Prevalence of Rest Dyspnea and Impact of Non Invasive Ventilation on Breathing Sensations in CCHS Patients

Dyspnea Clinical Trial

— DyspnOndine  

Official title:

Prevalence of Rest Dyspnea and Impact of Non Invasive Ventilation on Breathing Sensations in Patients With Congenital Central Hypoventilation Syndrome

Clinical Trial Details — Status: Not yet recruiting

Administrative data

• NCT number: NCT04447196
• Other study ID #: 2020-A00215-34
• Status: Not yet recruiting
• Start date: December 15, 2021
• Est. completion date: October 1, 2022

Study information

• Verified date: July 2021
• Source: Association pour le Développement et l'Organisation de la Recherche en Pneumologie et sur le Sommeil
• Contact: MARLENE BRET
• Phone: 0698674449
• Email: marlene.bret[@]aphp.fr
• Is FDA regulated: No
• Study type: Observational

Clinical Trial Summary

Congenital central hypoventilation syndrome (CCHS) is a neuro-respiratory disease characterized by lifethreatening sleep-related hypoventilation involving an alteration of CO2/H+ chemosensitivity. This suggests cortical activity during awakening to maintain breathing. Cortical activity to keep breathing is usually associated with breathing discomfort ; this is the case in healthy subjects under non invasive ventilation (NIV) or with expiratory charge as well as in patients with amyotrophic lateral sclerosis. This can suggest that CCHS may be breathless at rest and this discomfort could be reduced by NIV.

The objective is to evaluate dyspnea with a multi dimensional score, MDP, in CCHS patient at rest in every day life and during 1H session of NIV.

The investigators will perform a prospective, including 20 CCHS patients. MDP scores will be measure before and after 1H-non invasive ventilation as well as a visual scale of 100mm in order to evaluate variation of breathing discomfort before/after NIV.

The investigators expect that CCHS patients don't have rest dyspnea but NIV would improve breathing discomfort that would mean they have latent rest dyspnea.

Recruitment information / eligibility

• Status: Not yet recruiting
• Enrollment: 20
• Est. completion date: October 1, 2022
• Est. primary completion date: October 1, 2022
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

Inclusion Criteria:

• patients with CCHS confirmed by genetic test

• patients with long term non invasive ventilation

• no recent condition that could impact breathing sensations such as infection, pulmonary embolism, heart failure

Exclusion Criteria:

• pregnancy

• phrenic nerve stimulation

Related Conditions & MeSH terms

• CCHS
• Congenital Central Hypoventilation Syndrome
• Dyspnea
• Hypoventilation
• Sleep Apnea, Central
• Syndrome

Intervention

Other:
• MDP
Multi dimensional dyspnea profile scores at rest and during non invasive ventilation

Locations

Country	Name	City	State
France	INSERM-UPC UMR_S 1158, Service de Pneumologie et Réanimation, GH Pitié-Salpêtrière	Paris

Sponsors (1)

Lead Sponsor	Collaborator
Association pour le Développement et l'Organisation de la Recherche en Pneumologie et sur le Sommeil

Country where clinical trial is conducted

France, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	"Immediate unpleasantness" corresponding to A.1 item of the multidimensional dyspnea profile	Measure MDP scores before and after NIV	Change in MDP score between baseline and after 1 hour of NIV