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

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

Status
Completed
Phases
Phase 4
Study type
Interventional
Source
ClinicalTrials.gov
Registry ID
NCT01532050
Acronym
PROMAD
Enrollment
100
Registered
2012-02-13
Start date
2012-02-29
Completion date
2015-11-30
Last updated
2021-01-20

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Obstructive Sleep Apnea Syndrome

Keywords

OSAS, American Academy of Sleep Medicine Task Force

Brief summary

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.

Interventions

DEVICEMandibular Advancement Device ( MAD)

Sponsors

ethisch.comite@uza.be
Lead SponsorOTHER

Study design

Allocation
NA
Intervention model
SINGLE_GROUP
Primary purpose
TREATMENT
Masking
NONE

Eligibility

Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
No

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

Design outcomes

Primary

MeasureTime frameDescription
Predictive value of DISE and CFD3 monthsPositive and negative predictive values for AHI based treatment outcome

Countries

Belgium

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Mar 4, 2026