Upper-airway Changes After Bimaxillary Advancement in Moderate-severe Obstructive Sleep Apnoea / Hypopnoea Syndrome
试验速览
- 阶段
- 不适用
- 发起方
- 入组人数
- 38
- 试验地点
- 1
- 主要终点
- Upper-airway morphology: Vertical length
研究概览
简要总结
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.
详细描述
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 (SAHS).
H1: UA changes as a consequence of MMA in patients with moderate-severe SAHS. To answer this hypothesis, the following will be determined: Vertical UA length, volume, axial areas, ellipticity, uniformity, prevertebral soft tissue (PST) and soft palate (SP) lengths and position of the hyoid bone.
As secondary hypotheses:
H0: Clinical outcomes of MMA in moderate-severe SAHS are not successful. H1: Clinical outcomes of MMA in moderate-severe SAHS are successful. To answer, the apnoea / hypopnoea index (AHI), pulse oximeter oxygen saturation (SPO2) and daytime sleepiness will be determined.
研究设计
- 研究类型
- Observational
- 观察模型
- Cohort
- 时间视角
- Other
入排标准
- 年龄范围
- 18 Years 至 —（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •≥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.
排除标准
- •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.
结局指标
主要结局
Upper-airway morphology: Vertical length
时间窗: Through study completion, an average of 1 year
From computed-tomography examinations. Total, retropalatal compartment, retro-glossal compartment, hypopharynx compartment and summatory. Measured in mm.
Upper-airway morphology: area
时间窗: Through study completion, an average of 1 year
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.
Upper-airway morphology: ellipticity
时间窗: Through study completion, an average of 1 year
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.
Upper-airway morphology: uniformity
时间窗: Through study completion, an average of 1 year
A formula: minimum area / (hard palate area + uvula tip area + epiglottis tip area + hyoid bone area) Measured in units from 0 to 1.
Upper-airway morphology: position of the hyoid bone
时间窗: Through study completion, an average of 1 year
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.
Upper-airway morphology: volume
时间窗: Through study completion, an average of 1 year
From computed-tomography examinations. Total, retropalatal compartment, retro-glossal compartment, hypopharynx compartment and summatory. Measured in mm\^3.
Upper-airway morphology: prevertebral soft tissue length
时间窗: Through study completion, an average of 1 year
From computed-tomography examinations. Measured in mm.
Upper-airway morphology: soft palate length
时间窗: Through study completion, an average of 1 year
From computed-tomography examinations. Measured in mm.
次要结局
- Dental-cranium-facial morphology: non-validated facial aesthetics test: general satisfaction(Through study completion, an average of 1 year)
- Dental-cranium-facial morphology: non-validated facial aesthetics test: face slimness(Through study completion, an average of 1 year)
- Clinical outcomes: Apnoea / hypopnoea index(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 convexity(Through study completion, an average of 1 year)
- Dental-cranium-facial morphology: Ricketts cephalometric basic analysis: labial protrusion(Through study completion, an average of 1 year)
- Dental-cranium-facial morphology: non-validated facial aesthetics test: modifications perceived by the patient(Through study completion, an average of 1 year)
- Dental-cranium-facial morphology: non-validated facial aesthetics test: modifications perceived by family members and friends(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 depth(Through study completion, an average of 1 year)
- Dental-cranium-facial morphology: Ricketts cephalometric basic analysis: mandibular plane angle(Through study completion, an average of 1 year)
- Dental-cranium-facial morphology: Ricketts cephalometric basic analysis: lower facial height(Through study completion, an average of 1 year)
- Dental-cranium-facial morphology: Ricketts cephalometric basic analysis: incisor inclination(Through study completion, an average of 1 year)
- Dental-cranium-facial morphology: Ricketts cephalometric basic analysis: interincisal angle(Through study completion, an average of 1 year)
- Dental-cranium-facial morphology: non-validated facial aesthetics test: face rejuvenation(Through study completion, an average of 1 year)
- Dental-cranium-facial morphology: Ricketts cephalometric basic analysis: maxillary depth(Through study completion, an average of 1 year)
- Dental-cranium-facial morphology: Ricketts cephalometric basic analysis: incisor protrusion(Through study completion, an average of 1 year)
- Dental-cranium-facial morphology: Ricketts cephalometric basic analysis: incisor extrusion(Through study completion, an average of 1 year)
- Dental-cranium-facial morphology: Ricketts cephalometric basic analysis: upper molar position(Through study completion, an average of 1 year)
- Dental-cranium-facial morphology: Ricketts cephalometric basic analysis: mandibular arch(Through study completion, an average of 1 year)
- Dental-cranium-facial morphology: non-validated facial aesthetics test: smile(Through study completion, an average of 1 year)
研究者
Carlos Prol Teijeiro
Oral & Maxillofacial Consultant
Hospital de Cruces