Mandibular Advancement Device (MAD) and Continuous Positive Airway Pressure (CPAP) for Treatment of Obstructive Sleep Apnea
试验速览
- 阶段
- 不适用
- 状态
- 尚未招募
- 入组人数
- 70
- 试验地点
- 1
- 主要终点
- Objective treatment effect of MAD and CPAP treatment for treatment of moderate OSA assessed by Apnea-Hypopnea Index (AHI)
研究概览
简要总结
Obstructive sleep apnea (OSA) is a frequent illness related to sleep and breathing with many symptoms and complications. The primary choices of treatment are continuous positive airway pressure (CPAP) and removable appliance for protruding the mandible when sleeping (MAD). Treatment with CPAP is superior to treatment with MAD but many patients don't tolerate CPAP why they seek treatment with MAD. In Denmark, treatment with MAD is not free of charge unlike treatment with CPAP and MAD is therefore not offered systematically to the patients. The same applies to adjustment, control and effect of the MAD treatment. MAD treatment has a positive effect on OSA in general but the effect varies due to differences in selection of patients and lack of specifying who performs and evaluates MAD treatment, the effect on sleep and possible side effects in muscles and the temporomandibular joint as well as the occlusion during treatment. It is therefore of great importance to investigate the effect of MAD treatment as well as short- and long-term side effects. The aim is therefore to compare the treatment effect of MAD and CPAP and how significant the investigation of the airways and the face is for the treatment effect and possible side effects. The project is a 4-year investigation and 70 adult patients diagnosed with moderate OSA are included. The results from the investigation will be of great importance for the choice of treatment and prognosis for the individual patient and socio-economic since the treatment of OSA could be tailored the individual patient and the treatment effect optimised.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Crossover
- 主要目的
- Treatment
- 盲法
- Single (Investigator)
盲法说明
Investigator blinded to the DISE
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
- •* Objectively diagnosed with moderate OSA (AHI 15-29)
- •* \>/= 18 years
- •* BMI \/= 20 teeth.
- •* Evenly distributed occlusal contacts
排除标准
- •Known craniofacial anomalies
- •General inflammatory joint diseases
- •Maximal protrusion of the mandible < 6 mm
- •Severe deep bite
- •Anterior open bite
- •Severe attrition
- •Severe bruxism and involuntary mandibular movements
- •Conditions demanding treatment such as temporomandibular disorders (TMD)
- •Chronically pronounced nasal stenosis
- •Hypertrophic tonsils (tonsil size 3-4)
- •Prior blood clot in the brain or in the heart
- •Heart arrythmias
- •Other severe systemic diseases
- •Epilepsia
- •Allergies towards peanuts, soy or egg
- •Consumption of morphine or other sedatives which cannot be paused
- •Pregnant or breast-feeding women
结局指标
主要结局
Objective treatment effect of MAD and CPAP treatment for treatment of moderate OSA assessed by Apnea-Hypopnea Index (AHI)
时间窗: From enrollment to the end of treatment at 24 months
Defined as the number of apneas and hypopneas per hour of sleep, with higher values indicating greater severity
Objective treatment effect of MAD and CPAP treatment for treatment of moderate OSA assessed by Oxygen Desaturation Index (ODI)
时间窗: From enrollment to the end of treatment at 24 months
Defined as the number of oxygen desaturation events per hour of sleep, with higher values indicating more severe nocturnal hypoxemia
Objective treatment effect of MAD and CPAP treatment for treatment of moderate OSA assessed by acoustic pharyngo- and rhinometry
时间窗: From enrollment to the end of treatment at 24 months
Measured as volume, mean area, minimum cross-sectional area (MCA), distance to MCA and calculated resistance
Subjective treatment effect of MAD and CPAP treatment for treatment of moderate OSA assessed by Epworth Sleepiness Scale (ESS)
时间窗: From enrollment to the end of treatment at 24 months
Scale 0-24, higher scores indicate greater daytime sleepiness
Subjective treatment effect of MAD and CPAP treatment for treatment of moderate OSA assessed by Pittsburgh Sleep Quality Index (PSQI)
时间窗: From enrollment to the end of treatment at 24 months
Scale 0-21, higher scores indicate worse sleep quality
Subjective treatment effect of MAD and CPAP treatment for treatment of moderate OSA assessed by Berlin Questionnaire (BQ)
时间窗: From enrollment to the end of treatment at 24 months
The Berlin Questionnaire classifies individuals as high or low risk for obstructive sleep apnea based on three symptom categories; high risk is defined as having two or more positive categories
Subjective treatment effect of MAD and CPAP treatment for treatment of moderate OSA assessed by Short Form 36 (SF-36)
时间窗: From enrollment to the end of treatment at 24 months
The SF-36 assesses health-related quality of life across eight domains, each scored from 0 to 100, with higher scores indicating better health status
次要结局
- The significance of DISE and craniofacial morphology for the objective and subjective treatment effect of MAD and CPAP assessed by lateral cephalogram(At baseline and at the end of treatment at 24 months)
- The significance of DISE and craniofacial morphology for the objective and subjective treatment effect of MAD and CPAP assessed by cone-beam CT (CBCT)(At baseline and at the end of treatment at 24 months)
- The significance of DISE and craniofacial morphology for the objective and subjective treatment effect of MAD and CPAP assessed by VOTE-classification(DISE is performed before treatment)
- The significance of DISE and craniofacial morphology for any short- and long-term predictions on side-effects in dental occlusion and oro-facial function during MAD-treatment assessed by VOTE-classification(DISE is performed before treatment.)
- The significance of DISE and craniofacial morphology for any short- and long-term predictions on side-effects in dental occlusion and oro-facial function during MAD-treatment assessed by lateral cephalogram(At baseline and at the end of treatment at 24 months)
- The significance of DISE and craniofacial morphology for any short- and long-term predictions on side-effects in dental occlusion and oro-facial function during MAD-treatment assessed by cone-beam CT (CBCT)(At baseline and at the end of treatment at 24 months)
- The significance of DISE and craniofacial morphology for any short- and long-term predictions on side-effects in dental occlusion and oro-facial function during MAD-treatment assessed by Diagnostic Criteria for Temporomandibular Disorders (DC/TMD)(From enrollment to the end of treatment at 24 months)
- The significance of DISE and craniofacial morphology for any short- and long-term predictions on side-effects in dental occlusion and oro-facial function during MAD-treatment assessed by dental occlusion(From enrollment to the end of treatment at 24 months)
- The significance of DISE and craniofacial morphology for any short- and long-term predictions on side-effects in dental occlusion and oro-facial function during MAD-treatment assessed by bite-force(From enrollment to the end of treatment at 24 months)
- The significance of DISE and craniofacial morphology for any short- and long-term predictions on side-effects in dental occlusion and oro-facial function during MAD-treatment assessed by short-form Oral Health Impact Profile (OHIP-14)(From enrollment to the end of treatment at 24 months)
- The significance of DISE and craniofacial morphology for any short- and long-term predictions on side-effects in dental occlusion and oro-facial function during MAD-treatment assessed by Nordic Oro-facial Test-Screening (NOT-S)(From enrollment to the end of treatment at 24 months)