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

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

PHASE4

Total Enrollment

100 participants

Study Classification

INTERVENTIONAL

Study Start Date

2012-02-29

Study Completion Date

2015-11-30

Brief Summary

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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.

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Detailed Description

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Conditions

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Obstructive Sleep Apnea Syndrome

Study Design

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Allocation Method

NA

Intervention Model

SINGLE_GROUP

Primary Study Purpose

TREATMENT

Blinding Strategy

NONE

Study Groups

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Mandibular Advancement Device (MAD)

Group Type OTHER

Mandibular Advancement Device ( MAD)

Intervention Type DEVICE

Interventions

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Mandibular Advancement Device ( MAD)

Intervention Type DEVICE

Eligibility Criteria

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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

Minimum Eligible Age

18 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No