NCT00714740已完成4 期
Treatment of Patients With the Obstructive Sleep Apnea Syndrome at Altitude
适应症
相关药物
试验速览
- 阶段
- 4 期
- 状态
- 已完成
- 入组人数
- 49
- 试验地点
- 2
- 主要终点
- sleep disordered breathing, sleep structure, vigilance, subjective sleep quality acute mountain sickness
研究概览
简要总结
The purpose of the study is to investigate the effect of 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 70 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 (<800m)
- •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 or recently diagnosed (within the last 6 months) cardiovascular disease such as arterial hypertension, coronary artery or cerebrovascular 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 (<2600m).
- •Exposure to altitudes >1500m for >1 day within the last 4 weeks before the study
结局指标
主要结局
sleep disordered breathing, sleep structure, vigilance, subjective sleep quality acute mountain sickness
时间窗: during treatment while at altitude
次要结局
- blood pressure endothelial function(during treatment while at altitude)
研究者
研究点 (2)
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