Therapy of Oral Appliance for Adults Jordanians With Obstructive Sleep Apnea (TOAAJOSA)

Jordan University of Science and Technology

Status

Completed

Conditions

Mild Obstructive Sleep Apnea

Treatments

Device: biomimetic oral appliance therapy (BOAT)

Device: Standard hospital treatment

Study type

Interventional

Funder types

Other

Identifiers

NCT05087316

314/2017

Details and patient eligibility

About

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.

Enrollment

17 patients

Sex

All

Ages

18 to 80 years old

Volunteers

No Healthy Volunteers

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