Continuous Positive Airway Pressure (CPAP) and Acetazolamide for Treatment of Patients With the Obstructive Sleep Apnea Syndrome at Altitude
试验速览
- 阶段
- 4 期
- 状态
- 已完成
- 入组人数
- 51
- 试验地点
- 1
- 主要终点
- sleep disordered breathing and oxygenation
研究概览
简要总结
The purpose of the study is to investigate the effect of nasal continuous positive airway pressure in combination with acetazolamide as a treatment for sleep related breathing disturbances in patients with the obstructive sleep apnea syndrome living at low altitude during a sojourn at moderate altitude.
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
- Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
入排标准
- 年龄范围
- 20 Years 至 80 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Obstructive sleep apnea syndrome, successfully on CPAP therapy
- •Residence at low altitude (< 800 m)
- •Obstructive apnea/hypopnea index >20/h and a complaint of excessive daytime sleepiness before introduction of CPAP therapy
- •> 15 oxygen desaturations/h (> 3% dips) during an ambulatory nocturnal pulse oximetry performed at the end of a 4-night period without CPAP
排除标准
- •Sleep disorders other than OSA
- •More than mild cardiovascular disease, unstable cardiovascular disease
- •Any lung disease, pulmonary hypertension
- •Chronic rhinitis
- •Treatment with drugs that affect respiratory center drive (benzodiazepines or other sedatives or sleep inducing drugs, morphine or codeine derivates), stimulants (modafinil, methylphenidate, theophylline)
- •Internal, neurologic or psychiatric disease that interfere with sleep quality
- •Previous intolerance to moderate or low altitude (< 2600 m)
- •Exposure to altitudes > 1500m for > 1 day within the last 4 weeks before the study
研究组 & 干预措施
acetazolamide
combination of acetazolamide and nocturnal continuous positive airway pressure ventilation
干预措施: acetazolamide (Drug)
acetazolamide
combination of acetazolamide and nocturnal continuous positive airway pressure ventilation
干预措施: nocturnal continuous positive airway pressure (Procedure)
placebo capsules
combination of placebo and nocturnal continuous positive airway pressure ventilation
干预措施: nocturnal continuous positive airway pressure (Procedure)
placebo capsules
combination of placebo and nocturnal continuous positive airway pressure ventilation
干预措施: placebo (Drug)
结局指标
主要结局
sleep disordered breathing and oxygenation
时间窗: day 2 and 3 at altitude
次要结局
- sleep quality, vigilance, acute mountain sickness, blood pressure(day 2 and 3 at altitude)