Effect of Acetazolamide on Central Sleep Apnea Related to Opium Consumption
试验速览
- 阶段
- 4 期
- 入组人数
- 12
- 试验地点
- 1
- 主要终点
- Changes in Central Apnea Index
研究概览
简要总结
Acetazolamide improves central sleep apnea related to opium consumption.
详细描述
This is a double-blind, placebo-controlled, cross-over designed study to evaluate the effect of acetazolamide on central apneas in opium-user patients.
We are going to invite 12 eligible patients to enter our study. this sample will be obtained from the referral patients to Masih Daneshvari hospital sleep Lab. Eligible patients will undergo a full night polysomnography (PSG) to have a new measure of apnea indexes as baseline. Epwoth Sleepiness Scale Questionnaire (ESS) will be filled by the patient the night of the study.also an arterial blood sample will be obtained at the morning of each study. if the patient have more than 5 central apneas in each hour he/she will be scheduled to randomly receive a box containing 6 capsules to use one hour before bedtime at coming nights. The prescriber physician who will also score the tests and the patients are unaware either these capsules are acetazolamide 250mg or placebo. at 6th night we will perform PSG together with ESS questionnaire and arterial blood gas (ABG). after 2 weeks washout the patient receive another box containing 6 capsules with similar appearance to previous ones. If the patient receives acetazolamide in the first six nights, he/she will receive placebo in the second phase of the study and if the patient receives placebo in the first phase, he/she will receive acetazolamide in the second phase.
after the second 6 days, the third PSG will be performed plus ESS measurement and morning ABG sampling. Coded polysomnograms will be scored blindly.
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
- Triple (Participant, Investigator, Outcomes Assessor)
入排标准
- 年龄范围
- 18 Years 至 —（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Opium or opioid use for at least two months in a daily manner
- •Presence of five or more central sleep apnea per hour in a full-night recorded PSG
排除标准
- •Congestive heart failure
- •living in high altitude
- •Chronic Obstructive Pulmonary Disease (COPD)
- •Carbon dioxide partial pressure (pCO2) elevation due to other respiratory diseases
- •Body Mass Index (BMI) > 32
- •Obesity Hypoventilation Syndrome
- •Severe renal or liver disorders
- •Using Benzodiazepine
- •Using Theophylline
研究组 & 干预措施
#1 (Acetazolamide-placebo)
The arm #1 consists of 6 eligible patients who receive Acetazolamide 250mg once daily an hour before sleep for first six nights and after two weeks washout they receive placebo for six nights in the same order. After each six-day period they undergo polysomnography.
干预措施: Acetazolamide-placebo (Drug)
#2 (Placebo-acetazolamide)
The arm #2 consists of 6 eligible patients who receive placebo once daily an hour before sleep for first six nights and after two weeks washout they receive acetazolamide 250mg for six nights in the same order. After each six-day period they undergo polysomnography.
干预措施: Placebo-acetazolamide (Drug)
结局指标
主要结局
Changes in Central Apnea Index
时间窗: baseline and six days
次要结局
- Changes in daytime sleepiness, as measured by Epworth Sleepiness Scale (0-24)(baseline and six days)
研究者
Parisa Adimi
Associate Professor of Medicine
Shahid Beheshti University of Medical Sciences