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OpenTrials
Completed

NCT Number: NCT02842255

Calibration of a New Reflectance Oximeter.

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.

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Key information

Conditions

Healthy Volunteer Apnea Dyssomnias Nervous System Diseases Respiration Disorders Respiratory Tract Diseases Sleep Apnea Syndromes Sleep Disorders, Intrinsic Sleep Wake Disorders

Age range

18 year–50 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

UniversityHospitalGrenoble

La Tronche, 38700, France

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

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.

Treatment and study plan

Calibrate the oximeter ALTITRAINER200®

Device

During normoxic condition and four situations of hypoxia.

Primary outcomes

  1. Calibration of the oximeter in normoxic situation

    Time frame: 2 hours

    Measures with ALTITRAINER200® system Ambiant air : 98-96 % partial pressure in O2

  2. 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

Sponsors and collaborators

Lead sponsor

University Hospital, Grenoble

Other

Registry information

Acronym: PATCHSANTESpO2

Important dates

Study start
2015
Primary completion
2016
Study completion
2016
First posted
Jul 22, 2016
Registry last updated
Jul 22, 2016

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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