Status:
UNKNOWN
Effects of Two Different Amounts of Mandibular Protrusion in OSA Patients Using Mandibular Advancement Appliance
Lead Sponsor:
University of Malaya
Conditions:
Obstructive Sleep Apnea
Eligibility:
All Genders
18+ years
Phase:
NA
Brief Summary
Obstructive sleep apnea (OSA) is a complex disease associated with repeated closure of the upper airway during sleep which causes excessive daytime sleepiness. Daytime sleepiness can affects daytime p...
Detailed Description
This is a single-center, double blind (patients and sleep analyst) prospective randomized controlled trial to be conducted at Faculty of Dentistry, University of Malaya. Eligible and consented patien...
Eligibility Criteria
Inclusion
- Mild and moderate OSA patients who are keen on MAA
- Severe OSA who had refuse CPAP
- Aged 18 years and older
- Without any form of prior treatment
- Absence of any structural obstruction examined by otolaryngologist
- Sufficient set of teeth to hold the appliance
Exclusion
- Presence of periodontal disease
- Exaggerated gag reflex and temporomandibular joint disorder
- Significant co-morbidity that could endanger the patient's health
- Any psychiatric or neurological diseases previously known that could impair the compliance
- Any medication intake that can influence sleep
- Co-existing sleep disorders other than OSA for instance insomnia, central sleep apnea and etc
- Pregnant candidates
Key Trial Info
Start Date :
August 1 2019
Trial Type :
INTERVENTIONAL
Allocation :
ESTIMATED
End Date :
May 31 2022
Estimated Enrollment :
20 Patients enrolled
Trial Details
Trial ID
NCT04079153
Start Date
August 1 2019
End Date
May 31 2022
Last Update
September 29 2020
Active Locations (1)
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1
Faculty of Dentistry, University of Malaya
Petaling Jaya, Kuala Lumpur, Malaysia, 50603