Evaluation of the three-dimensional airway with a Conebeam CT(CBCT) scan to evaluate the upper-airway's in patientis with different degrees of severity of OSAS.
ID
Source
Brief title
Condition
- Upper respiratory tract disorders (excl infections)
Synonym
Research involving
Sponsors and support
Intervention
Outcome measures
Primary outcome
3-D CT, total airway volume (mm3) and configuration of the oropharyngeal area,
minimal cross-sectional area and the localization of the minimal
cross-sectional area.
Secondary outcome
Patients treated with an MRD (Mandibular Repositioning Device) will be scanned
twice, with and withouth wearing the MRD. The primary study parameters with and
withouth MRD will be compared.
Background summary
The central research question: Is there an correlation between airway changes
in volume and shape in patients with different degrees of severity of OSAS,
Obstructive Sleep Apnea Syndrome?
OSAS is caused by an obstruction of the upper airway. The correlation between
different degrees of severity of OSAS and the changes in the oropharyngeal area
are not fully understood. The purpose of this study is to give a clearer image
of the severity of obstruction of the oropharyngeal area and severity of OSAS.
Study objective
Evaluation of the three-dimensional airway with a Conebeam CT(CBCT) scan to
evaluate the upper-airway's in patientis with different degrees of severity of
OSAS.
Study design
A prospective series of 30 patients with OSAS will be studied with 3D-airway
CBCT.
Study burden and risks
Patients will undergo one or two CBCT scan's of the oropharyngeal area during
one visit. The number of scans depend on the use of an MRD. One CB-CT scan will
take 40 seconds and has no direct risks uposed upon the patient. A CBCT-scan is
non-invasive and the extent of the burden for the patient will therefore be
small. The advantage of the CBCT scan is the radiation tax, this tax is much
higher in conventional CT-scanning. Long term risks depending on radiation tax
are smaller.
postbus 9101
6500 HB Nijmegen
Nederland
postbus 9101
6500 HB Nijmegen
Nederland
Listed location countries
Age
Inclusion criteria
clinical symptoms(>2); snoring, daytime somnolence and apnea with witness.
apnea-hypopneaindex(AHI) >5/hour
Exclusion criteria
clinical symptoms(<2); snoring, daytime somnolence and apnea with witness
apnea-hypopneaindex(AHI)<5/hour
patients with nasal, oral, pharyngeal or mandibular abnormalities or diseases.
patients with previous surgery in the pharynxregion
patients treated with CPAP, ten tijde van onderzoek.
Design
Recruitment
Medical products/devices used
Followed up by the following (possibly more current) registration
No registrations found.
Other (possibly less up-to-date) registrations in this register
No registrations found.
In other registers
| Register | ID |
|---|---|
| CCMO | NL26388.091.08 |