Hypermobile Ehlers-Danlos Syndrome Clinical Trial
— ProprioRespiOfficial title:
Lung Volume Perception and Impact of a Cognitive Task on Ventilation in Healthy Subjects and Subjects With Hypermobile Ehlers-Danlos Syndrome.
NCT number | NCT05000151 |
Other study ID # | ProprioRespi |
Secondary ID | |
Status | Completed |
Phase | |
First received | |
Last updated | |
Start date | September 2, 2021 |
Est. completion date | May 19, 2022 |
Verified date | July 2022 |
Source | Clinique de la Mitterie |
Contact | n/a |
Is FDA regulated | No |
Health authority | |
Study type | Observational |
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.
Status | Completed |
Enrollment | 38 |
Est. completion date | May 19, 2022 |
Est. primary completion date | May 19, 2022 |
Accepts healthy volunteers | Accepts Healthy Volunteers |
Gender | All |
Age group | 18 Years and older |
Eligibility | Inclusion Criteria (common): - More than 18 years old - Understanding French Inclusion Criteria (hEDS Patients): - hEDS diagnosis Inclusion Criteria (healthy subjects): - Age (±5 years), Gender and BMI (±2.5kg/m²) matching Exclusion Criteria (common): - Pregnancy Exclusion Criteria (hEDS Patients): - Respiratory comorbidity independent of hEDS - Previous participation in a rehabilitation programme at the clinic Exclusion Criteria (healthy subjects): - Known respiratory or proprioceptive pathology - Hypermobility (evaluated with the Beighton score) |
Country | Name | City | State |
---|---|---|---|
France | Clinique de la Mitterie | Lomme |
Lead Sponsor | Collaborator |
---|---|
Hakimi Adrien |
France,
Type | Measure | Description | Time frame | Safety issue |
---|---|---|---|---|
Primary | 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. | Baseline | |
Secondary | 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). | Baseline | |
Secondary | 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. | Baseline |
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