Calibration of a New Reflectance Oximeter.

Study Overview
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Brief Summary
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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.

Official Title
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Calibration of a New Reflectance Oximeter.

Conditions
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Healthy Volunteer

Intervention / Treatment
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* Device: Calibrate the oximeter ALTITRAINER200®


Participation Criteria
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Eligibility Criteria
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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.

Ages Eligible for Study
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Minimum Age: 18 Years
Maximum Age: 50 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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Accepts Healthy Volunteers

Study Plan
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How is the study designed?
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Design Details

Intervention Model: Single Group Assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Healthy volunteers<br> | Device: Calibrate the oximeter ALTITRAINER200®<br>* During normoxic condition and four situations of hypoxia.<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Calibration of the oximeter in normoxic situation | Measures with ALTITRAINER200® system Ambiant air : 98-96 % partial pressure in O2 | 2 hours | 
| Calibration of the oximeter in hypoxia situation | 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 | 2 hours | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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Sleep apnea, Oximeter, Calibration, Oxygen partial pressure