Lung Volume Perception and Impact of a Cognitive Task on Ventilation in Hypermobile Ehlers-Danlos Syndrome.

Hypermobile Ehlers-Danlos Syndrome Clinical Trial

— ProprioRespi  

Official title:

Lung Volume Perception and Impact of a Cognitive Task on Ventilation in Healthy Subjects and Subjects With Hypermobile Ehlers-Danlos Syndrome.

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT05000151
• Other study ID #: ProprioRespi
• Status: Completed
• Start date: September 2, 2021
• Est. completion date: May 19, 2022

Study information

• Verified date: July 2022
• Source: Clinique de la Mitterie
• Contact: n/a
• Is FDA regulated: No
• Study type: Observational

Clinical 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 subjects with hEDS than in healthy subjects.

Recruitment information / eligibility

• 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)

Related Conditions & MeSH terms

• Ehlers-Danlos Syndrome
• Hypermobile Ehlers-Danlos Syndrome
• Syndrome

Locations

Country	Name	City	State
France	Clinique de la Mitterie	Lomme

Sponsors (1)

Lead Sponsor	Collaborator
Hakimi Adrien

Country where clinical trial is conducted

France, 

Outcome

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