Titration of Continuous Positive Airway Pressure Could Predict Success of Oral Appliance to Treat Sleep Apnea
|ClinicalTrials.gov Identifier: NCT01336556|
Recruitment Status : Unknown
Verified October 2011 by Prof. Dr. Lia Azeredo-Bittencourt, Associacao Fundo de Incentivo a Psicofarmcologia.
Recruitment status was: Recruiting
First Posted : April 18, 2011
Last Update Posted : October 26, 2011
Background: The oral appliances have been increasingly used in the treatment of primary snoring and in patients with mild obstructive sleep apnea syndrome besides being treatment options in adults with moderate to severe sleep apnea who did not accept or adapt to continuous positive airway pressure (CPAP). It is not well established yet in the literature, which patients with mild to moderate OSA will present a good response to treatment with oral appliances.
Objective: To determine a value of CPAP pressure that correlates with a favorable response to the use of oral appliance in patients with mild to moderate sleep apnea.
Patients and Methods: Two groups of 30 male patients (25-65 years, body mass index < 35 kg/m2) will be selected: the first group with an apnea-hypopnea index (AHI) between 5 and 15 events per hour of sleep and the second one with an AHI between 15 and 30 events per hour of sleep. Each patient will undergo three polysomnographic recordings (baseline, CPAP titration, after two months of treatment with oral appliance). Subjective (sleep disorders questionnaire, the Epworth Sleepiness Scale, and sleep diaries) and objective (polysomnography) parameters of sleep will be evaluated, besides the quality of life (SF-36), mood (POMS), and anthropometric measurements (neck circumference and craniofacial characteristic). Good response to treatment with the AIO will be considered as a 50% reduction in the baseline AHI index or AHI after treatment less than 5 events per hour of sleep.
|Condition or disease||Intervention/treatment||Phase|
|Obstructive Sleep Apnea||Procedure: Oral appliance||Not Applicable|
|Study Type :||Interventional (Clinical Trial)|
|Estimated Enrollment :||60 participants|
|Intervention Model:||Parallel Assignment|
|Official Title:||Optimal Titration of Continuous Positive Airway Pressure Could Predict Success of Oral Appliance to Treat Obstructive Sleep Apnea Syndrome|
|Study Start Date :||October 2010|
|Estimated Primary Completion Date :||November 2011|
Procedure: Oral appliance
- Objective sleep parameters [ Time Frame: two months after the baseline recording ]polysomnographic date of sleep stages percentages, sleep efficience, arousals, apnea-hypopnea index, oxyhemoglobin saturation
- Subjective sleep parameters [ Time Frame: two months after the baseline recording ]Sleep disorders questionnaire, the Epworth Sleepiness Scale, and sleep diaries
- Quality of life, mood, and anthropometric measurements [ Time Frame: two months after the baseline recording ]SF-36, POMS, neck circumference and craniofacial characteristic
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT01336556
|Contact: Thays CA Cunhaemail@example.com|
|Instituto do Sono/ Associação Fundo de Incentivo a Psicofarmacologia||Recruiting|
|São Paulo, SP, Brazil, 04023-062|
|Contact: Lia Rita A Bittencourt, MD,PhD 115521490155 firstname.lastname@example.org|
|Contact: Lia Rita A Bittencourt, MD, PhD 115521490155 email@example.com|
|Principal Investigator: Lia Rita A Bittencourt, MD, PhD|
|Sub-Investigator: Thays CA Cunha|
|Principal Investigator:||Lia Rita A Bittencourt, MD, PhD||Federal University of São Paulo|