Titration of Continuous Positive Airway Pressure Could Predict Success of Oral Appliance to Treat Sleep Apnea

NCT ID: NCT01336556

Last Updated: 2011-10-26

Basic Information

• Recruitment Status: UNKNOWN
• Clinical Phase: NA
• Total Enrollment: 60 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2010-10-31

Brief Summary

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.

Conditions

Obstructive Sleep Apnea

Study Design

• Intervention Model: PARALLEL
• Primary Study Purpose: TREATMENT
• Blinding Strategy: SINGLE

Interventions

Oral appliance

Anterior mandibular repositioner: used for two months

Intervention Type: PROCEDURE

Eligibility Criteria

Inclusion Criteria

• Male subjects aged between 25 and 65 years old
• Epworth sleepiness Scale > 9
• Apnea-hypopnea index between 5 and 30

Exclusion Criteria

• Presence of clinical disease (chronic obstructive pulmonary disease, asthma) and other sleep disorders.
• Presence of anatomical obstructive upper airway, tonsil grade III e IV, septal deviation and grade III that may affect the outcome of CPAP
• Loss of posterior dental support to undermine the retention of oral appliance
• Active of periodontal disease, compared Dental crow/dental root less than or equal to 1 (c/r ≤ 1) need primary dental care (cavities, root canal treatment or retreatment, dentures, i.e. outlying), open bite
• Protrusive displacement lass then five millimeters
• Limited mouth opening
• Alcoholism
• Use of sleep-inducing medications
• Habits or occupation that lead to sleep deprivation or alteration of the sleep-wake cycle
• Intolerance to CPAP
• Obesity grade II (moderate) or III (severe)

• Minimum Eligible Age: 25 Years
• Maximum Eligible Age: 65 Years
• Eligible Sex: MALE
• Accepts Healthy Volunteers: No

Sponsors

Associacao Fundo de Incentivo a Psicofarmcologia

OTHER

Sponsor Role: lead

Responsible Party

Prof. Dr. Lia Azeredo-Bittencourt

professor

Responsibility Role: PRINCIPAL_INVESTIGATOR

Principal Investigators

Lia Rita A Bittencourt, MD, PhD

Role: PRINCIPAL_INVESTIGATOR

Federal University of São Paulo

Locations

Instituto do Sono/ Associação Fundo de Incentivo a Psicofarmacologia

São Paulo, São Paulo, Brazil

Site Status: RECRUITING

Countries

Brazil

Central Contacts

Thays CA Cunha

Role: CONTACT

thayscrosara@gmail.com

551121490155

Facility Contacts

Lia Rita A Bittencourt, MD,PhD

Role: primary

lia@psicobio.epm.br

115521490155

Lia Rita A Bittencourt, MD, PhD

Role: backup

lia@psicobio.epm.br

115521490155

Other Identifiers

0352/09T

Identifier Type: -

Identifier Source: org_study_id