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Therapy of Oral Appliance for Adults Jordanians With Obstructive Sleep Apnea

Not Applicable
Completed
Conditions
Mild Obstructive Sleep Apnea
Registration Number
NCT05087316
Lead Sponsor
Jordan University of Science and Technology
Brief Summary

Introduction: Obstructive Sleep Apnea (OSA) is the most common form of sleep disordered breathing. Patients who arrive at the dental office with a diagnosis of OSA are often treated with a mandibular advancement device (MAD). A biomimetic oral appliance therapy (BOAT), offers an alternative non-surgical method, which can putatively resolve OSA by combined maxilla-mandibular correction, and addressing craniofacial deficiencies.

The aim: To determine whether maxilla-mandibular correction changes induced by BOAT produce a more favorable upper airway, which might result in a reduction in the severity of OSA.

Protocol: Adults who underwent an overnight sleep study and were diagnosed by a sleep specialist physician will be potential subjects for the current study. The BQ and EES will be recorded pre- and post- BOAT treatment. Subjects with mild to moderate OSA will have 2 months follow up visits and a final overnight sleep study to measure apnea-hypopnea index (AHI). The subjects will be asked to wear the appliance for 10-12 hours/day and at night. Findings will be analyzed statistically using paired t-tests.

Detailed Description

Not available

Recruitment & Eligibility

Status
COMPLETED
Sex
All
Target Recruitment
17
Inclusion Criteria
  • Confirmed diagnosis of mild to moderate OSA with good oral hygiene
  • Intolerant to CPAP therapy
  • Having enough number of maxillary and mandibular teeth to retain the removable device.
Exclusion Criteria
  • Patients who are unable to attend regular appointments and unable to consent.
  • Patients with severe OSA who met the inclusion criteria

Study & Design

Study Type
INTERVENTIONAL
Study Design
PARALLEL
Primary Outcome Measures
NameTimeMethod
AHI12 weeks
Secondary Outcome Measures
NameTimeMethod

Trial Locations

Locations (1)

King abdullah University Hospital (KAUH)

🇯🇴

Irbid, Others, Jordan

King abdullah University Hospital (KAUH)
🇯🇴Irbid, Others, Jordan

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