Therapy of Oral Appliance for Adults Jordanians With Obstructive Sleep Apnea

Not Applicable

Completed

• Conditions: Mild Obstructive Sleep Apnea
• Interventions: Device: Standard hospital treatment; Device: biomimetic oral appliance therapy (BOAT)

• 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

Study Timeline

• Study Start: 2017-03-01
• Primary Completion: 2019-03-01
• Study Completion: 2019-03-01
• Study First Submitted: 2021-09-22
• Status Verified: 2021-10
• Study First Submitted QC: 2021-10-08
• Last Update Submitted: 2021-10-08
• Study First Posted: 2021-10-21
• Last Update Posted: 2021-10-21

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

Arm && Interventions

Group	Intervention	Description
Standard treatment	Standard hospital treatment	-
Oral Appliance	biomimetic oral appliance therapy (BOAT)	-

Primary Outcome Measures

Name	Time	Method
AHI	12 weeks

Trial Locations

Locations (1)

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