Effect of AD128 on Obstructive Sleep Apnea Severity: a Randomized, Placebo-controlled, Double-blind, Cross-over Study
试验速览
- 阶段
- 2 期
- 状态
- 已完成
- 发起方
- 入组人数
- 15
- 试验地点
- 1
- 主要终点
- Apnea-hypopnea index (AHI)
研究概览
简要总结
This study evaluates the combination of two drugs (AD128), to treat obstructive sleep apnea (OSA) severity. After a baseline evaluation and during 7 days, half of the participants will randomly receive this drug combination (AD128) and the other will receive a placebo, i.e. a drug without pharmaceutical effect. Neither the participants, nor the investigators will know in which arm participants are until the end of the study. After one week of trial, an evaluation will be perform and will be follow by one week without any treatment. During the third and last week of trial, there will be a crossover of the groups, i.e. the participants of the first group who took the two drugs (AD128) during the first week will take a placebo and those who took the placebo will take the drugs combination.
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)
盲法说明
Evaluators, investigators and patients will be blinded to treatment allocation. Treatments will be prepared and conditioned by the Pharmacy Service of the University Hospital of Lausanne according to a randomisation list performed by an independent statistician. The Pharmacy service is completely independent from the Center for Investigation and Research in Sleep (CIRS). Unblinding will be performed after statistical analysis is completed by a statistician blinded to treatment assignment.
入排标准
- 年龄范围
- 18 Years 至 65 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Adults (>18 years and ≤ 65 years)
- •New or previous diagnosis of OSA with an AHI > 15/h on a polygraphic or polysomnographic recording (Participants already treated with continuous positive airway pressure (CPAP) or mandibular advancement device can be included but a 7-days wash-out period is required before the beginning of the protocol and CPAP usage will not be possible during the whole protocol duration),
- •Informed Consent as documented by signature (Appendix Informed Consent Form)
排除标准
- •History of seizures,
- •History of glaucoma,
- •History of benign prostatic hyperplasia, organic miction disorder or urinary retention,
- •Gastrointestinal disease (e.g. stenosis, occlusion, ulcerative colitis, toxic megacolon, hiatal hernia...)
- •Cardiac arrhythmia,
- •History of bipolar disorder,
- •Use of respiratory stimulants or depressants,
- •Use of Hypnotics,
- •Use of Central nervous system stimulants,
- •Use of Monoamine oxidase inhibitors (MAOIs) antidepressant,
- •Major depressive disorder,
- •Central sleep apnea representing more than 10% of all respiratory events
- •Contraindications to the class of drugs under study, e.g. known hypersensitivity or allergy to class of drugs or the investigational product,
- •Pregnant or breast feeding female participants or participants who intend to become pregnant during the study (However, there is no contraindication to contraception),
- •Other clinically significant concomitant disease states (renal failure, hepatic dysfunction, severe cardiovascular or respiratory disease, myasthenia gravis, cerebral sclerosis),
- •Known or suspected non-compliance, drug or alcohol abuse,
- •Inability to follow the procedures of the study, e.g. due to language problems, psychological disorders, dementia, etc. of the participant,
- •Participation in another study with investigational drug within the 30 days preceding and during the present study
- •Use or morphinic and derivatives which may influence sleep,
- •Refusal to be informed in case of incidental findings.
研究组 & 干预措施
AD128
The study specific intervention includes per oral administration of two capsules of AD128, once daily, just before lights out, for 7 days.
干预措施: AD128 (Drug)
placebo
Two placebo capsules (Mannitol) will be administered for the control intervention once daily, just before light outs, for one week.
干预措施: Mannitol (Drug)
结局指标
主要结局
Apnea-hypopnea index (AHI)
时间窗: Day 7 and 21
Change from baseline AHI (events/h) measured via polysomnography between the week of investigational treatment (AD128) and the week of placebo treatment.
次要结局
- Hypoxic load(Day 7 and 21)
- Oxygen desaturation index (ODI)(Day 7 and 21)
- Oxygen desaturation index (ODI) in REM and NREM(Day 7 and 21)
- Hypoxic load in REM and NREM(Day 7 and 21)
- Arousal index(Day 7 and 21)
- Arousal index in REM and NREM(Day 7 and 21)
- Pulse wave amplitude (PWA) drops(Day 7 and 21)
- Pulse wave amplitude (PWA) drops in REM and NREM(Day 7 and 21)
- Apnea-hypopnea index (AHI) in REM and NREM(Day 7 and 21)
- Percentage of REM sleep(Day 7 and 21)
- Percentage of N1(Day 7 and 21)
- Percentage of N2(Day 7 and 21)
- Percentage of N3(Day 7 and 21)
- Percentage of alpha wave(Day 7 and 21)
- Percentage of beta wave(Day 7 and 21)
- Percentage of gamma wave(Day 7 and 21)
- Percentage of theta wave(Day 7 and 21)
- Percentage of delta wave(Day 7 and 21)
- Reaction time PVT(Day 7 and 21)
- Lapse PVT(Day 7 and 21)
- Chronic Excessive daytime sleepiness (EDS)(Day 7 and 21)
- Acute Excessive daytime sleepiness (EDS)(Day 7 and 21)
- Sleep quality(Day 7 and 21)
- Fatigue(Day 7 and 21)
- Systolic and diastolic blood pressure(Day 7 and 21)
研究者
Raphael Heinzer
Prof. Raphael Heinzer
Centre Hospitalier Universitaire Vaudois