Now Available for Public Comment: Notice of Proposed Rulemaking (NPRM) for FDAAA 801 and NIH Draft Reporting Policy for NIH-Funded Trials

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

April 14, 2011
October 25, 2011
October 2010
November 2011   (final data collection date for primary outcome measure)
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
Same as current
Complete list of historical versions of study NCT01336556 on ClinicalTrials.gov Archive Site
  • 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
Same as current
Not Provided
Not Provided
 
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.

Not Provided
Interventional
Not Provided
Intervention Model: Parallel Assignment
Masking: Single Blind (Investigator)
Primary Purpose: Treatment
Obstructive Sleep Apnea
Procedure: Oral appliance
Anterior mandibular repositioner: used for two months
Not Provided
Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruiting
60
Not Provided
November 2011   (final data collection date for primary outcome measure)

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)
Male
25 Years to 65 Years
No
Contact: Thays CA Cunha 551121490155 thayscrosara@gmail.com
Brazil
 
NCT01336556
0352/09T
Yes
Prof. Dr. Lia Azeredo-Bittencourt, Associacao Fundo de Incentivo a Psicofarmcologia
Associacao Fundo de Incentivo a Psicofarmcologia
Not Provided
Principal Investigator: Lia Rita A Bittencourt, MD, PhD Federal University of São Paulo
Associacao Fundo de Incentivo a Psicofarmcologia
October 2011

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP