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Completed

NCT Number: NCT05000151

Lung Volume Perception and Impact of a Cognitive Task on Ventilation in 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.

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Key information

Conditions

Hypermobile Ehlers-Danlos Syndrome Ehlers-Danlos syndrome type 3

Age range

18 year and older

Sex eligibility

All sexes

Study type

Observational

Primary location

Clinique de la Mitterie

Lomme, 59160, France

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

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)

Treatment and study plan

Primary outcomes

  1. 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.

Secondary outcomes

  1. Minute ventilation with or without cognitive task

    Time frame: 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).

  2. Respiratory rate variability

    Time frame: 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.

Sponsors and collaborators

Lead sponsor

Hakimi Adrien

Other

Registry information

Official study title

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

Acronym: ProprioRespi

Important dates

Study start
2021
Primary completion
2022
Study completion
2022
First posted
Aug 11, 2021
Registry last updated
Jul 22, 2022

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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