NCT05527457已完成1 期
Effects of BAY2586116 on Obstructive Sleep Apnoea (OSA) Severity Informed by Upper Airway Physiology and the Role of Route of Breathing
适应症
干预措施
相关药物
试验速览
- 阶段
- 1 期
- 状态
- 已完成
- 入组人数
- 10
- 试验地点
- 1
- 主要终点
- Individual comparison between physiology changes in Pcrit during KOALA part A (NCT04236440) between BAY2586116 vs. placebo and change in AHI with BAY2586116 vs. placebo (nasal breathing) during current study
研究概览
简要总结
This investigator-initiated study aims to determine the effects of BAY2586116 (a novel TASK channel blocker nasal spray) on sleep apnoea severity and the potential influence of route of breathing.
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
Participants and outcomes assessor (sleep scorer) blinded to all 3 study arms. Investigator blinded to 2/3 arms.
入排标准
- 年龄范围
- 18 Years 至 —（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 是
入选标准
- •Male or female participants aged 18 years or older at screening
- •Must have completed Part A of the KOALA study (NCT04236440)
- •Must be willing to sleep three nights in the sleep lab without OSA therapy (This includes continuous positive airway pressure therapy (CPAP) and/or a mandibular advancement device (MAD))
- •Must be willing to refrain from drinking alcohol on the study days.
- •Must be willing to limit consumption of tobacco to four cigarettes or one cigar a day and not smoke while at the sleep laboratory. This might be up to 12 hours.
- •Must be willing to limit caffeinated beverage intake (coffee, tea, cola, and other soft drinks) to 400 mg / day or less of caffeine and not to be used within 4 hours of bedtime on study days.
- •Contraceptive use required by men or women according to the methods of contraception for those participating in clinical studies
排除标准
- •Any medications or herbal supplements that may interfere or be contraindicated with the study drug as determined by the investigator
- •Severely impaired breathing within two days prior to randomization (e.g., acute nasal congestion during upper airway infection).
- •known allergies or hypersensitivities to the study drugs (active substances or excipients of the preparations).
- •Any other condition which at the discretion of the investigator would make the participant unsuitable for participation in the study and will not allow participation for the full planned study period (e.g., active malignancy or other condition limiting life expectancy to less than 12 months)
研究组 & 干预措施
BAY2586116 (oro-nasal breathing night)
Experimental
BAY2586116 nasal spray, taken before bedtime. Dosage is taken on one instance for one night only for the oro-nasal breathing night.
干预措施: BAY2586116 (Drug)
Placebo
Placebo Comparator
Placebo (saline) nasal spray, taken before bedtime. Dosage is taken on one instance for one night only.
干预措施: Placebo (Drug)
BAY2586116 (nasal breathing only night)
Experimental
BAY2586116 nasal spray, taken before bedtime. Dosage is taken on one instance for one night only for the nasal only breathing night.
干预措施: BAY2586116 (Drug)
结局指标
主要结局
Individual comparison between physiology changes in Pcrit during KOALA part A (NCT04236440) between BAY2586116 vs. placebo and change in AHI with BAY2586116 vs. placebo (nasal breathing) during current study
时间窗: Two non-consecutive single night sleep studies (BAY2586116 nasal only breathing night vs. placebo night) conducted approximately 1 week apart
Individual changes in the critical closing pressure of the upper airway during sleep (Pcrit- measured in cmH2O) in KOALA part A (NCT04236440) will be compared to changes in the apnoea/hypopnoea index (AHI- measured as # of apnoeas and hypopneas per hour of sleep) between BAY2586116 (nasal breathing night) vs. placebo night
次要结局
- Change in OSA severity (BAY2586116 nasal only breathing night vs. placebo night)(Two non-consecutive single night sleep studies (BAY2586116 nasal only breathing night vs. placebo night) conducted approximately 1 week apart)
- Change in OSA severity (BAY2586116 oro-nasal breathing night vs. placebo night)(Two non-consecutive single night sleep studies (BAY2586116 oro-nasal breathing night vs. placebo night) conducted approximately 1 week apart)
- Change in OSA severity (BAY2586116 oro-nasal breathing night vs. BAY2586116 nasal only breathing night)(Two non-consecutive single night sleep studies (BAY2586116 oro-nasal breathing night vs. BAY2586116 nasal only breathing night) conducted approximately 1 week apart)
- Change in sleep efficiency (BAY2586116 nights vs. placebo night)(Three non-consecutive single night sleep studies (BAY2586116 nasal only breathing night, BAY2586116 oro-nasal breathing night and placebo night) conducted approximately 1 week apart)
- Change in arousal index (BAY2586116 nights vs. placebo night)(Three non-consecutive single night sleep studies (BAY2586116 nasal only breathing night, BAY2586116 oro-nasal breathing night and placebo night) conducted approximately 1 week apart)
- Change in respiratory control (BAY2586116 nights vs. placebo night)(Three non-consecutive single night sleep studies (BAY2586116 nasal only breathing night, BAY2586116 oro-nasal breathing night and placebo night) conducted approximately 1 week apart)
- Change in airway collapsibility (BAY2586116 nights vs. placebo night)(Three non-consecutive single night sleep studies (BAY2586116 nasal only breathing night, BAY2586116 oro-nasal breathing night and placebo night) conducted approximately 1 week apart)
- Placebo OSA endotypes (outcomes 8-11) and whether they are associated with changes in OSA severity (BAY2586116 nights vs. placebo night)(Three non-consecutive single night sleep studies (BAY2586116 nasal only breathing night, BAY2586116 oro-nasal breathing night and placebo night) conducted approximately 1 week apart)
- Change in nadir overnight hypoxemia (BAY2586116 nights vs. placebo night)(Three non-consecutive single night sleep studies (BAY2586116 nasal only breathing night, BAY2586116 oro-nasal breathing night and placebo night) conducted approximately 1 week apart)
- Change in sleep architecture (BAY2586116 nights vs. placebo night)(Three non-consecutive single night sleep studies (BAY2586116 nasal only breathing night, BAY2586116 oro-nasal breathing night and placebo night) conducted approximately 1 week apart)
- Change in hypoxic burden (BAY2586116 nights vs. placebo night)(Three non-consecutive single night sleep studies (BAY2586116 nasal only breathing night, BAY2586116 oro-nasal breathing night and placebo night) conducted approximately 1 week apart)
- Change in the respiratory arousal threshold (BAY2586116 nights vs. placebo night)(Three non-consecutive single night sleep studies (BAY2586116 nasal only breathing night, BAY2586116 oro-nasal breathing night and placebo night) conducted approximately 1 week apart)
研究者
Professor Danny Eckert
Director, Adelaide Institute for Sleep Health
Flinders University
研究点 (1)
Loading locations...
相似试验
已完成
1 期
A Study to Learn More About How Safe BAY2586116 is, How it Affects the Body, How it Moves Into, Through and Out of the Body at Different Doses in Healthy Japanese Male Participants After Taking Single and Multiple Doses Through the NoseObstructive Sleep ApneaNCT04872387Bayer36
已完成
2 期
Study on the Safety of Drug BAY2586116 and How it Works in Patients With Obstructive Sleep Apnea (a Sleep Disorder Caused by the Narrowing and Collapse of the Airway During Sleep) Including the Blood Level of the Drug and Effect of Its Doses and Routes of AdministrationSleep Apnea, ObstructiveNCT04236440Bayer14
撤回
3 期
An Exploratory Study of NBI-34060 Capsules and Next Day FunctioningInsomniaNCT00525941Neurocrine Biosciences
已完成
3 期
A Study to Evaluate Efficacy and Safety of Oral BAY63-2521 in Patients With Pulmonary Arterial Hypertension (PAH)Pulmonary HypertensionNCT00810693Bayer445
已完成
2 期
Efficacy and Activity of BAY 43-9006 in Patients With Recurrent and/or Metastatic Head and Neck CancerHead and Neck NeoplasmsNCT00199160Jules Bordet Institute60