PROMAD: Predicting Therapeutic Outcome of Mandibular Advancement Device Treatment in Obstructive Sleep Apnea (PROMAD)

PROMAD : Predicting Therapeutic Outcome of Mandibular Advancement Device Treatment in Obstructive Sleep Apnea

The present research intends to focus clinically on selecting the right type of patient for mandibular advancement devices (MAD) therapy using screening tools such as advanced imaging and computational methods based on CT-Scan images as well as drug-induced sleep nasendoscopy techniques with simulation of the mandibular repositioning. The core of the research project relies on known and established methods accepted in several neighboring fields, but aims at the transfer of this knowledge by integrating it into this new domain. Doing so, the proposed biomedical research is directed towards clinical applications that incorporate innovative developments on the level of the diagnosis and therapy of a specific disease, being obstructive sleep apnea syndrome (OSAS). Furthermore, this study aims at registering objective compliance during MAD therapy.

Study Overview

• Status: Completed
• Conditions: Obstructive Sleep Apnea Syndrome
• Intervention / Treatment: Device: Mandibular Advancement Device ( MAD)

• Study Type: Interventional
• Enrollment (Actual): 100
• Phase: Phase 4

Contacts and Locations

Study Locations

• Belgium
  • Antwerp
    • Edegem, Antwerp, Belgium, 2650
      • Antwerp University Hospital

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years and older (Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

Inclusion Criteria:

• Age ≥ 18 years
• body mass index (BMI) ≤ 35 kg/m²
• OSAS, as defined by the American Academy of Sleep Medicine Task Force
• apnea-hypopnea index (AHI) < 50

Exclusion Criteria:

• Other sleep disorders (i.e. parasomnias)
• Invasive upper airway surgery for sleep-disordered breathing
• Known genetic disorders with craniofacial and/or upper airway malformations
• Use of benzodiazepine and/or antidepressants
• Known history of psychiatric disease
• Known history of fibromyalgia and/or chronic fatigue syndrome
• Dental contra-indications: functional restrictions of the temporomandibular joint, insufficient dentition with pathological changes, insufficient retention for MAD use

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: N/A
• Interventional Model: Single Group Assignment
• Masking: None (Open Label)

Number of Arms

1

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Other: Mandibular Advancement Device (MAD)	Device: Mandibular Advancement Device ( MAD)

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Predictive value of DISE and CFD	Positive and negative predictive values for AHI based treatment outcome	3 months

Collaborators and Investigators

• Sponsor: ethisch.comite@uza.be

Publications and helpful links

General Publications

• Van Gaver H, Op de Beeck S, Dieltjens M, De Backer J, Verbraecken J, De Backer WA, Van de Heyning PH, Braem MJ, Vanderveken OM. Functional imaging improves patient selection for mandibular advancement device treatment outcome in sleep-disordered breathing: a prospective study. J Clin Sleep Med. 2022 Mar 1;18(3):739-750. doi: 10.5664/jcsm.9694.
• Op de Beeck S, Dieltjens M, Azarbarzin A, Willemen M, Verbraecken J, Braem MJ, Wellman A, Sands SA, Vanderveken OM. Mandibular Advancement Device Treatment Efficacy Is Associated with Polysomnographic Endotypes. Ann Am Thorac Soc. 2021 Mar;18(3):511-518. doi: 10.1513/AnnalsATS.202003-220OC.
• Van de Perck E, Op de Beeck S, Dieltjens M, Vroegop AV, Verbruggen AE, Willemen M, Verbraecken J, Van de Heyning PH, Braem MJ, Vanderveken OM. The relationship between specific nasopharyngoscopic features and treatment deterioration with mandibular advancement devices: a prospective study. J Clin Sleep Med. 2020 Jul 15;16(7):1189-1198. doi: 10.5664/jcsm.8474.
• Op de Beeck S, Dieltjens M, Verbruggen AE, Vroegop AV, Wouters K, Hamans E, Willemen M, Verbraecken J, De Backer WA, Van de Heyning PH, Braem MJ, Vanderveken OM. Phenotypic Labelling Using Drug-Induced Sleep Endoscopy Improves Patient Selection for Mandibular Advancement Device Outcome: A Prospective Study. J Clin Sleep Med. 2019 Aug 15;15(8):1089-1099. doi: 10.5664/jcsm.7796.
• Dieltjens M, Verbruggen AE, Braem MJ, Wouters K, Verbraecken JA, De Backer WA, Hamans E, Van de Heyning PH, Vanderveken OM. Determinants of Objective Compliance During Oral Appliance Therapy in Patients With Sleep-Disordered Breathing: A Prospective Clinical Trial. JAMA Otolaryngol Head Neck Surg. 2015 Oct;141(10):894-900. doi: 10.1001/jamaoto.2015.1756.

Study record dates

Study Major Dates

• Study Start: February 1, 2012
• Primary Completion (Actual): July 1, 2015
• Study Completion (Actual): November 1, 2015

Study Registration Dates

• First Submitted: January 30, 2012
• First Submitted That Met QC Criteria: February 8, 2012
• First Posted (Estimate): February 13, 2012

Study Record Updates

• Last Update Posted (Actual): January 20, 2021
• Last Update Submitted That Met QC Criteria: January 15, 2021
• Last Verified: January 1, 2021

More Information

Terms related to this study

• Keywords: OSAS; American Academy of Sleep Medicine Task Force
• Additional Relevant MeSH Terms: Nervous System Diseases; Respiratory Tract Diseases; Respiration Disorders; Sleep Disorders, Intrinsic; Dyssomnias; Sleep Wake Disorders; Signs and Symptoms, Respiratory; Sleep Apnea Syndromes; Sleep Apnea, Obstructive; Apnea
• Other Study ID Numbers: IWT MRA UZA