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

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

Status

Completed

Phases

Unknown

Study type

Observational

Source

ClinicalTrials.gov

Registry ID

NCT05000151

Acronym

ProprioRespi

Enrollment

Registered

2021-08-11

Start date

2021-09-02

Completion date

2022-05-19

Last updated

2022-07-22

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Hypermobile Ehlers-Danlos Syndrome

Brief 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.

Interventions

None listed

Study design

Observational model

CASE_CONTROL

Time perspective

CROSS_SECTIONAL

Eligibility

Sex/Gender

ALL

Age

18 Years to No maximum

Healthy volunteers

Yes

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

Design outcomes

Primary

Measure	Time frame	Description
Accuracy of lung volume perception	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.

Secondary

Measure	Time frame	Description
Minute ventilation with or without cognitive task	Baseline	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).
Respiratory rate variability	Baseline	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.

Countries

France

Outcome results