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Completed

NCT Number: NCT03753386

Identification of Respiratory Profiles From Nasal Pressure Signals

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.

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Key information

Conditions

Healthy

Age range

18 year–80 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

INSERM-UPC UMR_S 1158, Service de Pneumologie et Réanimation, GH Pitié-Salpêtrière

Paris, 75013, France

Who can participate

Healthy volunteers accepted: Yes

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

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

Treatment and study plan

Oxygen therapy simulation

Other

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.

Primary outcomes

  1. Pressure

    Time frame: 10 Hz for 30 minutes

    The monitoring device used records the nasal pressure from users at 10 Hz (one measure every 0.1 seconds).

Sponsors and collaborators

Lead sponsor

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

Other

Collaborators

  • SRETT

Registry information

Acronym: IPR-SAINS

Important dates

Study start
2019
Primary completion
2019
Study completion
2019
First posted
Nov 27, 2018
Registry last updated
Sep 16, 2019

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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