Nasal and Oronasal Mask During CPAP Titration on CPAP Level, Apnoea-hypopnoea Index, Airway Defense Biomarkers and Systemic Expression of mi RNA in Patients With Severe Obstructive Sleep Apnea and no History of Nasal Obstruction
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 25
- 试验地点
- 4
- 主要终点
- Changes in Apnea-Hypopnea Index
研究概览
简要总结
The obstructive sleep apnea (OSA) affects between 10% to 25% of the adults. Continuous positive airway pressure (CPAP) is the first choice of treatment in severe OSA. However, the adherence to CPAP varies, and the interface between patient and the CPAP may interfere with adherence, comfort and efficiency as well as in sleep variables. Objectives: (1) to determine if self-reported airflow route (nasal or oronasal airflow) is the same as the route determined in a laboratory analysis in controls (healthy subjects) and severe OSA patients with nasal free airflow of obstruction during asleep and awake, (2) to compare the effects of nasal and oronasal CPAP titration (randomized order of masks, 14 days apart) on apnoea-hypopnoea index, CPAP level, PSG variables - including analysis for body positioning, the airway defense mechanisms (nasal mucociliary clearance, mucus properties, citology and inflammation in nasal lavage fluid) and systemic effects (serum miRNA expression and cytokines), (3) CPAP adherence after 1 month and 12 months.
详细描述
After agreement with the written informed consent, 30 volunteers (10 healthy volunteers and 20 patients with severe OSA), male and female, aged > 21 years were recruited in the Sleep Laboratory of Hospital das Clínicas da Faculdade de Medicina (FMUSP). The volunteers were evaluated at the Sleep Laboratory (Incor) in two phases. First Phase: volunteers were assessed for breathing route awake and asleep (including respiratory events in OSA patients) and were indicated as nasal breathing and oronasal breathing. Second phase for OSA patients: two manual full-night CPAP titration with nasal and oronasal masks in a randomized order, 14 days apart. Data and fluids were analyzed before and after both titration studies comparing both masks including supine and lateral position during asleep and CPAP titration. Third phase for OSA patiens: patients were treated with the best interface found in CPAP titration study during 30 days and patients were assessed for sleep quality, excessive sonolence during the day, airway symptoms, airway defense mechanisms biomarkers (mucociliary clearance, mucus properties, citology, inflammation cytokines and adhesion molecules and others) and serum cytokines and miRNA.
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 (Outcomes Assessor)
入排标准
- 年龄范围
- 21 Years 至 80 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 是
入选标准
- •>21 years
- •moderate or severe obstructive sleep apnea
- •nonsmokers
- •ex smokers (cessation >12 months)
排除标准
- •infection / acute respiratory inflammation (30 days after to study entry)
- •history of fixed nasal obstruction
- •nasal or upper airways surgery
- •chronic diseases without optimized treatment
结局指标
主要结局
Changes in Apnea-Hypopnea Index
时间窗: Baseline (Time 0), after CPAP titration with nasal and oronasal mask (one night with wash out of two weeks) and after 30-day period of treatment
A full-night diagnostic polysomnography (PSG) was performed in each subject to determine the stages of sleep, an electroencephalogram, electro-oculogram and electromyogram of the submentalis muscle were obtained. Peripheric blood oxygenation was recorded with the use of a finger pulse oximeter. Thoracoabdominal excursions were measured qualitatively using respiratory effort sensors placed over the ribcage and abdomen. Snoring was detected with a vibration snore sensor and body posture with a body position sensor. Subjects used a molded single-piece translucent silicone rubber mask. During titration, a mask with CPAP was added and the procedure was performed according to AASM guidelines.
次要结局
- Airway inflammation by exhaled breath condensate pH(Participants will be assessed at baseline (Time 0), nasal CPAP, oronasal CPAP and after 30-day CPAP treatment (30 days))
- Sleep quality by Pittsburg Questionnaire(Participants will be assessed at at baseline (Time 0) and after CPAP treatment (30 days))
- Upper airways symptoms by SNOT20 questionnaire(Participants will be assessed at at baseline (Time 0) and CPAP treatment (30 days))
- Excessive sonolence during daytime by Epworth Sleepiness Scale(Participants will be assessed at at baseline (Time 0) and CPAP treatment (30 days))
- Nasal mucociliary clearance by saccharine transit time(Participants were assessed at at baseline (Time 0), nasal CPAP, oronasal CPAP and after 30-day CPAP treatment (30 days))
- Nasal inflammation by pH, citology and cytokines and adhesion molecules in nasal lavage(Participants were assessed at baseline (Time 0) and after nasal titration, oronasal titration and CPAP treatment (30 days))
研究者
Naomi Kondo Nakagawa
Associate Professor of Physiotherapy
University of Sao Paulo