Calibration of a New Reflectance Oximeter. (PATCHSANTESpO2)
|ClinicalTrials.gov Identifier: NCT02842255|
Recruitment Status : Completed
First Posted : July 22, 2016
Last Update Posted : July 22, 2016
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.
|Condition or disease||Intervention/treatment||Phase|
|Healthy Volunteer||Device: Calibrate the oximeter ALTITRAINER200®||Not Applicable|
|Study Type :||Interventional (Clinical Trial)|
|Actual Enrollment :||10 participants|
|Intervention Model:||Single Group Assignment|
|Masking:||None (Open Label)|
|Official Title:||Calibration of a New Reflectance Oximeter.|
|Study Start Date :||October 2015|
|Actual Primary Completion Date :||January 2016|
|Actual Study Completion Date :||January 2016|
|Experimental: Healthy volunteers||
Device: Calibrate the oximeter ALTITRAINER200®
During normoxic condition and four situations of hypoxia.
- Calibration of the oximeter in normoxic situation [ Time Frame: 2 hours ]Measures with ALTITRAINER200® system Ambiant air : 98-96 % partial pressure in O2
- Calibration of the oximeter in hypoxia situation [ Time Frame: 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
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT02842255
|La Tronche, France, 38700|
|Principal Investigator:||Bernard Wuyam, Doctor||Grenoble Hospital University|