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CompletedNCT02842255PATCHSANTESpO2Updated Jul 22, 2016

Calibration of a New Reflectance Oximeter.

An interventional study of Calibrate the oximeter ALTITRAINER200® in Healthy Volunteer, sponsored by University Hospital, Grenoble. Completed at 1 site in France. Open to participants aged 18 Years to 50 Years, including healthy volunteers. Per ClinicalTrials.gov, last updated 2016-07-22.

Sponsored by University Hospital, Grenoble · Not applicable and Interventional

Phase
Not applicable
Study type
Interventional
Enrollment
10
Allocation
Not applicable
Ages
18 Years to 50 Years
Sex
All
01

Study 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.

02

Conditions studied

  • Healthy Volunteer

Keywords

  • Sleep apnea
  • Oximeter
  • Calibration
  • Oxygen partial pressure
03

In context

Lead sponsor

University Hospital, Grenoble is the lead sponsor of 815 studies on the registry; 205 are open to participants now.

Counted across the registry records on this site, refreshed daily.

04

Who can participate

Ages eligible
18 Years to 50 Years
Sexes eligible
All
Accepts healthy volunteers
Yes

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

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.
05

Study design

Phase
Not applicable
Allocation
Not applicable
Intervention model
Single group
Masking
None (open label)
Enrollment
10 participants (actual)

Study arms

  • Experimental
    Healthy volunteers

    Device: Calibrate the oximeter ALTITRAINER200®

Interventions

  • DeviceCalibrate the oximeter ALTITRAINER200®

    During normoxic condition and four situations of hypoxia.

06

What researchers measure

Primary outcomes

  1. Calibration of the oximeter in normoxic situation

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

    Time frame: 2 hours

  2. 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

    Time frame: 2 hours

07

Study locations

1 site
  • UniversityHospitalGrenoble
    La Tronche, 38700, France
08

References and documents

Publications

  • Berry RB, Budhiraja R, Gottlieb DJ, Gozal D, Iber C, Kapur VK, Marcus CL, Mehra R, Parthasarathy S, Quan SF, Redline S, Strohl KP, Davidson Ward SL, Tangredi MM; American Academy of Sleep Medicine. Rules for scoring respiratory events in sleep: update of the 2007 AASM Manual for the Scoring of Sleep and Associated Events. Deliberations of the Sleep Apnea Definitions Task Force of the American Academy of Sleep Medicine. J Clin Sleep Med. 2012 Oct 15;8(5):597-619. doi: 10.5664/jcsm.2172. PubMed 23066376 ↗
  • Dempsey JA, Veasey SC, Morgan BJ, O'Donnell CP. Pathophysiology of sleep apnea. Physiol Rev. 2010 Jan;90(1):47-112. doi: 10.1152/physrev.00043.2008. Erratum In: Physiol Rev.2010 Apr;90(2):797-8. PubMed 20086074 ↗
  • Chouri-Pontarollo N, Borel JC, Tamisier R, Wuyam B, Levy P, Pepin JL. Impaired objective daytime vigilance in obesity-hypoventilation syndrome: impact of noninvasive ventilation. Chest. 2007 Jan;131(1):148-55. doi: 10.1378/chest.06-1159. PubMed 17218569 ↗
  • Becker HF, Piper AJ, Flynn WE, McNamara SG, Grunstein RR, Peter JH, Sullivan CE. Breathing during sleep in patients with nocturnal desaturation. Am J Respir Crit Care Med. 1999 Jan;159(1):112-8. doi: 10.1164/ajrccm.159.1.9803037. PubMed 9872827 ↗
  • Peppard PE, Young T, Palta M, Skatrud J. Prospective study of the association between sleep-disordered breathing and hypertension. N Engl J Med. 2000 May 11;342(19):1378-84. doi: 10.1056/NEJM200005113421901. PubMed 10805822 ↗
  • Perrin C, Unterborn JN, Ambrosio CD, Hill NS. Pulmonary complications of chronic neuromuscular diseases and their management. Muscle Nerve. 2004 Jan;29(1):5-27. doi: 10.1002/mus.10487. PubMed 14694494 ↗
  • Flemons WW, Reimer MA. Development of a disease-specific health-related quality of life questionnaire for sleep apnea. Am J Respir Crit Care Med. 1998 Aug;158(2):494-503. doi: 10.1164/ajrccm.158.2.9712036. PubMed 9700127 ↗
  • Nitzan M, Romem A, Koppel R. Pulse oximetry: fundamentals and technology update. Med Devices (Auckl). 2014 Jul 8;7:231-9. doi: 10.2147/MDER.S47319. eCollection 2014. PubMed 25031547 ↗
  • Mollard P, Bourdillon N, Letournel M, Herman H, Gibert S, Pichon A, Woorons X, Richalet JP. Validity of arterialized earlobe blood gases at rest and exercise in normoxia and hypoxia. Respir Physiol Neurobiol. 2010 Jul 31;172(3):179-83. doi: 10.1016/j.resp.2010.05.017. Epub 2010 May 21. PubMed 20493971 ↗
  • Richalet JP, Larmignat P, Poitrine E, Letournel M, Canoui-Poitrine F. Physiological risk factors for severe high-altitude illness: a prospective cohort study. Am J Respir Crit Care Med. 2012 Jan 15;185(2):192-8. doi: 10.1164/rccm.201108-1396OC. Epub 2011 Oct 27. PubMed 22071330 ↗
  • Savourey G, Launay JC, Besnard Y, Guinet-Lebreton A, Alonso A, Sauvet F, Bourrilhon C. Normo or hypobaric hypoxic tests: propositions for the determination of the individual susceptibility to altitude illnesses. Eur J Appl Physiol. 2007 May;100(2):193-205. doi: 10.1007/s00421-007-0417-8. Epub 2007 Feb 24. PubMed 17323073 ↗
  • Aguilaniu B, Maitre J, Diab S, Perrault H, Peronnet F. Detection of disturbances in pulmonary gas exchanges during exercise from arterialized earlobe PO2. Respir Physiol Neurobiol. 2011 Jun 30;177(1):30-5. doi: 10.1016/j.resp.2011.03.005. Epub 2011 Mar 17. PubMed 21397053 ↗
09

Updates

Tracking since Sep 25, 2026
No changes since tracking began. The registry record was last updated on Jul 22, 2016, before this site started recording changes on Sep 25, 2026. Its history is on ClinicalTrials.gov ↗
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Registry details

Key details

Study ID
NCT02842255
Lead sponsor
University Hospital, Grenoble
Responsible party
Sponsor
First posted
Jul 22, 2016
Start date
Oct 2015
Primary completion
Jan 2016
Completion
Jan 2016
Last update
Jul 22, 2016

Study contacts

Bernard Wuyam, Doctor
principal investigator · Grenoble Hospital University

Oversight

Data monitoring committee
No
View the source record on ClinicalTrials.gov ↗

Not currently enrolling

This study is completed, as verified in Jul 2016. You cannot join it, but the record below documents what was studied.

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