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Therapy of Oral Appliance for Adults Jordanians With Obstructive Sleep Apnea

NCT05087316 · Status: COMPLETED · Phase: NA · Type: INTERVENTIONAL · Enrollment: 17

Last updated 2021-10-21

No results posted yet for this study

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

Interventions

DEVICE

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

DEVICE

Standard hospital treatment

Use of CPAP and similar methods

Sponsors & Collaborators

  • Jordan University of Science and Technology

    lead OTHER

Study Design

Allocation
RANDOMIZED
Purpose
SUPPORTIVE_CARE
Masking
NONE
Model
PARALLEL

Eligibility

Min Age
18 Years
Max Age
80 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2017-03-01
Primary Completion
2019-03-01
Completion
2019-03-01

Countries

  • Jordan

Study Locations

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Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT05087316 on ClinicalTrials.gov