NCT00636181已完成不适用
Positive Airway Pressure Initiation: Impact of Therapy Mode and Titration Process on Adherence and Outcomes
适应症
干预措施
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 168
- 试验地点
- 10
- 主要终点
- Apnea-Hypopnea Index
研究概览
简要总结
Six month at home positive pressure therapy study; which mode of therapy will lead to better adherence and patient outcomes?
详细描述
Three arm randomized controlled trial evaluating therapy titration methodologies and device comfort.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Treatment
- 盲法
- Double (Participant, Investigator)
入排标准
- 年龄范围
- 21 Years 至 75 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 是
入选标准
- •Age 21 - 75
- •Diagnosis of OSAHS with baseline AHI (Apnea-Hypopnea Index) equal or greater than 15 events/hr of sleep
- •Able and willing to provide written informed consent
- •Agreement to try PAP (positive airway pressure) as initial treatment approach
- •Adequate clinical CPAP titration within two weeks of enrollment
排除标准
- •Participation in another interventional research study within the last 30 days
- •The need for more than one titration PSG (polysomnography)
- •The use of sedatives or hypnotics during the titration PSG
- •Major medical or psychiatric condition that would interfere with the demands of the study, adherence to PAP or the ability to commit to follow-up assessment.
- •Prior prescription for, or exposure to PAP therapy within the previous year (except exposure to CPAP during clinical therapy titration.)
- •Chronic respiratory failure or insufficiency with suspected or known neuromuscular disease, moderate or severe COPD (chronic obstructive pulmonary disease) or other pulmonary disorders, or any condition with an elevation of arterial carbon dioxide levels (>45 mmHG) while awake or participants qualifying for oxygen therapy (arterial saturation < or equal to 88% for more than five minutes).
- •Surgery of the upper airway, nose, sinus, or middle ear within the previous 90 days
- •Surgery at any time for the treatment of OSAHS such as uvulopalatopharyngoplasty (UPPP)
- •Presence of untreated or poorly managed, non-OSAHS related sleep disorders:
- •moderate to severe periodic limb movements (greater or equal to 15 per hour with symptoms or arousals)
- •Restless Leg syndrome (greater than 10 per hour)
- •Males experiencing chronic insomnia
- •Use of medications with hypnotic or sedative effects or regular use of night time sedatives or sleeping aids greater than or equal to one night per week.
- •Consumption of ethanol more than 4 nights per week (CAGE criteria)
- •Shift workers
研究组 & 干预措施
Auto Aflex
Active Comparator
auto adjusting positive pressure therapy with AFLEX
干预措施: Auto AFlex (Device)
Auto CPAP
Active Comparator
auto adjusting positive pressure therapy
干预措施: Auto CPAP (Device)
CPAP
Active Comparator
continuous positive airway pressure
干预措施: CPAP (Device)
结局指标
主要结局
Apnea-Hypopnea Index
时间窗: Baseline and 180 Days
The Apnea-Hyopnea Index is the number of average number of apneas (complete pauses in breathing lasting at least 10 seconds) and hypopneas (decreases in airflow lasting at least 10 seconds) per hour of sleep. This data was compared from the polysomnography (sleep study) data after the first night of device use and at 180 days
次要结局
- Average Hours of Nightly Use.(180 days)
- Psychomotor Vigilance Task - Number of Lapses(Baseline and 180 Days)
- Functional Outcomes of Sleep Questionnaire (FOSQ)(Baseline and 180 Days)
- Attitudes Toward Use(Baseline and 180 Days)
- Subjective Assessment of Therapy Comfort.(30, 90, and 180 days)
- Epworth Sleepiness Scale(Baseline and 180 days)
研究者
Clete Kushida
Professor
Stanford University
研究点 (10)
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