Therapy of Oral Appliance for Adults Jordanians With Obstructive Sleep Apnea

NCT05087316 | Completed DMC

• 1 other identifier: 314/2017
• Study Type: interventional
• Target: 17
• Locations: 1 country
• Sites: 1

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

Outcome Measures

Primary Outcomes (1)

• AHI

  12 weeks

Study Arms (2)

Standard treatment

ACTIVE COMPARATOR

Device: Standard hospital treatment

Oral Appliance

EXPERIMENTAL

Device: biomimetic oral appliance therapy (BOAT)

Interventions

biomimetic oral appliance therapy (BOAT) 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

Oral Appliance

Standard hospital treatment DEVICE

Use of CPAP and similar methods

Standard treatment

Eligibility Criteria

• Age: 18 Years - 80 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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.

You may not qualify if:

• Patients who are unable to attend regular appointments and unable to consent.

Sponsors & Collaborators

• Jordan University of Science and Technology: lead

Study Sites (1)

King abdullah University Hospital (KAUH)

Irbid, Others, 22110, Jordan

Location

Related Publications (1)

• 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.

  PMID: 39465752 DERIVED

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: SUPPORTIVE CARE
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: September 22, 2021
• First Posted: October 21, 2021
• Study Start: March 1, 2017
• Primary Completion: March 1, 2019
• Study Completion: March 1, 2019
• Last Updated: October 21, 2021

Record last verified: 2021-10

Data Sharing

• IPD Sharing: Will not share

Locations

JO (1)