PROMAD: Predicting Therapeutic Outcome of Mandibular Advancement Device Treatment in Obstructive Sleep Apnea
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| First Received Date ICMJE | January 30, 2012 | ||||||||
| Last Updated Date | February 8, 2012 | ||||||||
| Start Date ICMJE | Not Provided | ||||||||
| Primary Completion Date | Not Provided | ||||||||
| Current Primary Outcome Measures ICMJE | Not Provided | ||||||||
| Original Primary Outcome Measures ICMJE | Not Provided | ||||||||
| Change History | Complete list of historical versions of study NCT01532050 on ClinicalTrials.gov Archive Site | ||||||||
| Current Secondary Outcome Measures ICMJE | Not Provided | ||||||||
| Original Secondary Outcome Measures ICMJE | Not Provided | ||||||||
| Current Other Outcome Measures ICMJE | Not Provided | ||||||||
| Original Other Outcome Measures ICMJE | Not Provided | ||||||||
| Descriptive Information | |||||||||
| Brief Title ICMJE | PROMAD: Predicting Therapeutic Outcome of Mandibular Advancement Device Treatment in Obstructive Sleep Apnea | ||||||||
| Official Title ICMJE | PROMAD : Predicting Therapeutic Outcome of Mandibular Advancement Device Treatment in Obstructive Sleep Apnea | ||||||||
| 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. |
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| Detailed Description | Not Provided | ||||||||
| Study Type ICMJE | Interventional | ||||||||
| Study Phase | Phase 4 | ||||||||
| Study Design ICMJE | Intervention Model: Single Group Assignment | ||||||||
| Condition ICMJE | Obstructive Sleep Apnea Syndrome | ||||||||
| Intervention ICMJE | Device: Mandibular Advancement Device ( MAD) | ||||||||
| Study Arm (s) | Mandibular Advancement Device (MAD)
Intervention: Device: Mandibular Advancement Device ( MAD) |
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| Publications * | Not Provided | ||||||||
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* Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline. |
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| Recruitment Information | |||||||||
| Recruitment Status ICMJE | Recruiting | ||||||||
| Enrollment ICMJE | Not Provided | ||||||||
| Completion Date | Not Provided | ||||||||
| Primary Completion Date | Not Provided | ||||||||
| Eligibility Criteria ICMJE | Inclusion Criteria:
Exclusion Criteria:
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| Gender | Both | ||||||||
| Ages | 18 Years and older | ||||||||
| Accepts Healthy Volunteers | Not Provided | ||||||||
| Contacts ICMJE |
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| Location Countries ICMJE | Belgium | ||||||||
| Administrative Information | |||||||||
| NCT Number ICMJE | NCT01532050 | ||||||||
| Other Study ID Numbers ICMJE | IWT MRA UZA | ||||||||
| Has Data Monitoring Committee | No | ||||||||
| Responsible Party | Ethisch Comité UZ Antwerpen, University Hospital, Antwerp | ||||||||
| Study Sponsor ICMJE | Ethisch Comité UZ Antwerpen | ||||||||
| Collaborators ICMJE | Not Provided | ||||||||
| Investigators ICMJE | Not Provided | ||||||||
| Information Provided By | University Hospital, Antwerp | ||||||||
| Verification Date | February 2012 | ||||||||
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ICMJE Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP |
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