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Upper-airway Changes After Bimaxillary Advancement in OSAHS

NCT04301635 · Status: UNKNOWN · Type: OBSERVATIONAL · Enrollment: 38

Last updated 2021-02-10

No results posted yet for this study

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). Retrospective-prospective observational study of: clinical outcomes, UA and dental-cranium-facial (DCF) morphology.

Population sample will be patients treated in the Maxillofacial Surgery department of "Hospital de Cruces". As inclusion criteria: ≥18 years-old, moderate-severe SAHS in supine position, multidisciplinary committee of sleep pathology evaluation for surgical indication, and written informed consents. As exclusion criteria: pregnant woman, SAHS of central origin, cranium-facial deformities that significantly modify normal UA, different surgery than MMA and inconclusive / incomplete tests. It is estimated ≥90% males; ≥90% 30-59 years-old; ≤10% extreme weights; 25% complementary surgeries; and sample size 40. Medical ethics code of the Declaration of Helsinki will be taken into account. To collect the pre- / postoperative data we will use, calibrated and standardized: polysomnography (PSG), computed tomography (CT), right face profile picture (RFP) and lateral teleradiography of the cranium (LTC). Furthermore, the Epworth scale and non-validated subjective self-perception test of facial aesthetics will be performed.

Clinical outcomes will be evaluated from PSG using apnoea / hypopnoea index and pulse oximeter oxygen saturation, and from Epworth scale. UA morphology from CT, globally and by specific locations, through lengths, volumes, areas, dimensions, and other measurements. DCF aspects from RFP and LTC, by Ricketts cephalometric basic analysis and facial aesthetics test. Statistical, descriptive analysis of frequencies and comparative by pairs of quantitative data will be by t-Student or Wilcoxon test, after checking the variables normality with the Kolmogorov-Smirnov test.

Conditions

  • OSAHS
  • Craniofacial Abnormalities

Interventions

PROCEDURE

Maxillo-mandibular Advancement + Counterclockwise rotation

Maxilla: Lefort I osteotomy Mandible: Obwegeser-Dal-Pont osteotomy Movements: Advance and counterclockwise rotation

Sponsors & Collaborators

  • University of the Basque Country (UPV/EHU)

    collaborator OTHER

  • Biocruces Bizkaia Health Research Institute

    collaborator OTHER_GOV

  • Hospital de Cruces

    lead OTHER

Principal Investigators

  • Carlos Prol, Mr · Osakidetza

Eligibility

Min Age
18 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2019-02-04
Primary Completion
2019-12-31
Completion
2021-11-30

Countries

  • Spain

Study Locations

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Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT04301635 on ClinicalTrials.gov