Status:
COMPLETED
Evaluation of Prefabricated Adjustable Thermoplastic Mandibular Advancement Devices for Obstructive Sleep Apnoea
Lead Sponsor:
Singapore General Hospital
Conditions:
Obstructive Sleep Apnea
Eligibility:
All Genders
18+ years
Phase:
NA
Brief Summary
Use of mandibular advancement devices(MADs) in the treatment of Obstructive Sleep Apnea is established, however this is hampered by high costs, long wait times and non-assured success in the local Asi...
Detailed Description
Mandibular advancement devices (MAD) serve as an adjunct to the treatment of snoring as well as mild-moderate OSA. It is widely accepted that upper airway muscle activity decreases during sleep, leadi...
Eligibility Criteria
Inclusion
- 18years old and above
- English competency
- Formal diagnosis of mild-moderate OSA on PSG
- Ability to provide informed consent
Exclusion
- diagnosed severe OSA
- evidence of central sleep apnea events
- dental conditions which preclude proper use of the MAD
- treatment with other devices (e.g. tongue retainers, PAP therapy)
- pregnancy
- known allergic reactions to the components of the study product were excluded from the trial.
Key Trial Info
Start Date :
July 21 2017
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
April 23 2019
Estimated Enrollment :
32 Patients enrolled
Trial Details
Trial ID
NCT04124978
Start Date
July 21 2017
End Date
April 23 2019
Last Update
October 16 2019
Active Locations (1)
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1
Singapore General Hospital
Singapore, Singapore, 169608