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

The recruitment status of this study is unknown because the information has not been verified recently.
Verified October 2011 by Associacao Fundo de Incentivo a Psicofarmcologia.
Recruitment status was  Recruiting
Sponsor:
Information provided by (Responsible Party):
Prof. Dr. Lia Azeredo-Bittencourt, Associacao Fundo de Incentivo a Psicofarmcologia
ClinicalTrials.gov Identifier:
NCT01336556
First received: April 14, 2011
Last updated: October 25, 2011
Last verified: October 2011
  Purpose

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 Intervention
Obstructive Sleep Apnea
Procedure: Oral appliance

Study Type: Interventional
Study Design: Intervention Model: Parallel Assignment
Masking: Single Blind (Investigator)
Primary Purpose: Treatment
Official Title: Optimal Titration of Continuous Positive Airway Pressure Could Predict Success of Oral Appliance to Treat Obstructive Sleep Apnea Syndrome

Resource links provided by NLM:


Further study details as provided by Associacao Fundo de Incentivo a Psicofarmcologia:

Primary Outcome Measures:
  • Objective sleep parameters [ Time Frame: two months after the baseline recording ] [ Designated as safety issue: No ]
    polysomnographic date of sleep stages percentages, sleep efficience, arousals, apnea-hypopnea index, oxyhemoglobin saturation


Secondary Outcome Measures:
  • Subjective sleep parameters [ Time Frame: two months after the baseline recording ] [ Designated as safety issue: No ]
    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 ] [ Designated as safety issue: No ]
    SF-36, POMS, neck circumference and craniofacial characteristic


Estimated Enrollment: 60
Study Start Date: October 2010
Estimated Primary Completion Date: November 2011 (Final data collection date for primary outcome measure)
Intervention Details:
    Procedure: Oral appliance
    Anterior mandibular repositioner: used for two months
  Eligibility

Ages Eligible for Study:   25 Years to 65 Years
Genders Eligible for Study:   Male
Accepts Healthy Volunteers:   No
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)
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT01336556

Contacts
Contact: Thays CA Cunha 551121490155 thayscrosara@gmail.com

Locations
Brazil
Instituto do Sono/ Associação Fundo de Incentivo a Psicofarmacologia Recruiting
São Paulo, SP, Brazil, 04023-062
Contact: Lia Rita A Bittencourt, MD,PhD    115521490155    lia@psicobio.epm.br   
Contact: Lia Rita A Bittencourt, MD, PhD    115521490155    lia@psicobio.epm.br   
Principal Investigator: Lia Rita A Bittencourt, MD, PhD         
Sub-Investigator: Thays CA Cunha         
Sponsors and Collaborators
Associacao Fundo de Incentivo a Psicofarmcologia
Investigators
Principal Investigator: Lia Rita A Bittencourt, MD, PhD Federal University of São Paulo
  More Information

No publications provided

Responsible Party: Prof. Dr. Lia Azeredo-Bittencourt, professor, Associacao Fundo de Incentivo a Psicofarmcologia
ClinicalTrials.gov Identifier: NCT01336556     History of Changes
Other Study ID Numbers: 0352/09T
Study First Received: April 14, 2011
Last Updated: October 25, 2011
Health Authority: Brazil: National Committee of Ethics in Research

Keywords provided by Associacao Fundo de Incentivo a Psicofarmcologia:
Oral appliance
Continuous positive airway pressure
Obstructive Sleep Apnea Syndrome
Snore

Additional relevant MeSH terms:
Apnea
Sleep Apnea Syndromes
Sleep Apnea, Obstructive
Respiration Disorders
Respiratory Tract Diseases
Signs and Symptoms, Respiratory
Signs and Symptoms
Sleep Disorders, Intrinsic
Dyssomnias
Sleep Disorders
Nervous System Diseases

ClinicalTrials.gov processed this record on July 22, 2014