Reboxetine for Obstructive Sleep Apnoea After Upper Airway Surgery: a Randomised, Double-blind, Placebo-controlled Study
试验速览
- 阶段
- 2 期
- 状态
- 招募中
- 入组人数
- 20
- 试验地点
- 1
- 主要终点
- Data capture efficiency
研究概览
简要总结
This pilot study will establish the feasibility of a larger trial to investigate whether reboxetine, a medication used to treat depression, can reduce the severity of obstructive sleep apnea (OSA) including increased blood oxygenation in post-surgical OSA patients where positive airway pressure (CPAP) therapy is either frequently poorly tolerated or not an option immediately post surgery. In this randomized, placebo-controlled, double-blind study, participants will use at-home sleep monitoring equipment before and after surgery plus measures of oxygenation. They will be prescribed either reboxetine or a placebo for seven days after surgery and complete questionnaires at the beginning and end of the study.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Crossover
- 主要目的
- Other
- 盲法
- Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
盲法说明
Identical capsule for placebo and study drug prepared by study pharmacist
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
- •Age >18 years
- •Undergoing elective upper airway surgery
- •History of obstructive sleep apnoea (OSA)
排除标准
- •Clinically significant cardiac disease (e.g., arrhythmia, coronary artery disease, or cardiac failure)
- •History of clinically significant urinary retention, bladder outlet obstruction, or benign prostatic hyperplasia
- •Poorly controlled hypertension
- •History of schizophrenia, schizoaffective disorder or bipolar disorder according to Diagnostic and Statistical Manual of Mental Disorders-V or International Classification of Disease 10th edition criteria
- •History of attempted suicide or suicidal ideation within 1 year prior to screening, or current suicidal ideation
- •Narrow angle glaucoma
研究组 & 干预措施
Placebo
Placebo sugar pill in the form of one capsule, taken before bedtime. Dosage is taken for 7 nights post-surgery.
干预措施: Placebo (Drug)
Reboxetine
7-day course of 4mg reboxetine, taken nightly before bed time. Reboxetine will be taken for 7-nights post-surgery.
干预措施: Reboxetine 4 MG Oral Tablet (Drug)
结局指标
主要结局
Data capture efficiency
时间窗: 14 days
The percentage of successful data collection nights versus missed nights of at-home oximetry for this feasibility study.
Treatment protocol adherence
时间窗: 7 days
The percentage of total doses of the study drug (reboxetine or placebo) that were taken versus prescribed (assessed via pill counts) for this feasibility study.
次要结局
- Apnoea-hypopnea hndex (AHI)(14 days)
- Time spent below 90% SpO2(14 days)
- Perceived sleep quality measured via the Leeds Sleep Evaluation Questionnaire(14 days)
- Daytime sleepiness(14 days)
- nadir SpO2(14 days)
- mean SpO2(14 days)
- Sleep efficiency (%)(14 days)
- Study enrolment rate(12 months)
- Oxygen desaturation index (ODI)(14 days)
- Sleep duration(14 days)
- Insomnia Severity Score(14 days)
研究者
Professor Danny Eckert
Director, Adelaide Institute for Sleep Health
Flinders University