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

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

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.

Study Overview

• Status: Unknown
• Conditions: Obstructive Sleep Apnea
• Intervention / Treatment: Procedure: Oral appliance

• Study Type: Interventional
• Enrollment (Anticipated): 60
• Phase: Not Applicable

Contacts and Locations

Study Locations

• Brazil
  • SP
    • São Paulo, SP, Brazil, 04023-062
      • Recruiting
      • Instituto do Sono/ Associação Fundo de Incentivo a Psicofarmacologia
      • Principal Investigator: Lia Rita A Bittencourt, MD, PhD
      • Contact: Lia Rita A Bittencourt, MD,PhD; Phone Number: 115521490155; Email: lia@psicobio.epm.br
      • Contact: Lia Rita A Bittencourt, MD, PhD; Phone Number: 115521490155; Email: lia@psicobio.epm.br
      • Sub-Investigator: Thays CA Cunha

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 25 years to 65 years (Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: Male

Description

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)

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Interventional Model: Parallel Assignment
• Masking: Single

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Objective sleep parameters	polysomnographic date of sleep stages percentages, sleep efficience, arousals, apnea-hypopnea index, oxyhemoglobin saturation	two months after the baseline recording

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Subjective sleep parameters	Sleep disorders questionnaire, the Epworth Sleepiness Scale, and sleep diaries	two months after the baseline recording
Quality of life, mood, and anthropometric measurements	SF-36, POMS, neck circumference and craniofacial characteristic	two months after the baseline recording

Collaborators and Investigators

• Sponsor: Associacao Fundo de Incentivo a Psicofarmcologia
• Investigators: Principal Investigator: Lia Rita A Bittencourt, MD, PhD, Federal University of São Paulo

Study record dates

Study Major Dates

• Study Start: October 1, 2010
• Primary Completion (Anticipated): November 1, 2011

Study Registration Dates

• First Submitted: April 14, 2011
• First Submitted That Met QC Criteria: April 14, 2011
• First Posted (Estimate): April 18, 2011

Study Record Updates

• Last Update Posted (Estimate): October 26, 2011
• Last Update Submitted That Met QC Criteria: October 25, 2011
• Last Verified: October 1, 2011

More Information

Terms related to this study

• Keywords: Continuous positive airway pressure; Obstructive Sleep Apnea Syndrome; Snore; Oral appliance
• Additional Relevant MeSH Terms: Nervous System Diseases; Respiratory Tract Diseases; Respiration Disorders; Sleep Disorders, Intrinsic; Dyssomnias; Sleep Wake Disorders; Signs and Symptoms, Respiratory; Sleep Apnea Syndromes; Sleep Apnea, Obstructive; Apnea
• Other Study ID Numbers: 0352/09T