Portable Monitoring and APAP Treatment for Diagnosis and Treatment of OSA
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 156
- 试验地点
- 2
- 主要终点
- Positive Airway Pressure Adherence (Nightly Use of Treatment)
研究概览
简要总结
The purpose of this randomized prospective study is to compare the efficacy of two approaches to initiate Positive Airway Pressure (PAP) treatment in patients diagnosed as having obstructive sleep apnea (OSA) by portable monitoring (PM) (limited sleep study). One pathway involves attended Continuous Positive Airway Pressure (CPAP) titration by PSG (full attended sleep study) followed by CPAP treatment. The other pathway involves treatment with auto-adjusting positive airway pressure (APAP)(without a titration). Study Aims: Compare PAP adherence, improvement in subjective sleepiness (Epworth Sleepiness Scale), reaction time (Psychomotor vigilance test), quality of life by the Functional Outcomes of Sleep Questionnaire (FOSQ), and PAP satisfaction (PAP satisfaction questionnaire) between the two study arms.
详细描述
RESEARCH PLAN: All patients being evaluated for possible OSA are required to attend a Sleep Education and Evaluation Class before having a sleep study. At this class they receive information on sleep apnea, PAP treatment, and the types of sleep studies. They also complete a sleep questionnaire to identify co-existing sleep disorders and important co-morbid medical conditions. Screening of the sleep questionnaire and the patient's medical record is part of routine care to identify patients needing a diagnostic PSG and/or an attended titration. At the end of the class, participation in the current study will be offered the patients. Those signifying interest in being part of the research study and meeting inclusion and exclusion criteria will be contacted to participate in the study. Once they sign an informed consent they will be randomized to one of the two clinical pathways.
METHODS: Study visits:
Before informed consent (routine clinical care)
- Sleep Education and Evaluation Class (education about OSA, sleep studies, and OSA treatment). Patients complete screening sleep and medical history questionnaires.
- Determination of patient interest in participating in the current study and review of inclusion/exclusion criteria
After informed consent
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
- None
入排标准
- 年龄范围
- 21 Years 至 89 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •OSA, Apnea-hypopnea index > 5/hour
排除标准
- •Prior CPAP
- •Uncontrolled Depression
- •Moderate to Severe chronic obstructive pulmonary disease (COPD)
- •Hypoventilation
- •Average estimated nightly total sleep time < 4 hours
- •Shift work
- •Unstable depression
- •Upper airway surgery
- •Uncontrolled Restless legs syndrome (RLS), narcolepsy
- •Use of supplemental oxygen
- •Severe congestive heart failure
- •Use of nightly potent narcotics
- •Severe obesity (BMI > 40)
结局指标
主要结局
Positive Airway Pressure Adherence (Nightly Use of Treatment)
时间窗: 6 weeks after starting treatment
average nightly hours of using positive airway pressure (including 0 for nights not used)
次要结局
- Change in Epworth Sleepiness Scale(6 weeks after starting treatment)
- Change in Functional Outcomes of Sleep Questionnaire(6 weeks at clinic)
- Residual Apnea-hypopnea Index(over first 6 weeks of treatment)
- Treatment Pressure (Level of CPAP or 90th Percentile APAP)(6 weeks clinic)
研究者
Richard Berry
Professor of Medicine University of Florida
North Florida Foundation for Research and Education