Status:
UNKNOWN
Upper-airway Changes After Bimaxillary Advancement in OSAHS
Lead Sponsor:
Hospital de Cruces
Collaborating Sponsors:
University of the Basque Country (UPV/EHU)
Biocruces Bizkaia Health Research Institute
Conditions:
OSAHS
Craniofacial Abnormalities
Eligibility:
All Genders
18+ years
Brief Summary
One of the most effective surgical treatments for obstructive sleep apnoea / hypopnoea syndrome (SAHS) with global impact on the upper-airway (UA) is the maxilla-mandibular advancement (MMA). Retrospe...
Detailed Description
HYPOTHESIS: H0: Upper-airway (UA) morphology does not change as a consequence of maxilla-mandibular advancement (MMA) in patients with moderate-severe obstructive sleep apnoea / hypopnoea syndrome (S...
Eligibility Criteria
Inclusion
- ≥18 years-old.
- Diagnosis by polysomnography of moderate-severe obstructive sleep apnoea / hypopnoea syndrome (SAHS) in supine position.
- Approval of the surgical indication by the multidisciplinary sleep committee of our hospital
- Written informed consent (IC) of photography or image recording, orthognathic surgery program inclusion and facial deformity surgery.
- Specific IC for inclusion in the present study.
Exclusion
- Pregnant woman
- Central SAHS
- Medical-surgical history that significantly alter the normal upper-airway anatomy: trauma, tumour, major congenital craniofacial deformity
- Different orthognathic surgery than MMA
- Inconclusive / incomplete tests and data.
Key Trial Info
Start Date :
February 4 2019
Trial Type :
OBSERVATIONAL
Allocation :
ACTUAL
End Date :
November 30 2021
Estimated Enrollment :
38 Patients enrolled
Trial Details
Trial ID
NCT04301635
Start Date
February 4 2019
End Date
November 30 2021
Last Update
February 10 2021
Active Locations (1)
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1
Carlos Prol
Barakaldo, Bizkaia, Spain, 48903