Calibration of a New Reflectance Oximeter.

NCT02842255 | Completed

• 1 other identifier: 38RC15.098
• Study Type: interventional
• Target: 10
• Locations: 1 country
• Sites: 1

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.

Conditions

Healthy Volunteer

Keywords

Sleep apnea; Oximeter; Calibration; Oxygen partial pressure

Outcome Measures

Primary Outcomes (2)

• Calibration of the oximeter in normoxic situation

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

  2 hours

• 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

Study Arms (1)

Healthy volunteers

EXPERIMENTAL

Device: Calibrate the oximeter ALTITRAINER200®

Interventions

Calibrate the oximeter ALTITRAINER200® DEVICE

During normoxic condition and four situations of hypoxia.

Healthy volunteers

Eligibility Criteria

• Age: 18 Years - 50 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64)

You may qualify if:

• 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

You may not qualify if:

• 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.

Sponsors & Collaborators

• University Hospital, Grenoble: lead

Study Sites (1)

UniversityHospitalGrenoble

La Tronche, 38700, France

Location

Related Publications (12)

• 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.

  PMID: 23066376 BACKGROUND

• 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.

  PMID: 20086074 BACKGROUND

• 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.

  PMID: 17218569 BACKGROUND

• 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.

  PMID: 9872827 BACKGROUND

• 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.

  PMID: 10805822 BACKGROUND

• 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.

  PMID: 14694494 BACKGROUND

• 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.

  PMID: 9700127 BACKGROUND

• 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.

  PMID: 25031547 BACKGROUND

• 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.

  PMID: 20493971 BACKGROUND

• 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.

  PMID: 22071330 BACKGROUND

• 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.

  PMID: 17323073 BACKGROUND

• 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.

  PMID: 21397053 BACKGROUND

MeSH Terms

Conditions

Sleep Apnea Syndromes

Condition Hierarchy (Ancestors)

Apnea; Respiration Disorders; Respiratory Tract Diseases; Sleep Disorders, Intrinsic; Dyssomnias; Sleep Wake Disorders; Nervous System Diseases

Study Officials

• Bernard Wuyam, Doctor

  Grenoble Hospital University

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NA
• Masking: NONE
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: July 20, 2016
• First Posted: July 22, 2016
• Study Start: October 1, 2015
• Primary Completion: January 1, 2016
• Study Completion: January 1, 2016
• Last Updated: July 22, 2016

Record last verified: 2016-07

Locations

FR (1)