Calibration of a New Reflectance Oximeter.

Not Applicable

Completed

• Conditions: Healthy Volunteer
• Interventions: Device: Calibrate the oximeter ALTITRAINER200®

• Registration Number: NCT02842255
• Lead Sponsor: University Hospital, Grenoble

Brief Summary

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.

Detailed Description

Not available

Study Timeline

• Study Start: 2015-10
• Primary Completion: 2016-01
• Study Completion: 2016-01
• Status Verified: 2016-07
• Study First Submitted: 2016-07-20
• Study First Submitted QC: 2016-07-20
• Last Update Submitted: 2016-07-20
• Study First Posted: 2016-07-22
• Last Update Posted: 2016-07-22

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 10

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.

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: SINGLE_GROUP

Arm && Interventions

Group	Intervention	Description
Healthy volunteers	Calibrate the oximeter ALTITRAINER200®	-

Primary Outcome Measures

Name	Time	Method
Calibration of the oximeter in normoxic situation	2 hours	Measures with ALTITRAINER200® system Ambiant air : 98-96 % partial pressure in O2
Calibration of the oximeter in hypoxia situation	2 hours	Measures with ALTITRAINER200® system Situation 1 : 90 % (92-88%) partial pressure in O2 Situation 2 : 85% (87-83%) partial pressure in O2 Situation 3 : 80% (82-78%) partial pressure in O2 Situation 4 : 75%(77%-73%) partial pressure in O2

Trial Locations

Locations (1)

UniversityHospitalGrenoble; 🇫🇷 La Tronche, France