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Trial record 11 of 619 for:    oximeter

Calibration of a New Reflectance Oximeter. (PATCHSANTESpO2)

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ClinicalTrials.gov Identifier: NCT02842255
Recruitment Status : Completed
First Posted : July 22, 2016
Last Update Posted : July 22, 2016
Sponsor:
Information provided by (Responsible Party):
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.


Condition or disease Intervention/treatment Phase
Healthy Volunteer Device: Calibrate the oximeter ALTITRAINER200® Not Applicable

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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

Arm Intervention/treatment
Experimental: Healthy volunteers Device: Calibrate the oximeter ALTITRAINER200®
During normoxic condition and four situations of hypoxia.




Primary Outcome Measures :
  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



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Ages Eligible for Study:   18 Years to 50 Years   (Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   Yes
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.

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT02842255


Locations
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France
UniversityHospitalGrenoble
La Tronche, France, 38700
Sponsors and Collaborators
University Hospital, Grenoble
Investigators
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Principal Investigator: Bernard Wuyam, Doctor Grenoble Hospital University

Publications:

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Responsible Party: University Hospital, Grenoble
ClinicalTrials.gov Identifier: NCT02842255     History of Changes
Other Study ID Numbers: 38RC15.098
First Posted: July 22, 2016    Key Record Dates
Last Update Posted: July 22, 2016
Last Verified: July 2016
Keywords provided by University Hospital, Grenoble:
Sleep apnea
Oximeter
Calibration
Oxygen partial pressure