Ehlers-Danlos SyndromePhase 4NCT04890431
Impact of Oxygen Therapy on Fatigue in Patients With Hypermobile-type Ehlers-Danlos Syndrome
A Phase 4 study testing Oxygen in people with Ehlers-Danlos Syndrome, run by Hospital St. Joseph, Marseille, France at 3 sites in France.
Trial 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… Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Ehlers-Danlos Syndrome
- What is being tested?
- Oxygen
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 82 participants
- Where
- 3 sitesFrance
- Study dates
- 10 Mar 2022to Jan 2024
- Phase
- Phase 4
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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.
Who cannot join
- 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.
Trial locations and contacts
3 sites in 1 country.
France3 sites, 3 recruiting
- Recruiting
Hopital Raymond Poincaré
Garches
Leonidas Degila
Karelle Benistan, M.D
- Recruiting
Clinique de la Mitterie
Lille
Nada El Fazazy
Cyril Bergoin, M.D
- Recruiting
Hopital Saint Joseph
Marseille
Cécile Bielmann
Boris Bienvenu, M.D
About this study
Official title: 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).
- Conditions
- Ehlers-Danlos Syndrome
- Being tested
- Oxygen, Placebo
- Medical subject headings
- Ehlers-Danlos Syndrome
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
OxygenDrug
oxygen treatment (5 L/minute for 30 minutes by nasal cannula, twice/day)
PlaceboDrug
ambient air not enriched with oxygen (5 L/minute for 30 minutes by nasal cannula, twice/day)
| Study group | Role | What they receive |
|---|---|---|
| Oxygen | Experimental | Not described Receives: Drug: Oxygen |
| Placebo | Placebo comparator | Not described Receives: Drug: Placebo |
What is being measured
The primary outcome is the main question the study is designed to answer.
FSS (Fatigue Severity Scale) score
Measured: 7 months
FSS (Fatigue Severity Scale) score
Measured: 10 months
Secondary outcomes (12)
PRISM (Pictorial Representation of Illness and Self Measure) score
Measured: 7 and 10 months
SF-36 quality of life questionnaire (Short Form Heath Survey) score
Measured: 7 and 10 months
TSK (Tampa Scale Kinesiophobia) score
Measured: 7 and 10 months
walk test results
Measured: 7 and 10 months
HIT-6 (Headache Impact Test) score
Measured: 7 and 10 months
NQ (Nijmegen questionnaire ) score
Measured: 7 and 10 months
Epworth Sleepiness score
Measured: 7 and 10 months
PSQI (Pittsburgh sleep quality index) score
Measured: 7 and 10 months
HADS (Hospital Anxiety and Depression Scale) score
Measured: 7 and 10 months
NYHA (New Year Heart Association) score
Measured: 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.
Measured: 7 and 10 months
Number of oxygen therapy sessions followed by the patient
Measured: 7 and 10 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted18 May 2021
- Study start10 Mar 2022
- Primary completionOct 2023 (estimated)
- Study completionJan 2024 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Ehlers-Danlos SyndromeStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 4
- Primary purpose
- Supportive care
- Allocation
- Randomised
- Intervention model
- Crossover
- Masking
- Triple blind
- Who is masked
- Participant, Investigator, Outcomes assessor
- Enrolment
- 82 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Hospital St. Joseph, Marseille, France
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Boris Bienvenu, Principal investigator, Hopital Saint Joseph Marseille
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04890431
- Sponsor's protocol ID
- OXYSED
- Status last verified
- Mar 2022
- First submitted
- 6 May 2021
- Last updated
- 31 Mar 2022
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 31 Mar 2022. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Impact of Oxygen Therapy on Fatigue in Patients With Hypermobile-type Ehlers-Danlos Syndrome: a Randomised Double-blind Placebo-controlled Study
- ClinicalTrials.gov ID
- NCT04890431
- Acronym / sponsor ID
- OXYSED
- Conditions
- Ehlers-Danlos Syndrome
- Phase
- Phase 4
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 82 participants (estimated)
- Lead sponsor
- Hospital St. Joseph, Marseille, FranceUniversity, hospital or other
- Study start
- 10 Mar 2022 (actual)
- Primary completion
- Oct 2023 (estimated)
- Study completion
- Jan 2024 (estimated)
- First posted
- 18 May 2021 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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 design
- Primary purpose
- Supportive care
- Allocation
- Randomised
- Intervention model
- Crossover
- Masking
- Triple blind (participant, investigator, outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Oxygen | Experimental | Drug: Oxygen |
| Placebo | Placebo comparator | Drug: Placebo |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (6 listed)
- 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;
Key exclusion criteria (5 listed)
- 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.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Oxygenoxygen treatment (5 L/minute for 30 minutes by nasal cannula, twice/day) | Drug | Oxygen |
| Placeboambient air not enriched with oxygen (5 L/minute for 30 minutes by nasal cannula, twice/day) | Drug | Placebo |
Primary outcome
FSS (Fatigue Severity Scale) score
Time frame: 7 months
FSS (Fatigue Severity Scale) score
Time frame: 10 months
12 secondary outcomes
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
Number of oxygen therapy sessions followed by the patient
Time frame: 7 and 10 months
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 31 Mar 2022.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Boris Bienvenu principal investigator
Hopital Saint Joseph Marseille
3 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 4 study testing Oxygen in people with Ehlers-Danlos Syndrome, run by Hospital St. Joseph, Marseille, France at 3 sites in France.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 6 inclusion and 5 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: status not confirmed, as of the sponsor's last update on 31 Mar 2022. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 3 sites in France. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. Some participants in this study may receive a placebo. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Phase 4 studies take place after a treatment is approved, to learn more about its long-term benefits and risks in everyday use.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact Cécile Bielmann (04 88 73 10 70 ext. 0033, cbielmann@hopital-saint-joseph.fr), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
FSS (Fatigue Severity Scale) score (time frame: 7 months). The study lists 2 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 31 Mar 2022.