Comparison of Two Techniques of Combination Therapy for Treatment of Obstructive Sleep Apnea (OSA)
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 发起方
- 入组人数
- 28
- 试验地点
- 2
- 主要终点
- Intolerance Questionnaire
研究概览
简要总结
To study the effects of two combination therapies for patients with obstructive sleep apnea (OSA) who have been both intolerant to Positive Airway Pressure (PAP) therapy and sub-therapeutic to oral appliance therapy.
Hypothesis
1. There is a difference between Continuous Positive Airway Pressure (CPAP) vs CPAP/Oral Appliance (OA) connect vs CPAP/OA disconnected in terms of:
- Apnea Hypopnea Index (AHI) reduction
- Amount of side effects
- Amount of Leaks
- Hours of use (compliance)
- CPAP pressure
2. There is a difference between connected and disconnected for the following symptoms:
- Epworth sleepiness Scale (ESS)
- Functional Outcomes of Sleep Questionnaire (FOSQ)
- Side effects Study Design - randomized prospective parallel
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
- Single (Participant)
入排标准
- 年龄范围
- 18 Years 至 —（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 是
入选标准
- •Baseline diagnosis AHI > or = 5 plus ESS . or =
- •PAP Intolerance
- •Partial Response to oral appliance therapy: AHI > 5
- •Age: > 18
排除标准
- •History of daily use of alcohol, narcotics or Central Nervous System (CNS) depressants.
- •Diagnosis of Central Sleep Apnea
- •Pregnancy
- •Edentulous
- •Prisoners
结局指标
主要结局
Intolerance Questionnaire
时间窗: 2 months
This questionnaire consists of 4 questions to determine the frequency of 4 typical side-effects from positive airway pressure therapy. The score ranges from 0 to 16 (4 questions, 0-4 points per each). The higher value represent worse side effects.
PAP Pressure
时间窗: 2 months
The pressure required to treat the patient successfully
Leaks
时间窗: 2 months
The Liters/Minute of leaking of the PAP machine
Hours of Use
时间窗: 2 months
The average hours of use per night of each of the combination therapies
Functional Outcomes Sleep Questionnaire (FOSQ)
时间窗: 2 months
FOSQ is a disease specific quality of life questionnaire to determine how sleepiness interferes one's quality of life. The total score range from 5 to 20 (10 questions, 1-4 points per each). The lower values represent a worse quality of life.
Apnea-Hypopnea Index
时间窗: 2 months
Episodes per hour that the patient experiences apneas and/or hypopneas
Epworth Sleepiness Scale (ESS)
时间窗: 2 months
The ESS is a self-administered questionnaire with 8 questions. The score can range from 0 to 24. The higher the ESS score, the higher that person's average sleep propensity in daily life.
次要结局
未报告次要终点
研究者
Joseph Adame
J. Michael Adame, DDS, Principal Investigator
Adame, J. Michael, D.D.S.