Clinial Study of Treatment With Mandibular Advancement Device in Patients With Obstructive Sleep Apnea Across 6 General Hospitals

NCT06837285 | Completed

• 1 other identifier: EVO_AZ-Sites_2025
• Study Type: observational
• Target: 182
• Locations: 1 country
• Sites: 6

Brief Summary

Study Objectives: To retrospectively study mandibular advancement treatment efficacy using apnea-hypopnea index (AHI) and oxygen desaturation index (ODI), in a large cohort of patients, in 'real world' settings across 6 general hospitals. Methods: Diagnosis at 6 Belgian recognised OSA sleepcenters with type-1 polysomnography. After drug-induced sleep endoscopy by Ear-Nose-Troat-specialist, patients with positive effect of mandibular protrusion on reopening the upper airway were referred. The mandibular advancement device (MAD) was fitted in 'maximal comfortable protrusion' minus 2mm. A type-3 home polygraphy with MAD followed titration.

Conditions

Obstructive Sleep Apnea (OSA); Mandibular Advancement Device

Keywords

obstructive sleep apnea; non invasive therapy; mandibular advancement device

Outcome Measures

Primary Outcomes (6)

• Respiratory index "apnea-hypopnea index" (AHI)

  The first primary outcome is an expected improvement in apnea-hypopnea index (AHI; number of apneas and hypopneas per hour of sleep; a higher AHI means more severe obstructive sleep apnea) upon MAD treatment (MADt). Functional objective outcome measure is the quantification of the effect of MADt on AHI. "Success" is defined as treatment AHI≤15 events/h following the Belgian threshold for reimbursement, and any decrease in baseline AHI.

  From enrollment to the control home polygraphy at 3 to 5 months after fitting the MAD

• Respiratory index "oxygen desaturation index" (ODI)

  The second primary outcome is an expected improvement in respiratory parameter oxygen desaturation index (ODI; number of desaturations per hour of sleep; a higher ODI means a more severe condition) upon MAD treatment (MADt). Functional objective outcome measure is the quantification of the effect of MADt on ODI. "Success" is defined as treatment AHI≤15 events/h following the Belgian threshold for reimbursement, and any decrease in baseline AHI.

  From enrollment to the control home polygraphy at 3 to 5 months after fitting the MAD

• Obstructive sleep apnea severity

  The third primary outcome is an expected improvement in OSA severity category upon MAD treatment (MADt). Categories are defined as AHI 5-14.9/hour = mild OSA; AHI 15-29.9/hour = moderate OSA; and OSA ≥30/hour = severe OSA.

  From enrollment to the control home polygraphy at 3 to 5 months after fitting the MAD

• Visual analogue score for snoring

  The fourth primary outcome is an expected improvement in snoring as reported by the patient. This functional subjective outcome measure quantifies the snoring using a questionnaire with a visual analogue score on loudness of snoring (VAS-snore) with a Likert-scale from 0 (no snoring) up to 10 (partner sleeps in other room). A VAS-snore \> 3/10 represents socially disturbing snoring. The higher the VAS-snore score the louder the snoring is.

  From enrollment to the control home polygraphy at 3 to 5 months after fitting the MAD

• Epworth Sleepiness Scale

  The fifth primary outcome is an expected improvement in daytime sleepiness as reported by the patient. This functional subjective outcome measure quantifies the propensity to fall asleep during daytime activities, using a questionnaire with with the Epworth Sleepiness Score-scale (ESS) from 0 (no propensity to fall asleep) up to 24 (extremely high propensity to fall asleep). An EES-score ≥ 11/24 represents a pathological increased daytime sleepiness. The higher the ESS-score the more pronounce the daytime sleepiness is.

  From enrollment to the control home polygraphy at 3 to 5 months after fitting the MAD

• Titration

  The sixth primary outcome is the amount of titration required at the moment when the control home-polygraphy (HPG) is recorded. The starting position of the MADt was set at the maximal comfortable protrusion (MCP) minus 2mm: first the mandibular maximal protrusive trajectory was measured in millimeters. Next, MCP was determined, being the most forward mandibular protrusion still tolerated by the patient. The actual protrusive position of the MAD at the time of the HPG minus the start position quantifies the amount of protrusion. This result cannot be interpreted in terms of a 'higher' protrusion as a 'better' protrusion since this is a patient specific characteristic, as is the range of mandibular protrusion.

  From enrollment to the control home polygraphy at 3 to 5 months after fitting the MAD

Interventions

mandibular advancement device DEVICE

Results of clinical trials on MADs are regularly published in the international literature but are generally very strongly controlled studies, still far away from being applied in routine daily clinical practice. The current retrospective study evaluates real-world data to determine the extent to which MAD improves both symptoms in patients with OSA. It is estimated that about 3% of newly diagnosed OSA patients are treated with MAD. In the light of new future treatment conventions, health government departments are increasingly demanding real-world data to stimulate knowledge of the relative effectiveness and value of treatments in the management of patients in routine clinical settings.

Eligibility Criteria

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

Study Population

patients referred by sleep physicians and after ear-nos-troat-specialist examination, for mandibular advancement treatment in routine clinical settings.

You may qualify if:

• obstructive apnea-hypopnea index ≥ 15 events/h sleep
• complete clinical pathway

You may not qualify if:

• obstructive apnea-hypopnea index \< 15 events/h sleep
• not dental fit

Sponsors & Collaborators

• University Hospital, Antwerp: lead
• AZ Sint-Maarten: collaborator
• AZ Voorkempen: collaborator
• AZ Monica Campus Antwerpen: collaborator
• Imelda Hospital, Bonheiden: collaborator
• Vitaz: collaborator
• Heilig Hart Ziekenhuis Lier: collaborator

Study Sites (6)

AZ Voorkempen

Malle, Antwerpen, 2390, Belgium

Location

Imelda Ziekenhuis Bonheiden

Bonheiden, Mechelen, 2820, Belgium

Location

VITAZ

Sint-Niklaas, Oost-Vlaanderen, 9100, Belgium

Location

AZ Monica

Antwerp, 2000, Belgium

Location

Heilig Hartziekenhuis Lier

Lier, 2500, Belgium

Location

AZ Sint-Maarten

Mechelen, 2800, Belgium

Location

MeSH Terms

Conditions

Sleep Apnea, Obstructive

Interventions

Occlusal Splints

Condition Hierarchy (Ancestors)

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

Intervention Hierarchy (Ancestors)

Orthotic Devices; Orthopedic Equipment; Surgical Equipment; Equipment and Supplies

Study Officials

• Marc J BRAEM, DDS, PhD

  UZA Afd. Tandheelkunde

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: RETROSPECTIVE
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: em. prof. dr.

Study Record Dates

• First Submitted: February 10, 2025
• First Posted: February 20, 2025
• Study Start: September 22, 2021
• Primary Completion: October 24, 2024
• Study Completion: October 24, 2024
• Last Updated: February 24, 2025

Record last verified: 2025-02

Data Sharing

• IPD Sharing: Will not share

Locations

BE (6)