The Impact of Daily Sinus Irrigation on Nasal Symptoms in Continuous Positive Airway Pressure (CPAP) Users - A Pilot Study
试验速览
- 阶段
- 不适用
- 入组人数
- 30
- 试验地点
- 2
- 主要终点
- RQLQ (Rhinoconjunctivitis Quality of Life Questionnaire)
研究概览
简要总结
Continuous positive airway pressure (CPAP) is the most commonly used treatment for obstructive sleep apnea. Nasal symptoms such as dryness, itching and congestion are common in CPAP users. Nasal and sinus saline irrigation has been shown to improve these symptoms in individuals with chronic nasal congestion and sinusitis. This is an 8 week study that investigates whether daily saline nasal and sinus irrigation reduces nasal symptoms in patients using CPAP, improves quality of life and CPAP compliance.
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)
入排标准
- 年龄范围
- 18 Years 至 90 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Apnea/hypopnea index ≥ 10
- •A documented successful CPAP titration
排除标准
- •Conditions that in the judgment of the investigator would interfere with subject participation in the study
- •History of sinus or nasal surgery
- •History of psychiatric illness
- •Use of sleep aids, sedatives or narcotics
- •Use of oral of subcutaneous anti-coagulants (i.e. warfarin, enoxaparin)
- •Bilevel or other nocturnal ventilation other than CPAP
- •Use of supplemental oxygen
- •Pregnancy or lactating
- •Inability or unwillingness to provide informed consent
- •Inability to perform baseline measurements
- •Inability to be contacted by phone
结局指标
主要结局
RQLQ (Rhinoconjunctivitis Quality of Life Questionnaire)
时间窗: 4 weeks
A 28-item, self administered questionnaire measuring nasal symptoms and other domains, including activity limitations and eye symptoms. Subjects will be asked to rate their symptoms on a 7-point scale (0=no impairment, 6=severely impaired). Change in RQLQ with daily saline irrigation in CPAP users is the primary outcome of interest.
次要结局
- Epworth Sleepiness Scale(4 weeks)
- SF-36(4 weeks)
- CPAP compliance(4 weeks)