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

Obstructive Sleep Apnea Syndrome Clinical Trial

— PROMAD  

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT01532050
• Other study ID #: IWT MRA UZA
• Status: Completed
• Phase: Phase 4
• Start date: February 2012
• Est. completion date: November 2015

Study information

• Verified date: January 2021
• Source: University Hospital, Antwerp
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 100
• Est. completion date: November 2015
• Est. primary completion date: July 2015
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

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

Related Conditions & MeSH terms

• Apnea
• Obstructive Sleep Apnea Syndrome
• Sleep Apnea Syndromes
• Sleep Apnea, Obstructive

Intervention

Device:
• Mandibular Advancement Device ( MAD)

Locations

Country	Name	City	State
Belgium	Antwerp University Hospital	Edegem	Antwerp

Sponsors (1)

Lead Sponsor	Collaborator
ethisch.comite@uza.be

Country where clinical trial is conducted

Belgium, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Predictive value of DISE and CFD	Positive and negative predictive values for AHI based treatment outcome	3 months