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Titration of Oral Appliance Therapy: a Prospective, Randomized Cross-over Trial.

NCT03716648 · Status: COMPLETED · Phase: NA · Type: INTERVENTIONAL · Enrollment: 10

Last updated 2021-07-30

No results posted yet for this study

Summary

In this prospective randomized cross-over trial, 3 different titration procedures will be compared:

1. titration of the mandibular advancement device (MAD) in the home setting based on both the physical limits of the patient's mandibular protrusion and the resolution of subjective complaints, as currently often used in routine clinical practice;
2. an overnight titration PSG using the remotely controlled mandibular positioner (RCMP) with stepwise mandibular protrusion until respiratory events are reduced and
3. incremental protrusion of the mandible during DISE using the RCMP until upper airway collapse at all collapsible levels is eliminated.

The aim of this study is to prospectively compare the target protrusion, as well as the treatment outcome in terms of treatment efficacy, of the 3 different titration protocols.

Conditions

Interventions

DIAGNOSTIC_TEST

DISE-assisted titration

Titration of the mandibular position with the remotely controlled mandibular positioner during drug-induced sleep endoscopy.

DIAGNOSTIC_TEST

PSG-guided titration

Titration of the mandibular position with the remotely controlled mandibular positioner during drug-induced sleep endoscopy.

DEVICE

subjective titration

Titration of the mandibular position based on subjective improvement in symptoms like snoring and excessive daytime sleepiness.

Sponsors & Collaborators

  • University Hospital, Antwerp

    lead OTHER

Principal Investigators

  • Olivier Vanderveken, MD, PhD · University Hospital, Antwerp

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
NONE
Model
CROSSOVER

Eligibility

Min Age
18 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2019-05-22
Primary Completion
2021-04-07
Completion
2021-04-07

Countries

  • Belgium

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 NCT03716648 on ClinicalTrials.gov