Therapy of Oral Appliance for Adults Jordanians With Obstructive Sleep Apnea

NCT ID: NCT05087316

Last Updated: 2021-10-21

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: NA
• Total Enrollment: 17 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2017-03-01
• Study Completion Date: 2019-03-01

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.

Conditions

Mild Obstructive Sleep Apnea

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: SUPPORTIVE_CARE
• Blinding Strategy: NONE

Study Groups

Standard treatment

Group Type: ACTIVE_COMPARATOR

Standard hospital treatment

Intervention Type: DEVICE

Use of CPAP and similar methods

Oral Appliance

Group Type: EXPERIMENTAL

biomimetic oral appliance therapy (BOAT)

Intervention Type: DEVICE

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

Interventions

biomimetic 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

Intervention Type: DEVICE

Standard hospital treatment

Use of CPAP and similar methods

Intervention Type: DEVICE

Eligibility Criteria

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.

• Minimum Eligible Age: 18 Years
• Maximum Eligible Age: 80 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Jordan University of Science and Technology

OTHER

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Locations

King abdullah University Hospital (KAUH)

Irbid, Others, Jordan

Countries

Jordan

References

Khasawneh L, Al Mortadi N, Abu-Ishqair E, Khassawneh B, Alzoubi KH. Cone beam computed tomography changes upon oral appliance therapy for adult patients with obstructive sleep apnea: A non-randomized clinical trial. Medicine (Baltimore). 2024 Oct 4;103(40):e39923. doi: 10.1097/MD.0000000000039923.

Reference Type: DERIVED

PMID: 39465752 (View on PubMed)

Other Identifiers

314/2017

Identifier Type: -

Identifier Source: org_study_id