Identification of Respiratory Profiles From Nasal Pressure Signals

Healthy Clinical Trial

— IPR-SAINS  

Official title:

Identification of Respiratory Profiles From Nasal Pressure Signals

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT03753386
• Other study ID #: 2018-A01999-46
• Status: Completed
• Phase: N/A
• Start date: May 16, 2019
• Est. completion date: May 28, 2019

Study information

• Verified date: September 2019
• Source: Association pour le Développement et l'Organisation de la Recherche en Pneumologie et sur le Sommeil
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial Summary

Chronic Obstructive Pulmonary Disease (COPD) is a chronic respiratory disease caused by smoking and associated with significant morbidity due to recurrent exacerbations or even hospitalizations. It is one of the leading causes of death in rich countries.

Early detection of exacerbations of the disease is thus an economic and public health issue in the world. Finding tools for automatic and early detection of an exacerbation is the subject of the study. A continuous analysis of the frequency and shape of the patients' breathing will be used.

As a first step in this study, investigators want to measure the frequency and shape of breathing in healthy subjects as they execute standard activities. These activities include resting, drinking, coughing, speaking, breathing through the mouth, physical exercise and recuperation.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 20
• Est. completion date: May 28, 2019
• Est. primary completion date: May 16, 2019
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: All
• Age group: 18 Years to 80 Years

Eligibility

Inclusion Criteria:

• Age of majority

• Health volunteers

Exclusion Criteria:

• Pregnancy

• Age of minority

• Protected adult

• Person deprived of liberty

• Respiratory pathology

• Non affiliation to the health care system

Related Conditions & MeSH terms

• Healthy

Intervention

Other:
• Oxygen therapy simulation
The intervention consists of reproducing oxygen therapy situations in healthy individuals by replacing oxygen bottles with bottles of air. A TeleOx® device will be placed on the circuit between the source and the nasal cannula for respiratory signals recording. The intervention will last 30 minutes, containing the following activities in the given order: rest (9 minutes); drinking water (1 minute); rest (1 minute); coughing (1 minute); rest (1 minute); reading aloud (1 minute); rest (1 minute); breathing by the mouth (1 minute); rest (1 minute); exercising (running) (3 minutes) and rest (10 minutes) Recordings will be retrieved after each test.

Locations

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

Sponsors (2)

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

Country where clinical trial is conducted

France, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Pressure	The monitoring device used records the nasal pressure from users at 10 Hz (one measure every 0.1 seconds).	10 Hz for 30 minutes