- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT03753386
Identification of Respiratory Profiles From Nasal Pressure Signals (IPR-SAINS)
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.
Study Overview
Study Type
Enrollment (Actual)
Phase
- Not Applicable
Contacts and Locations
Study Locations
-
-
-
Paris, France, 75013
- INSERM-UPC UMR_S 1158, Service de Pneumologie et Réanimation, GH Pitié-Salpêtrière
-
-
Participation Criteria
Eligibility Criteria
Ages Eligible for Study
Accepts Healthy Volunteers
Genders Eligible for Study
Description
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
Study Plan
How is the study designed?
Design Details
- Primary Purpose: Basic Science
- Allocation: N/A
- Interventional Model: Single Group Assignment
- Masking: None (Open Label)
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
---|---|
Experimental: Healthy subjects
Subjects not presenting any pulmonary pathology that will follow the intervention 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:
Recordings will be retrieved after each test. |
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
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).
|
10 Hz for 30 minutes
|
Collaborators and Investigators
Sponsor
Collaborators
Investigators
- Principal Investigator: Jesus Gonzalez-Bermejo, Groupe Hospitalier Pitie-Salpetriere
Publications and helpful links
Study record dates
Study Major Dates
Study Start (Actual)
Primary Completion (Actual)
Study Completion (Actual)
Study Registration Dates
First Submitted
First Submitted That Met QC Criteria
First Posted (Actual)
Study Record Updates
Last Update Posted (Actual)
Last Update Submitted That Met QC Criteria
Last Verified
More Information
Terms related to this study
Other Study ID Numbers
- 2018-A01999-46
Drug and device information, study documents
Studies a U.S. FDA-regulated drug product
Studies a U.S. FDA-regulated device product
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
Clinical Trials on Healthy
-
Prevent Age Resort "Pervaya Liniya"RecruitingHealthy Aging | Healthy Diet | Healthy LifestyleRussian Federation
-
Maastricht University Medical CenterCompletedHealthy Volunteers | Healthy Subjects | Healthy AdultsNetherlands
-
Yale UniversityNot yet recruitingHealth-related Benefits of Introducing Table Olives Into the Diet of Young Adults: Olives For HealthHealthy Diet | Healthy Lifestyle | Healthy Nutrition | CholesterolUnited States
-
Hasselt UniversityRecruitingHealthy | Healthy AgingBelgium
-
Galera Therapeutics, Inc.Syneos HealthCompleted
-
Galera Therapeutics, Inc.Syneos HealthCompletedHealthy | Healthy VolunteersAustralia
-
University of PennsylvaniaActive, not recruitingHealthy | Healthy AgingUnited States
-
Chalmers University of TechnologyGöteborg UniversityCompletedHealthy | Nutrition, HealthySweden
-
University of ManitobaNot yet recruitingHealthy | Healthy Diet
Clinical Trials on Oxygen therapy simulation
-
Direction Centrale du Service de Santé des ArméesRecruitingDecompression SicknessFrance
-
Bayside HealthMonash University; Baker Heart and Diabetes Institute; Ambulance Victoria; FALCK...UnknownCoronary Artery Disease | Acute Myocardial InfarctionAustralia
-
University of Wisconsin, MadisonActive, not recruitingStage II Prostate Adenocarcinoma | Stage I Prostate AdenocarcinomaUnited States
-
Jonsson Comprehensive Cancer CenterNational Cancer Institute (NCI)CompletedGlioblastoma | Recurrent Brain NeoplasmUnited States
-
Aalborg University HospitalUniversity of AarhusUnknownCardiac Surgery | Cardiopulmonary Bypass | Acute Lung Injury | Hyperoxia | Oxygen ToxicityDenmark
-
Cairo UniversityActive, not recruiting
-
The First Affiliated Hospital of Zhejiang Chinese...Not yet recruitingCOVID-19 | Cognitive Decline | SARS CoV 2 InfectionChina
-
Monash UniversityRecruitingFibrotic Interstitial Lung DiseaseAustralia
-
Ain Shams UniversityRecruitingOxygen Therapy | Pulmonary ResectionEgypt
-
UMC UtrechtThe Netherlands Cancer InstituteCompletedBreast Cancer | Radiation ToxicityNetherlands