Clinical trial NCT02842255: Calibration of a New Reflectance Oximeter.
Official title: Calibration of a New Reflectance Oximeter.
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Healthy Volunteer
Keywords: Sleep apnea
Oximeter
Calibration
Oxygen partial pressure
Lead sponsor: University Hospital, Grenoble
Sponsor class: OTHER
First posted: 2016-07-22
Enrollment: 10
Sex: ALL
Minimum age (years): 18
Maximum age (years): 50
Standard ages: ADULT
Accepts healthy volunteers: yes
Allocation: NA
Intervention model: SINGLE_GROUP

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.


Eligibility criteria: 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.

Primary outcomes:
measure: Calibration of the oximeter in normoxic situation
timeFrame: 2 hours
measure: Calibration of the oximeter in hypoxia situation
timeFrame: 2 hours
Secondary outcomes:
Other outcomes:
Locations:
city: La Tronche
country: France
facility: UniversityHospitalGrenoble
Study officials:
affiliation: Grenoble Hospital University
name: Bernard Wuyam, Doctor
role: PRINCIPAL_INVESTIGATOR
References:
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