Treatment of Sleep Apnea with Innovative Intraoral Appliance Customized by Digital Flow

Not Applicable

Recruiting

• Conditions: Sleep Apnea, Obstructive; Continuous Positive Airway Pressure; Mandibular Advancement; G47.3

• Registration Number: RBR-3m46ncg
• Lead Sponsor: niversidade de Brasília - Faculdade de Ciências da Saúde

Brief Summary

Not available

Detailed Description

Not available

Study Timeline

• Results First Posted: 1900-01-01
• Study Start: 2024-03-21
• Last Update Posted: 2 April 2024
• Study Completion: 2025-10-10

Recruitment & Eligibility

• Status: Recruiting
• Sex: Not specified
• Target Recruitment: Not specified

Inclusion Criteria

The inclusion criteria in the treatment group are individuals diagnosed with mild apnea (apnea-hipopnea index bigger than five and smaller than fifteen), moderate apnea (apnea-hipopnea index bigger than fifteen and smaller than thirty) and severe apnea (apnea-hipopnea index bigger than thirty and smaller than fifty) by type I polysomnography; individuals who used Continuous Positive Airway Pressure and did not adapt or just want an alternative to this type of treatment; individuals who refused surgical treatment; individuals with age between forty and seventy years of both genres; individuals with at least ten teeth per arch, including crowns on implants or complete dentures over implants

Exclusion Criteria

The exclusion criterias of the treatment group are patients who are edentulous or do not have a minimum amount of teeth per arch necessary for the retention and stability of the intraoral appliance during treatment; patients with severe periodontal disease; patients with acute temporomandibular disorder; patients with pathological evidence of airway obstruction; pacientes with Body Mass Index (BMI = weight/height2) greater than thirty five

Study & Design

• Study Type: Intervention
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
Evaluate the effectiveness of the mandibular advancement device in reducing the oxygen desaturation rate and snoring.

Secondary Outcome Measures

Name	Time	Method
o secondary outcomes are expected.