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OpenTrials
Completed

NCT Number: NCT05087316

Therapy of Oral Appliance for Adults Jordanians With Obstructive Sleep Apnea

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.

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Key information

Conditions

Mild Obstructive Sleep Apnea

Age range

18 year–80 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

King abdullah University Hospital (KAUH)

Irbid, Others, 22110, Jordan

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

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

Standard hospital treatment

Device

Use of CPAP and similar methods

Primary outcomes

  1. AHI

    Time frame: 12 weeks

Sponsors and collaborators

Lead sponsor

Jordan University of Science and Technology

Other

Registry information

Official study title

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

Acronym: TOAAJOSA

Important dates

Study start
2017
Primary completion
2019
Study completion
2019
First posted
Oct 21, 2021
Registry last updated
Oct 21, 2021

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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