Optimal Dosage of Acetazolamide for Obstructive Sleep Apnea Treatment: a Parallel-group, Double-blind, Placebo-controlled, Randomized Trial
试验速览
- 阶段
- 4 期
- 状态
- 已完成
- 入组人数
- 91
- 试验地点
- 1
- 主要终点
- Apnea-hypopnea index (AHI)
研究概览
简要总结
Acetazolamide, a carbonic anhydrase inhibitor, has received some attention as potential treatment for obstructive sleep apnea (OSA). It produces a metabolic acidosis by excreting bicarbonate, thereby stimulating baseline ventilation. Evidence suggests that acetazolamide primarily improves ventilatory control instability (expressed as loop gain), which is an important contributor to the pathophysiology of OSA.
Few studies have assessed the efficacy of acetazolamide in patients with OSA. Since most of them had a small sample size and used different therapeutic dosages, clinical applications are currently limited. Therefore, this study aims to compare the effect of two acetazolamide dosages on the severity and pathophysiology of OSA.
详细描述
In this double-blind, parallel-group, controlled trial, eligible patients will be randomized into one of the following treatment arms: (1) placebo, (2) 250 mg of acetazolamide, or (3) 500 mg of acetazolamide. After 4 weeks, treatment outcome will be assessed by in-laboratory polysomnography. Additionally, arterial blood gas analysis and lung function tests will be performed before and during treatment.
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
- Double (Participant, Care Provider)
入排标准
- 年龄范围
- 18 Years 至 79 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •AHI between 15 and 65 events/hour
- •BMI < 35 kg/m²
排除标准
- •Craniofacial anomalies
- •Central sleep apnea (defined as central AHI > 25% of total AHI)
- •Contra-indications related to acetazolamide treatment
- •Hypersensitivity to sulphonamides or acetazolamide
- •Renal impairment, electrolyte imbalances, and/or adrenocortical insufficiency
- •Clinically significant metabolic, hepatic, and/or hematological disease
- •Chronic obstructive pulmonary disease
- •Closed-angle glaucoma
- •Conditions likely to affect OSA physiology: neuromuscular disease or other major neurological disorders, heart failure, or any other unstable major medical condition.
- •Intake of drugs that substantially stimulate or depress respiration, including benzodiazepines, opioids, theophylline, and pseudoephedrine
- •Inadequately treated sleep disorders other than OSA that would confound functional sleep assessment
- •Inability of the patient to understand and/or comply to the study procedures
- •Active psychiatric disease (psychotic illness, major depression, anxiety attacks, alcohol or drug abuse)
- •Pregnancy
研究组 & 干预措施
Low dose acetazolamide
Unembellished white tablets. The drug should be taken one hour before bedtime. Total treatment duration will be 6 weeks.
干预措施: Acetazolamide (Drug)
High dose acetazolamide
Unembellished white tablets. The drug should be taken one hour before bedtime. Total treatment duration will be 6 weeks.
干预措施: Acetazolamide (Drug)
Placebo
Matching placebo tablets. The drug should be taken one hour before bedtime. Total treatment duration will be 6 weeks.
干预措施: Placebo (Other)
结局指标
主要结局
Apnea-hypopnea index (AHI)
时间窗: 4 weeks
Change in AHI (events/hour) from baseline to follow-up. The AHI is a measure of sleep apnea severity that encompasses the frequency of apneas (cessations in breathing) and hypopneas (reductions in airflow).
次要结局
- Percent responders(4 weeks)
- Nocturnal oxygen saturation(4 weeks)
- Oxygen desaturation index (ODI)(4 weeks)
- Lung function parameters(4 weeks)
- Sleep-related quality of life: Functional Outcome of Sleep Questionnaire (FOSQ-10)(6 weeks)
- Pathophysiological traits(4 weeks)
- Daytime sleepiness: Epworth Sleepiness Scale (ESS)(6 weeks)
- Snoring intensity: Visual Analogue Scale (VAS)(6 weeks)
- Arterial blood gas measurements(4 weeks)