Therapy of Oral Appliance for Adults Jordanians With Obstructive Sleep Apnea

Biometric Oral Appliance Therapy for the Treatment of Obstructive Sleep Apnea in Adults

Status

Completed

Phases

Study type

Interventional

Source

ClinicalTrials.gov

Registry ID

NCT05087316

Acronym

TOAAJOSA

Enrollment

Registered

2021-10-21

Start date

2017-03-01

Completion date

2019-03-01

Last updated

2021-10-21

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Mild Obstructive Sleep Apnea

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.

Interventions

DEVICEbiomimetic oral appliance therapy (BOAT)

BOAT appliance is designed to correct maxillo-mandibular underdevelopment in both children and adults (Singh and Lipka, 2009). However, adults will only use for this study. Typically, a BOAT appliance consists of 6 patented, anterior 3-D Axial Springs™, a midline actuator (such as omega loops or screws), posterior occlusal rests, and a round labial bow (Figure 1). Patients will be trained on activation of the screw

DEVICEStandard hospital treatment

Use of CPAP and similar methods

Study design

Allocation

RANDOMIZED

Intervention model

PARALLEL

Primary purpose

SUPPORTIVE_CARE

Masking

NONE

Eligibility

Sex/Gender

ALL

Age

18 Years to 80 Years

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

* Patients who are unable to attend regular appointments and unable to consent. * Patients with severe OSA who met the inclusion criteria

Design outcomes

Primary

Measure	Time frame
AHI	12 weeks

Countries

Jordan

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026