Therapy of Oral Appliance for Adults Jordanians With Obstructive Sleep Apnea (TOAAJOSA)
Primary Purpose
Mild Obstructive Sleep Apnea
Status
Completed
Phase
Not Applicable
Locations
Jordan
Study Type
Interventional
Intervention
biomimetic oral appliance therapy (BOAT)
Standard hospital treatment
Sponsored by
About this trial
This is an interventional supportive care trial for Mild Obstructive Sleep Apnea
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.
- Patients with severe OSA who met the inclusion criteria
Sites / Locations
- King abdullah University Hospital (KAUH)
Arms of the Study
Arm 1
Arm 2
Arm Type
Active Comparator
Experimental
Arm Label
Standard treatment
Oral Appliance
Arm Description
Outcomes
Primary Outcome Measures
AHI
Secondary Outcome Measures
Full Information
NCT ID
NCT05087316
First Posted
September 22, 2021
Last Updated
October 8, 2021
Sponsor
Jordan University of Science and Technology
1. Study Identification
Unique Protocol Identification Number
NCT05087316
Brief Title
Therapy of Oral Appliance for Adults Jordanians With Obstructive Sleep Apnea
Acronym
TOAAJOSA
Official Title
Biometric Oral Appliance Therapy for the Treatment of Obstructive Sleep Apnea in Adults
Study Type
Interventional
2. Study Status
Record Verification Date
October 2021
Overall Recruitment Status
Completed
Study Start Date
March 1, 2017 (Actual)
Primary Completion Date
March 1, 2019 (Actual)
Study Completion Date
March 1, 2019 (Actual)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Jordan University of Science and Technology
4. Oversight
Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
Yes
5. Study Description
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.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Mild Obstructive Sleep Apnea
7. Study Design
Primary Purpose
Supportive Care
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
None (Open Label)
Allocation
Randomized
Enrollment
17 (Actual)
8. Arms, Groups, and Interventions
Arm Title
Standard treatment
Arm Type
Active Comparator
Arm Title
Oral Appliance
Arm Type
Experimental
Intervention Type
Device
Intervention Name(s)
biomimetic oral appliance therapy (BOAT)
Intervention Description
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
Intervention Name(s)
Standard hospital treatment
Intervention Description
Use of CPAP and similar methods
Primary Outcome Measure Information:
Title
AHI
Time Frame
12 weeks
10. Eligibility
Sex
All
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
80 Years
Accepts Healthy Volunteers
No
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.
Patients with severe OSA who met the inclusion criteria
Facility Information:
Facility Name
King abdullah University Hospital (KAUH)
City
Irbid
State/Province
Others
ZIP/Postal Code
22110
Country
Jordan
12. IPD Sharing Statement
Plan to Share IPD
No
Learn more about this trial
Therapy of Oral Appliance for Adults Jordanians With Obstructive Sleep Apnea
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