Pharyngeal Sensitivity in Diagnosis Algorithm for Sleep Apnea Syndrome
NCT ID: NCT00885573
Last Updated: 2014-05-05
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
52 participants
INTERVENTIONAL
2008-12-31
2012-12-31
Brief Summary
Review the sponsor-provided synopsis that highlights what the study is about and why it is being conducted.
Related Clinical Trials
Explore similar clinical trials based on study characteristics and research focus.
The PREDICTOR Study: Assessing Diagnostic Predictors of Airway Collapse in Patients With Obstructive Sleep Apnea
NCT05428839
Identify Patients at Risk of Moderate or Severe OSA During ENT Examination
NCT05808868
Efficacy of an Intranasal Stent on Nasal Obstruction at Night
NCT04228016
Nasal Airway Stent (Nastent®) Study in OSA
NCT04305964
Effectiveness of VistaO2 Device in Screening of Sleep Apnea/Hypopnea Syndrome
NCT01135303
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
DIAGNOSTIC
TRIPLE
Study Groups
Review each arm or cohort in the study, along with the interventions and objectives associated with them.
Sleep apnea subjects
Patients with suspected sleep apnea syndrome will have nocturnal polysomnography. According to the number of respiratory events per hour of sleep, patients will be classified as "sleep apnea" or "controls". All the patients will be blindly assessed for pharyngeal sensitivity the morning following the nocturnal recording.
Measurement of pharyngeal sensitivity (SENSITEST)
Measurement of pharyngeal sensitivity using the SENSITEST the morning following the nocturnal polysomnographic recording to diagnose sleep disordered breathing.
Interventions
Learn about the drugs, procedures, or behavioral strategies being tested and how they are applied within this trial.
Measurement of pharyngeal sensitivity (SENSITEST)
Measurement of pharyngeal sensitivity using the SENSITEST the morning following the nocturnal polysomnographic recording to diagnose sleep disordered breathing.
Eligibility Criteria
Check the participation requirements, including inclusion and exclusion rules, age limits, and whether healthy volunteers are accepted.
Inclusion Criteria
* patients who have signed the informed consent form
* patients with body mass index less than or equal 30 kg/m2
Exclusion Criteria
* pharyngeal infection or allergic rhinitis less than 2 weeks before recordings
* craniofacial anomalies and/or limited mouth opening and/or teeth position compromising mouthpiece installation and stability during measurement
* instable dentures
* exaggerated gag reflex preventing pharynx examination
* no visibility of the soft palate
* systemic or topical anti-inflammatory treatments
* treatments that may increase the occurence of nocturnal respiratory events and/or leading to daytime sleepiness and cognitive impairment
* cardiac failure, or symptoms suggesting cardiac failure
* history of stroke
* contraindication for using xylocaine spray
* no affiliation to national insurance
* patient participating in another research study involving drugs that may interfere with sleep recordings and/or measurement of pharyngeal sensation
* patient subjected to exclusion period following participation in another research study
30 Years
65 Years
MALE
No
Sponsors
Meet the organizations funding or collaborating on the study and learn about their roles.
University of Liege
OTHER
Poitiers University Hospital
OTHER
University Hospital, Geneva
OTHER
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.
Maurice DEMATTEIS, MD, PhD
Role: PRINCIPAL_INVESTIGATOR
University Hospital, Grenoble
Locations
Explore where the study is taking place and check the recruitment status at each participating site.
Annemasse-Bonneville Hospital
Annemasse, , France
University Hospital of Grenoble
Grenoble, , France
Clinic of Louvière
Lille, , France
Poitiers University Hospital
Poitiers, , France
University Hospital of Geneva
Geneva, , Switzerland
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.
Dematteis M, Levy P, Pepin JL. A simple procedure for measuring pharyngeal sensitivity: a contribution to the diagnosis of sleep apnoea. Thorax. 2005 May;60(5):418-26. doi: 10.1136/thx.2003.015032.
Larsson H, Carlsson-Nordlander B, Lindblad LE, Norbeck O, Svanborg E. Temperature thresholds in the oropharynx of patients with obstructive sleep apnea syndrome. Am Rev Respir Dis. 1992 Nov;146(5 Pt 1):1246-9. doi: 10.1164/ajrccm/146.5_Pt_1.1246.
Kimoff RJ, Sforza E, Champagne V, Ofiara L, Gendron D. Upper airway sensation in snoring and obstructive sleep apnea. Am J Respir Crit Care Med. 2001 Jul 15;164(2):250-5. doi: 10.1164/ajrccm.164.2.2010012.
Guilleminault C, Li K, Chen NH, Poyares D. Two-point palatal discrimination in patients with upper airway resistance syndrome, obstructive sleep apnea syndrome, and normal control subjects. Chest. 2002 Sep;122(3):866-70. doi: 10.1378/chest.122.3.866.
Woodson BT, Garancis JC, Toohill RJ. Histopathologic changes in snoring and obstructive sleep apnea syndrome. Laryngoscope. 1991 Dec;101(12 Pt 1):1318-22. doi: 10.1002/lary.5541011211.
Friberg D. Heavy snorer's disease: a progressive local neuropathy. Acta Otolaryngol. 1999;119(8):925-33. doi: 10.1080/00016489950180306.
Boyd JH, Petrof BJ, Hamid Q, Fraser R, Kimoff RJ. Upper airway muscle inflammation and denervation changes in obstructive sleep apnea. Am J Respir Crit Care Med. 2004 Sep 1;170(5):541-6. doi: 10.1164/rccm.200308-1100OC. Epub 2004 May 19.
Mayer P, Dematteis M, Pepin JL, Wuyam B, Veale D, Vila A, Levy P. Peripheral neuropathy in sleep apnea. A tissue marker of the severity of nocturnal desaturation. Am J Respir Crit Care Med. 1999 Jan;159(1):213-9. doi: 10.1164/ajrccm.159.1.9709051.
Deegan PC, McNicholas WT. Pathophysiology of obstructive sleep apnoea. Eur Respir J. 1995 Jul;8(7):1161-78. doi: 10.1183/09031936.95.08071161.
Young T, Palta M, Dempsey J, Skatrud J, Weber S, Badr S. The occurrence of sleep-disordered breathing among middle-aged adults. N Engl J Med. 1993 Apr 29;328(17):1230-5. doi: 10.1056/NEJM199304293281704.
Other Identifiers
Review additional registry numbers or institutional identifiers associated with this trial.
2008-A00451-54
Identifier Type: REGISTRY
Identifier Source: secondary_id
0808
Identifier Type: -
Identifier Source: org_study_id
More Related Trials
Additional clinical trials that may be relevant based on similarity analysis.