Treatment of obstructive sleep apnea in the elderly with intraoral appliance
Phase 1
Recruiting
- Conditions
- Sleep Apnea, Obstructive
- Registration Number
- RBR-44y22nj
- Lead Sponsor
- FAPERGS - Fundação de Amparo à Pesquisa do Estado do Rio Grande do Sul
- Brief Summary
Not available
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- Recruiting
- Sex
- Not specified
- Target Recruitment
- Not specified
Inclusion Criteria
Healthy volunteers; both genders; aged 65 years or older.
Exclusion Criteria
Volunteer with less than 8 teeth in the lower jaw; dental implants installed less than 6 months ago; mouth breathers; mouth opening less than 30mm; temporomandibular joint pain or dysfunction; facial anomalies or neoplasms; absence of sleep apnea or severe apnea (score 30 or more); diagnoses of cardiac, hepatic, pulmonary, neurological or psychiatric pathologies.
Study & Design
- Study Type
- Intervention
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method Decrease in the apnea and hypopnea index to at least 10, measured by respiratory polygraphy after 60 days of use of the intraoral device.
- Secondary Outcome Measures
Name Time Method Aumento de pelo menos 10% do volume da via aérea superior, medido em tomografia computadorizada de feixe cônico obtida após 60 dias de uso do aparelho intraoral, em comparação ao exame inicial.