Calibration of a New Reflectance Oximeter. (PATCHSANTESpO2)

Grenoble Alpes University Hospital Center (CHU)

Status: Completed

Conditions: Healthy Volunteer

Treatments: Device: Calibrate the oximeter ALTITRAINER200®

Study type: Interventional

Funder types: Other

Identifiers

NCT02842255

38RC15.098

Details and patient eligibility

About

This study is about the development of a new medical device for the monitoring of of sleep disordered breathing. This device is developed by the CEA-LETI-LE2S and will be composed of an oximeter, an actimeter in order to measure the activity level of the subject, his state of sleeplessness/sleep, and a CO2 partial pressure transcutaneous sensor (PtcCO2).

Developing this device is realized in several steps : a study (ALMOST) is already in progress and its goal is to acquire a database of polysomnography to create automatic algorithms in order to detect respiratory disorders with this device under development.

The main goal of the study is to calibrate the oxymeter under development.

Enrollment: 10 patients

Sex: All

Ages: 18 to 50 years old

Volunteers: Accepts Healthy Volunteers

Inclusion criteria

• Subjects (both gender) aged between 18 to 50 years affiliated to a certain social security, that has given their free consent to participate to the study
• Subjets without any pathology known and not under medical treatment likely to suffer from controlled hypoxia at levels demanded in the protocol.
• Subjets having a regular practice of sport

Exclusion criteria

• Subjet non affiliated to a certain social security
• Smoker or person exposed to passive smoking
• History of acute mountain sickness or known sensitivity to hypoxia
• Any chronic pathology known, in particular pathologies behind high rates of methaemoglobin
• Pregnant, parturient or breastfeeding women, person deprived of liberty by judicial or administrative decision, person under a legally protected order and could'nt be included in clinical trials (persons mentioned in L1121-5 to L1121-8 of CSP).
• Subjets likely to not be cooperative or respectful of the inherent constraints to study participation.

Trial design

10 participants in 1 patient group

Healthy volunteers

Experimental group

Treatment:

Device: Calibrate the oximeter ALTITRAINER200®