Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
Get a concise snapshot of the trial, including recruitment status, study phase, enrollment targets, and key timeline milestones.
COMPLETED
NA
10 participants
INTERVENTIONAL
2015-10-31
2016-01-31
Brief Summary
Review the sponsor-provided synopsis that highlights what the study is about and why it is being conducted.
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.
Related Clinical Trials
Explore similar clinical trials based on study characteristics and research focus.
The Accuracy of the Dormotech VLAB During Stable Hypoxia Plateaus
NCT06516809
ECG Derived Respiration for Automated Screening of Sleep Disordered Breathing in Chronic Heart Failure Patients
NCT02116686
Validation of the Respiratory Function of Pulmonary Transplants to Anticipate Unplanned Hospitalizations
NCT03368365
Early Identification of Clinical Deterioration Using a Wearable Monitoring Device
NCT04220359
Communication Enhancement Among Ventilated Patients in Intensive Care
NCT07251530
Detailed Description
Dive into the extended narrative that explains the scientific background, objectives, and procedures in greater depth.
Conditions
See the medical conditions and disease areas that this research is targeting or investigating.
Study Design
Understand how the trial is structured, including allocation methods, masking strategies, primary purpose, and other design elements.
NA
SINGLE_GROUP
NONE
Study Groups
Review each arm or cohort in the study, along with the interventions and objectives associated with them.
Healthy volunteers
Calibrate the oximeter ALTITRAINER200®
During normoxic condition and four situations of hypoxia.
Interventions
Learn about the drugs, procedures, or behavioral strategies being tested and how they are applied within this trial.
Calibrate the oximeter ALTITRAINER200®
During normoxic condition and four situations of hypoxia.
Eligibility Criteria
Check the participation requirements, including inclusion and exclusion rules, age limits, and whether healthy volunteers are accepted.
Inclusion Criteria
* 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
* 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.
18 Years
50 Years
ALL
Yes
Sponsors
Meet the organizations funding or collaborating on the study and learn about their roles.
University Hospital, Grenoble
OTHER
Responsible Party
Identify the individual or organization who holds primary responsibility for the study information submitted to regulators.
Principal Investigators
Learn about the lead researchers overseeing the trial and their institutional affiliations.
Bernard Wuyam, Doctor
Role: PRINCIPAL_INVESTIGATOR
Grenoble Hospital University
Locations
Explore where the study is taking place and check the recruitment status at each participating site.
UniversityHospitalGrenoble
La Tronche, , France
Countries
Review the countries where the study has at least one active or historical site.
References
Explore related publications, articles, or registry entries linked to this study.
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.
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.
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.
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.
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.
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.
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.
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.
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.
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.
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.
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.
Other Identifiers
Review additional registry numbers or institutional identifiers associated with this trial.
38RC15.098
Identifier Type: -
Identifier Source: org_study_id
More Related Trials
Additional clinical trials that may be relevant based on similarity analysis.