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

NCT01336556 · Status: UNKNOWN · Phase: NA · Type: INTERVENTIONAL · Enrollment: 60

Last updated 2011-10-26

No results posted yet for this study

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

Interventions

PROCEDURE

Oral appliance

Anterior mandibular repositioner: used for two months

Sponsors & Collaborators

  • Associacao Fundo de Incentivo a Psicofarmcologia

    lead OTHER

Principal Investigators

  • Lia Rita A Bittencourt, MD, PhD · Federal University of São Paulo

Study Design

Purpose
TREATMENT
Masking
SINGLE
Model
PARALLEL

Eligibility

Min Age
25 Years
Max Age
65 Years
Sex
MALE
Healthy Volunteers
No

Timeline & Regulatory

Start
2010-10-31
Primary Completion
2011-11-30

Countries

  • Brazil

Study Locations

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Entities

Diseases

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT01336556 on ClinicalTrials.gov