Feasibility Study - Whether the Administration of the Dronabinol and PEA May Act as a Therapy for Obstructive Sleep Apnea
试验速览
- 阶段
- 2 期
- 发起方
- SciSparc
- 入组人数
- 30
- 试验地点
- 1
- 主要终点
- A Significant Change in AHI Index
研究概览
简要总结
This is a sponsored proof of concept study with the purpose to examine the safety, tolerability and feasibility of THX-110 (Dronabinol (synthetic Δ9-THC) and PEA) for the treatment of adults with Obstructive Sleep Apnea.
详细描述
This is a 30-day sponsor-initiated, open-label trial of the therapeutic treatment THX-110 (a combination of Dronabinol and PEA) in 30 adults with Obstructive Sleep Apnea (OSA). Participants will receive THX-110 for the duration of the trial. The goal for this pilot study is to provide initial safety, feasibility and tolerability data on THX-110 in an OSA population.
研究设计
- 研究类型
- Interventional
- 分配方式
- Na
- 干预模型
- Single Group
- 主要目的
- Treatment
- 盲法
- None
入排标准
- 年龄范围
- 20 Years 至 65 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •OSA diagnosis; OSA severity AHI: 15-30
- •Population aged 20-65
- •Gender: Males and Females
- •BMI < 30
- •OSA patients that cannot tolerate CPAP
- •OSA patients who use CPAP will not use the device during the entire duration of the study
排除标准
- •Severity of OSA outside the determined boundaries
- •Pregnancy
- •BMI > 30
- •Medical history of narcotic dependency
研究组 & 干预措施
THX-110
All participants will be titrated up on THX-110 (Dronabinol) dose during the first week of the trial (2.5mg Dronabinol for 3 days, 5mg Dronabinol for 3 days to 7.5mg Dronabinol for 3 days and finally increasing to 10mg for the remainder of the trial). Dronabinol will only be increased if the subject is tolerating the previous dose of Dronabinol and the Dronabinol may be reduced based on patient side-effects. Participants will be receiving 800mg PEA concomitantly.
干预措施: THX-110 (Drug)
结局指标
主要结局
A Significant Change in AHI Index
时间窗: 30 days
A significant change in AHI index, which assesses the quality of sleep before and after the treatment. The AHI is the number of apneas or hypopneas recorded during the study per hour of sleep. It is generally expressed as the number of events per hour. Based on the AHI, the severity of OSA is classified as follows: None/Minimal: AHI \< 5 per hour Mild: AHI ≥ 5, but \< 15 per hour Moderate: AHI ≥ 15, but \< 30 per hour Severe: AHI ≥ 30 per hour
次要结局
- A Change in Oxygen Desaturation Index (ODI)(30 days)