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Effects of Two Different Amounts of Mandibular Protrusion in OSA Patients Using Mandibular Advancement Appliance

NCT04079153 · Status: UNKNOWN · Phase: NA · Type: INTERVENTIONAL · Enrollment: 20

Last updated 2020-09-29

No results posted yet for this study

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 performance undesirably and reduces driving performance causing an increased risk for accidents. It can also lead to high blood pressure, strokes, and eventually death.

Until now, there is no standardize value for the jaw advancement for the mandibular advancement appliance. It was found that when comparing the jaw advancement amount of 50% and above 50%, there is no additional efficacy. Efficacy of jaw advancement below 50% is lacking. Patients usually experience more complications with more advancement, there the investigators need to study the optimal mandibular advancement with least complication to the patients.

Conditions

Interventions

DEVICE

Mandibular advancement Appliance

Advances the mandible at desired range at a fixed vertical dimension

Sponsors & Collaborators

  • University of Malaya

    lead OTHER

Principal Investigators

  • Lau May Nak · University of Malaya

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
DOUBLE
Model
PARALLEL

Eligibility

Min Age
18 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2019-08-01
Primary Completion
2022-05-31
Completion
2022-05-31

Countries

  • Malaysia

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Entities

Diseases

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 NCT04079153 on ClinicalTrials.gov