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

NCT03716648 | Completed

• 1 other identifier: 18/33/364
• Study Type: interventional
• Target: 10
• Locations: 1 country
• Sites: 1

Brief Summary

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

1. 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. 2.an overnight titration PSG using the remotely controlled mandibular positioner (RCMP) with stepwise mandibular protrusion until respiratory events are reduced and
3. 3.incremental protrusion of the mandible during DISE using the RCMP until upper airway collapse at all collapsible levels is eliminated.

Conditions

Obstructive Sleep Apnea

Outcome Measures

Primary Outcomes (1)

• The amount of protrusion (mm)

  The protrusive position that was predicted as the effective target protrusive position during each titration method (subjective titration, RCMP titration PSG and RCMP titration DISE) will be assessed and compared between the different titration methods.

  After the patient underwent the three titration procedures, so approximately 4 months after start of the study

Secondary Outcomes (1)

• The apnea/hypopnea index (AHI) derived from the polysomnographic evaluation.

  After the patient underwent the three titration procedures, so approximately 4 months after start of the study

Other Outcomes (3)

• Visual analogue scale for snoring

  After the patient underwent the three titration procedures, so approximately 4 months after start of the study

• Epworth sleepiness scale

  After the patient underwent the three titration procedures, so approximately 4 months after start of the study

• Checklist Individual Strenght

  After the patient underwent the three titration procedures, so approximately 4 months after start of the study

Study Arms (3)

Subjective titration

ACTIVE COMPARATOR

After fitting the MAD, there is a 1-month period during which the patients get used to wearing the device and titrate the MAD based on improvement of subjective complaints. The actual mechanism of titration will be individually trained with each patient.

Device: subjective titration

DISE-assisted titration

EXPERIMENTAL

Incremental protrusion of the mandible during drug-induced sleep endoscopy using the remotely controlled mandibular positioner until upper airway collapse at all collapsible levels is eliminated.

Diagnostic Test: DISE-assisted titration

PSG-guided titration

EXPERIMENTAL

An overnight titration polysomnograph using the remotely controlled mandibular positioner with stepwise mandibular protrusion until respiratory events are reduced.

Diagnostic Test: PSG-guided titration

Interventions

DISE-assisted titration DIAGNOSTIC_TEST

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

DISE-assisted titration

PSG-guided titration DIAGNOSTIC_TEST

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

PSG-guided titration

subjective titration DEVICE

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

Subjective titration

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Patients with moderate to severe obstructive sleep apnea (OSA) (obstructive AHI (oAHI) ≥ 15/h)
• BMI \< 30 kg/m²
• Age \> 18 year
• PSG \< 2 years old with stable body weight (+/- 5 kg), no ENT surgery since most recent PSG and stable clinical condition
• Normal clinical and radiological (incl. OPG), periodontal en temporomandibular joint examination
• Subject is capable of giving informed consent
• No documented abuses (alcohol, drugs, …)

You may not qualify if:

• Edentulous patients
• Insufficient teeth to support the mandibular advancement device
• Active periodontal problems including tooth mobility
• Active temporomandibular joint dysfunction
• Limited maximum protrusive capacity (\<6 mm)
• Limited vertical opening (\<25 mm)
• Enlarged palatine tonsils (Grade IV tonsils)
• Degenerative neuromuscular disorders
• Pregnancy or willing to become pregnant

Sponsors & Collaborators

• University Hospital, Antwerp: lead

Study Sites (1)

University of Antwerp

Antwerp, Belgium

Location

Related Publications (1)

• Dieltjens M, Braem MJ, Op de Beeck S, Vroegop AVMT, Kazemeini E, Van de Perck E, Beyers J, Kastoer C, Wouters K, Willemen M, Verbraecken JA, Vanderveken OM. Remotely controlled mandibular positioning of oral appliance therapy during polysomnography and drug-induced sleep endoscopy compared with conventional subjective titration in patients with obstructive sleep apnea: protocol for a randomized crossover trial. Trials. 2019 Oct 29;20(1):615. doi: 10.1186/s13063-019-3698-4.

  PMID: 31665059 DERIVED

MeSH Terms

Conditions

Sleep Apnea, Obstructive

Condition Hierarchy (Ancestors)

Sleep Apnea Syndromes; Apnea; Respiration Disorders; Respiratory Tract Diseases; Sleep Disorders, Intrinsic; Dyssomnias; Sleep Wake Disorders; Nervous System Diseases

Study Officials

• Olivier Vanderveken, MD, PhD

  University Hospital, Antwerp

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: CROSSOVER
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: prof. dr. Olivier Vanderveken, MD, PhD

Model Details: Randomized, crossover study

Study Record Dates

• First Submitted: October 9, 2018
• First Posted: October 23, 2018
• Study Start: May 22, 2019
• Primary Completion: April 7, 2021
• Study Completion: April 7, 2021
• Last Updated: July 30, 2021

Record last verified: 2021-07

Data Sharing

• IPD Sharing: Will not share

Locations

BE (1)