Completion Date

2024-01-31

Brief Summary

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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).

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Detailed Description

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Conditions

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Ehlers-Danlos Syndrome

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

CROSSOVER

Primary Study Purpose

SUPPORTIVE_CARE

Blinding Strategy

TRIPLE

Participants Investigators Outcome Assessors

Study Groups

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Oxygen

Group Type EXPERIMENTAL

Oxygen

Intervention Type DRUG

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

Placebo

Group Type PLACEBO_COMPARATOR

Placebo

Intervention Type DRUG

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

Interventions

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Oxygen

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

Intervention Type DRUG

Placebo

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

Intervention Type DRUG

Eligibility Criteria

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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.

Minimum Eligible Age

18 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No