Upper-airway Changes After Bimaxillary Advancement in OSAHS

NCT04301635 | Unknown DMC

• 1 other identifier: SAHS_PROL
• Study Type: observational
• Target: 38
• Locations: 1 country
• Sites: 1

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). 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

Keywords

OSAHS; Sleep disorder; Orthognathic surgery; Maxillomandibular advancement; Counterclockwise rotation

Outcome Measures

Primary Outcomes (8)

• Upper-airway morphology: Vertical length

  From computed-tomography examinations. Total, retropalatal compartment, retro-glossal compartment, hypopharynx compartment and summatory. Measured in mm.

  Through study completion, an average of 1 year

• Upper-airway morphology: volume

  From computed-tomography examinations. Total, retropalatal compartment, retro-glossal compartment, hypopharynx compartment and summatory. Measured in mm\^3.

  Through study completion, an average of 1 year

• Upper-airway morphology: area

  From computed-tomography examinations. Minimum, hard palate plane, parallel uvula tip plane, parallel epiglottis tip plane, parallel inferior edge of the hyoid bone plane. Measured in mm. Measured in mm\^2.

  Through study completion, an average of 1 year

• Upper-airway morphology: ellipticity

  A formula: transversal dimension / anteroposterior dimension. Dimensions characteristics are: From computed-tomography examinations. Minimum, hard palate plane, parallel uvula tip plane, parallel epiglottis tip plane, parallel inferior edge of the hyoid bone plane. Measured in mm.

  Through study completion, an average of 1 year

• Upper-airway morphology: uniformity

  A formula: minimum area / (hard palate area + uvula tip area + epiglottis tip area + hyoid bone area) Measured in units from 0 to 1.

  Through study completion, an average of 1 year

• Upper-airway morphology: prevertebral soft tissue length

  From computed-tomography examinations. Measured in mm.

  Through study completion, an average of 1 year

• Upper-airway morphology: soft palate length

  From computed-tomography examinations. Measured in mm.

  Through study completion, an average of 1 year

• Upper-airway morphology: position of the hyoid bone

  From computed-tomography examinations. Measured in mm in the anteroposterior aspect and also the superoinferior aspect, this one is the same measure as vertical length.

  Through study completion, an average of 1 year

Secondary Outcomes (22)

• Clinical outcomes: Apnoea / hypopnoea index

  Through study completion, an average of 1 year

• Clinical outcomes: pulse oximeter oxygen saturation.

  Through study completion, an average of 1 year

• Clinical outcomes: daytime sleepiness

  Through study completion, an average of 1 year

• Dental-cranium-facial morphology: Ricketts cephalometric basic analysis: facial axis angle

  Through study completion, an average of 1 year

• Dental-cranium-facial morphology: Ricketts cephalometric basic analysis: facial depth

  Through study completion, an average of 1 year

Study Arms (2)

Preoperative (Pre-)

Moderate-severe obstructive sleep apnoea / hypopnoea patients, preoperative

Procedure: Maxillo-mandibular Advancement + Counterclockwise rotation

Postoperative (Post-)

Moderate-severe obstructive sleep apnoea / hypopnoea patients, postoperative

Procedure: Maxillo-mandibular Advancement + Counterclockwise rotation

Interventions

Maxillo-mandibular Advancement + Counterclockwise rotation PROCEDURE

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

Also known as: Bimaxillary Advancement, Orthognathic Surgery

Postoperative (Post-); Preoperative (Pre-)

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)
• Sampling Method: Non-Probability Sample

Study Population

Adult patients treated in a single centre: Maxillofacial Surgery department, "Hospital de Cruces", Barakaldo, Spain Time period from 01/01/2012 to 01/31/2019.

You may qualify if:

• ≥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

You may not qualify if:

• 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.

Sponsors & Collaborators

• Hospital de Cruces: lead
• University of the Basque Country (UPV/EHU): collaborator
• Biobizkaia Health Research Institute: collaborator

Study Sites (1)

Carlos Prol

Barakaldo, Bizkaia, 48903, Spain

Location

MeSH Terms

Conditions

Sleep Apnea, Obstructive; Craniofacial Abnormalities; Sleep Wake Disorders

Interventions

Orthognathic Surgery

Condition Hierarchy (Ancestors)

Sleep Apnea Syndromes; Apnea; Respiration Disorders; Respiratory Tract Diseases; Sleep Disorders, Intrinsic; Dyssomnias; Nervous System Diseases; Musculoskeletal Abnormalities; Musculoskeletal Diseases; Congenital Abnormalities; Congenital, Hereditary, and Neonatal Diseases and Abnormalities; Neurologic Manifestations; Signs and Symptoms; Pathological Conditions, Signs and Symptoms; Mental Disorders

Intervention Hierarchy (Ancestors)

Surgery, Oral; Dentistry

Study Officials

• Carlos Prol, Mr

  Osakidetza

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: OTHER
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Oral & Maxillofacial Consultant

Study Record Dates

• First Submitted: March 4, 2020
• First Posted: March 10, 2020
• Study Start: February 4, 2019
• Primary Completion: December 31, 2019
• Study Completion: November 30, 2021
• Last Updated: February 10, 2021

Record last verified: 2021-02

Locations

ES (1)