Calibration of a New Reflectance Oximeter.

Healthy Volunteer Clinical Trial

— PATCHSANTESpO2  

Official title:

Calibration of a New Reflectance Oximeter.

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT02842255
• Other study ID #: 38RC15.098
• Status: Completed
• Phase: N/A
• First received: July 20, 2016
• Last updated: July 20, 2016
• Start date: October 2015
• Est. completion date: January 2016

Study information

• Verified date: July 2016
• Source: University Hospital, Grenoble
• Contact: n/a
• Is FDA regulated: No
• Health authority: France: Agence Nationale de Sécurité du Médicament et des produits de santé
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 10
• Est. completion date: January 2016
• Est. primary completion date: January 2016
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: Both
• Age group: 18 Years to 50 Years

Eligibility

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.

Study Design

Endpoint Classification: Safety Study, Intervention Model: Single Group Assignment, Masking: Open Label

Related Conditions & MeSH terms

• Healthy Volunteer

Intervention

Device:
• Calibrate the oximeter ALTITRAINER200®
During normoxic condition and four situations of hypoxia.

Locations

Country	Name	City	State
France	UniversityHospitalGrenoble	La Tronche

Sponsors (1)

Lead Sponsor	Collaborator
University Hospital, Grenoble

Country where clinical trial is conducted

France, 

References & Publications (12)

Aguilaniu B, Maitre J, Diab S, Perrault H, Péronnet 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. — View Citation

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. — View Citation

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. — View Citation

Chouri-Pontarollo N, Borel JC, Tamisier R, Wuyam B, Levy P, Pépin JL. Impaired objective daytime vigilance in obesity-hypoventilation syndrome: impact of noninvasive ventilation. Chest. 2007 Jan;131(1):148-55. — View Citation

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. Review. Erratum in: Physiol Rev.2010 Apr;90(2):797-8. — View Citation

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. — View Citation

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. — View Citation

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. Review. — View Citation

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. — View Citation

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. Review. — View Citation

Richalet JP, Larmignat P, Poitrine E, Letournel M, Canouï-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. — View Citation

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. Epub 2007 Feb 24. — View Citation

* Note: There are 12 references in all — Click here to view all references

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Calibration of the oximeter in normoxic situation	Measures with ALTITRAINER200® system Ambiant air : 98-96 % partial pressure in O2	2 hours	No
Primary	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	2 hours	No