Hypermobile Ehlers-Danlos SyndromeProprioRespiNCT05000151
Lung Volume Perception and Impact of a Cognitive Task on Ventilation in Hypermobile Ehlers-Danlos Syndrome.
An observational study of Hypermobile Ehlers-Danlos Syndrome, run by Hakimi Adrien at 1 site in France.
Trial summary
Patients with hypermobile Ehlers-Danlos syndrome have respiratory and proprioceptive disorders. The aim of this study is to explore whether there is an alteration in lung volume perception in patients with hEDS compared to healthy subjects, and whether a cognitive task can influence ventilation control differently in… Read more about this study
- Who is it for?
- Ages 18 years and olderHealthy volunteers can take part
- Conditions the study is for
- Hypermobile Ehlers-Danlos Syndrome
- How many people
- 38 participants
- Where
- 1 siteFrance
- Study dates
- 2 Sep 2021to 19 May 2022
- Phase
- Observational
- 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
- Healthy volunteers accepted
- Adult, Older adult
Study population: Patients will be recruited through practitioners working with the clinic, who will propose participation in the study during consultations with patients diagnosed with EDS. The recruitment of subjects for the control group will be carried out by internal communication within the Clinique de la Mitterie on a voluntary basis.
Who may be able to join
- More than 18 years old
- Understanding French
- hEDS diagnosis
- Age (±5 years), Gender and BMI (±2.5kg/m²) matching
Who cannot join
- Pregnancy
- Respiratory comorbidity independent of hEDS
- Previous participation in a rehabilitation programme at the clinic
- Known respiratory or proprioceptive pathology
- Hypermobility (evaluated with the Beighton score)
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Lung Volume Perception and Impact of a Cognitive Task on Ventilation in Healthy Subjects and Subjects With Hypermobile Ehlers-Danlos Syndrome.
Patients with hypermobile Ehlers-Danlos syndrome have respiratory and proprioceptive disorders. The aim of this study is to explore whether there is an alteration in lung volume perception in patients with hEDS compared to healthy subjects, and whether a cognitive task can influence ventilation control differently in subjects with hEDS than in healthy subjects.
- Conditions
- Hypermobile Ehlers-Danlos Syndrome
- Medical subject headings
- Ehlers-Danlos syndrome type 3
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
| Study group | Role | What they receive |
|---|---|---|
| Patients | Hypermobile Ehlers-Danlos patients (n=21) | |
| Healthy subjects | Healthy subjects recruited from the clinic's staff (n=21) Age, Gender and BMI matched with hEDS patients |
What is being measured
The primary outcome is the main question the study is designed to answer.
Accuracy of lung volume perception
The perception of lung volume is assessed using a device comprising a flow meter, an electronic acquisition card and an LCD screen. Subjects will be given 3 trials to train to perceive a target lung volume and then 3 trials without feedback to reproduce that target lung volume. The mean of the absolute deviations from the target volumes in percent is used as the primary outcome.
Measured: Baseline
Secondary outcomes (2)
Minute ventilation with or without cognitive task
The minute ventilation will be calculated over 1 minute without cognitive task and then over 1 minute with cognitive task (trail making test part B).
Measured: Baseline
Respiratory rate variability
The time interval between each inspiratory peak will be recorded and will allow the calculation of the standard deviation and the root mean square with and without the cognitive task.
Measured: Baseline
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted11 Aug 2021
- Study start2 Sep 2021
- Primary completion19 May 2022
- Study completion19 May 2022
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for Hypermobile 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
- Observational
- Observational model
- Case-control
- Time perspective
- Cross-sectional
- Enrolment
- 38 participants (actual)
Sponsor and investigators
- Lead sponsor
- Hakimi Adrien
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor-investigator, Hakimi Adrien, Clinique de la Mitterie
- Investigators
- Cyrille Bergoin, MD, Principal investigator, Clinique de la MitteriePatrick Mucci, Prof., Study director, UREPSSS
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05000151
- Sponsor's protocol ID
- ProprioRespi
- Acronym
- ProprioRespi
- Status last verified
- Jul 2022
- First submitted
- 30 Jul 2021
- Last updated
- 22 Jul 2022
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Publications
Hakimi A, Bergoin C, De Jesus A, Hermand E, Fabre C, Mucci P. Impairment of lung volume perception and breathing control in hypermobile Ehlers-Danlos syndrome. Sci Rep. 2024 Apr 6;14(1):8119. doi: 10.1038/s41598-024-58890-2.
PubMed 38582758
Study at a glance
From the registry record, last updated by the sponsor on 22 Jul 2022. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Lung Volume Perception and Impact of a Cognitive Task on Ventilation in Healthy Subjects and Subjects With Hypermobile Ehlers-Danlos Syndrome.
- ClinicalTrials.gov ID
- NCT05000151
- Acronym / sponsor ID
- ProprioRespi / ProprioRespi
- Conditions
- Hypermobile Ehlers-Danlos Syndrome
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 38 participants (actual)
- Lead sponsor
- Hakimi AdrienUniversity, hospital or other
- Study start
- 2 Sep 2021 (actual)
- Primary completion
- 19 May 2022 (actual)
- Study completion
- 19 May 2022 (actual)
- First posted
- 11 Aug 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.
Patients with hypermobile Ehlers-Danlos syndrome have respiratory and proprioceptive disorders. The aim of this study is to explore whether there is an alteration in lung volume perception in patients with hEDS compared to healthy subjects, and whether a cognitive task can influence ventilation control differently in subjects with hEDS than in healthy subjects.
Study design
- Observational model
- Case-control
- Time perspective
- Cross-sectional
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Patients | – | –Hypermobile Ehlers-Danlos patients (n=21) |
| Healthy subjects | – | –Healthy subjects recruited from the clinic's staff (n=21) Age, Gender and BMI matched with hEDS patients |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
- Study population
- Patients will be recruited through practitioners working with the clinic, who will propose participation in the study during consultations with patients diagnosed with EDS. The recruitment of subjects for the control group will be carried out by internal communication within the Clinique de la Mitterie on a voluntary basis.
Key inclusion criteria (4 listed)
- More than 18 years old
- Understanding French
- hEDS diagnosis
- Age (±5 years), Gender and BMI (±2.5kg/m²) matching
Key exclusion criteria (5 listed)
- Pregnancy
- Respiratory comorbidity independent of hEDS
- Previous participation in a rehabilitation programme at the clinic
- Known respiratory or proprioceptive pathology
- Hypermobility (evaluated with the Beighton score)
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Primary outcome
Accuracy of lung volume perception
Time frame: Baseline
The perception of lung volume is assessed using a device comprising a flow meter, an electronic acquisition card and an LCD screen. Subjects will be given 3 trials to train to perceive a target lung volume and then 3 trials without feedback to reproduce that target lung volume. The mean of the absolute deviations from the target volumes in percent is used as the primary outcome.
2 secondary outcomes
Minute ventilation with or without cognitive task
Time frame: Baseline
Respiratory rate variability
Time frame: Baseline
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 22 Jul 2022.
- Derived from this study: PubMed 38582758Hakimi A, Bergoin C, De Jesus A, Hermand E, Fabre C, Mucci P. Impairment of lung volume perception and breathing control in hypermobile Ehlers-Danlos syndrome. Sci Rep. 2024 Apr 6;14(1):8119. doi: 10.1038/s41598-024-58890-2.
- Individual participant dataSharing planned: No
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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.
Cyrille Bergoin, MD principal investigator
Clinique de la Mitterie
Patrick Mucci, Prof. study director
UREPSSS
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Hypermobile Ehlers-Danlos Syndrome, run by Hakimi Adrien at 1 site 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 4 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: finished, as of the sponsor's last update on 22 Jul 2022. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site 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. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Accuracy of lung volume perception (time frame: Baseline). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT05000151, which also lists 1 linked publication.
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 22 Jul 2022.