Titration of Continuous Positive Airway Pressure Could Predict Success of Oral Appliance to Treat Sleep Apnea
Primary Purpose
Obstructive Sleep Apnea
Status
Unknown status
Phase
Not Applicable
Locations
Brazil
Study Type
Interventional
Intervention
Oral appliance
Sponsored by
About this trial
This is an interventional treatment trial for Obstructive Sleep Apnea focused on measuring Oral appliance, Continuous positive airway pressure, Obstructive Sleep Apnea Syndrome, Snore
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)
Sites / Locations
- Instituto do Sono/ Associação Fundo de Incentivo a PsicofarmacologiaRecruiting
Outcomes
Primary Outcome Measures
Objective sleep parameters
polysomnographic date of sleep stages percentages, sleep efficience, arousals, apnea-hypopnea index, oxyhemoglobin saturation
Secondary Outcome Measures
Subjective sleep parameters
Sleep disorders questionnaire, the Epworth Sleepiness Scale, and sleep diaries
Quality of life, mood, and anthropometric measurements
SF-36, POMS, neck circumference and craniofacial characteristic
Full Information
NCT ID
NCT01336556
First Posted
April 14, 2011
Last Updated
October 25, 2011
Sponsor
Associacao Fundo de Incentivo a Psicofarmcologia
1. Study Identification
Unique Protocol Identification Number
NCT01336556
Brief Title
Titration of Continuous Positive Airway Pressure Could Predict Success of Oral Appliance to Treat Sleep Apnea
Official Title
Optimal Titration of Continuous Positive Airway Pressure Could Predict Success of Oral Appliance to Treat Obstructive Sleep Apnea Syndrome
Study Type
Interventional
2. Study Status
Record Verification Date
October 2011
Overall Recruitment Status
Unknown status
Study Start Date
October 2010 (undefined)
Primary Completion Date
November 2011 (Anticipated)
Study Completion Date
undefined (undefined)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Associacao Fundo de Incentivo a Psicofarmcologia
4. Oversight
Data Monitoring Committee
Yes
5. Study Description
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.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Obstructive Sleep Apnea
Keywords
Oral appliance, Continuous positive airway pressure, Obstructive Sleep Apnea Syndrome, Snore
7. Study Design
Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
Investigator
Enrollment
60 (Anticipated)
8. Arms, Groups, and Interventions
Intervention Type
Procedure
Intervention Name(s)
Oral appliance
Intervention Description
Anterior mandibular repositioner: used for two months
Primary Outcome Measure Information:
Title
Objective sleep parameters
Description
polysomnographic date of sleep stages percentages, sleep efficience, arousals, apnea-hypopnea index, oxyhemoglobin saturation
Time Frame
two months after the baseline recording
Secondary Outcome Measure Information:
Title
Subjective sleep parameters
Description
Sleep disorders questionnaire, the Epworth Sleepiness Scale, and sleep diaries
Time Frame
two months after the baseline recording
Title
Quality of life, mood, and anthropometric measurements
Description
SF-36, POMS, neck circumference and craniofacial characteristic
Time Frame
two months after the baseline recording
10. Eligibility
Sex
Male
Minimum Age & Unit of Time
25 Years
Maximum Age & Unit of Time
65 Years
Accepts Healthy Volunteers
No
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)
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
Thays CA Cunha
Phone
551121490155
Email
thayscrosara@gmail.com
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Lia Rita A Bittencourt, MD, PhD
Organizational Affiliation
Federal University of São Paulo
Official's Role
Principal Investigator
Facility Information:
Facility Name
Instituto do Sono/ Associação Fundo de Incentivo a Psicofarmacologia
City
São Paulo
State/Province
SP
ZIP/Postal Code
04023-062
Country
Brazil
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Lia Rita A Bittencourt, MD,PhD
Phone
115521490155
Email
lia@psicobio.epm.br
First Name & Middle Initial & Last Name & Degree
Lia Rita A Bittencourt, MD, PhD
Phone
115521490155
Email
lia@psicobio.epm.br
First Name & Middle Initial & Last Name & Degree
Lia Rita A Bittencourt, MD, PhD
First Name & Middle Initial & Last Name & Degree
Thays CA Cunha
12. IPD Sharing Statement
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Titration of Continuous Positive Airway Pressure Could Predict Success of Oral Appliance to Treat Sleep Apnea
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