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Evaluation of Prefabricated Adjustable Thermoplastic Mandibular Advancement Devices for Obstructive Sleep Apnoea

NCT04124978 · Status: COMPLETED · Phase: NA · Type: INTERVENTIONAL · Enrollment: 32

Last updated 2019-10-16

No results posted yet for this study

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 Asian setting. There are few studies which look at the use of prefabricated thermoplastic mandibular devices with a titratable component and its efficacy. In addition, it is direct-to-consumer and an economical option, thus there may be a role in the use of such devices to better select patients who may benefit and are thinking of using MADs.

The investigators aim to evaluate the effectiveness of the use of Prefabricated adjustable thermoplastic mandibular advancement devices(PAT-MADs)(MyTAP) in the treatment of OSA and its role for predicting treatment success in an Asian population.

Conditions

Interventions

DEVICE

mandibular advancement device

use of prefabricated adjustable mandibular advancement device to improve OSA

Sponsors & Collaborators

  • Singapore General Hospital

    lead OTHER

Principal Investigators

  • Toh Song Tar, MBBS · Singapore General Hospital

Study Design

Allocation
NA
Purpose
TREATMENT
Masking
NONE
Model
SINGLE_GROUP

Eligibility

Min Age
18 Years
Sex
ALL
Healthy Volunteers
Yes

Timeline & Regulatory

Start
2017-07-21
Primary Completion
2019-01-23
Completion
2019-04-23
FDA Device
Yes

Countries

  • Singapore

Study Locations

More Related Trials

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 NCT04124978 on ClinicalTrials.gov