Status:
COMPLETED
Continuous Positive Airway Pressure and Oral Appliances Treatments in Mild Obstructive Sleep Apnea
Lead Sponsor:
Associação Fundo de Incentivo à Pesquisa
Conditions:
Mild Obstructive Sleep Apnea Syndrome
Eligibility:
All Genders
18-65 years
Phase:
NA
Brief Summary
Treatment response of mild obstructive sleep apnea (OSA) to continuous positive airway pressure (CPAP) therapy and oral appliance (OA) is still controversial. The aim of this study is to evaluate the ...
Eligibility Criteria
Inclusion
- Both genders;
- body mass index lower than 35Kg/m2;
- age between 18 and 65 years old;
- polysomnographic and clinical diagnosis of mild apnea (apnea-hypopnea index of 5 or more events per hour of sleep and less than 15 and minimum mandibular protrusion of 7mm.
Exclusion
- Unsatisfactory dental conditions (active periodontal disease, extensive caries or insufficient teeth for appliance content);
- temporomandibular disorders (chronic joint or muscle disease); central apnea; claustrophobia and severe otorhinolaryngologic diseases (severe nasal septal deviation, marked hypertrophy of nasal turbinates, hypertrophy of tonsils and/or adenoids sharp);
- excessive use of alcohol and psychoactive drugs;
- clinical, neurological or psychiatric decompensated diseases;
- others sleep diseases and previous obstructive sleep apnea treatment.
Key Trial Info
Start Date :
October 1 2011
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
November 1 2019
Estimated Enrollment :
79 Patients enrolled
Trial Details
Trial ID
NCT01461486
Start Date
October 1 2011
End Date
November 1 2019
Last Update
November 13 2019
Active Locations (1)
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1
Associação Fundo de Incentivo à Pesquisa
São Paulo, São Paulo, Brazil, 04024-002