Repurposing Dexmedetomidine as an Orally Administered Sleep Therapeutic
试验速览
- 阶段
- 1 期
- 状态
- 已完成
- 入组人数
- 15
- 试验地点
- 1
- 主要终点
- Hemodynamic Stability (Phase I)
研究概览
简要总结
The broad objective of this investigation is to assess the safety and efficacy of oral therapy with dexmedetomidine for the induction and maintenance of restful sleep.
详细描述
Sleep is a basic human function that occupies approximately one-third of our lives. Much of what is known about the benefits of sleep in humans has been obtained from studies of patients with insomnia, the most common sleep disorder with a reported prevalence of 10 to 15%. Unfortunately, insomnia is an independent risk factor for acute myocardial infarction, coronary heart disease, heart failure, hypertension, diabetes, and death. More so, sleep disturbances lead to neurocognitive deficits such as delirium and psychosis. However, the principal medications (i.e. benzodiazepines, zolpidem) currently used to treat insomnia are associated with side effects such as daytime sedation, delirium, anterograde memory disturbance, and complex sleep-related behaviors. We recently found that a nighttime intravenous bolus administration of dexmedetomidine was associated with normal sleep architecture comprising of rapid eye movement (REM) and non-REM (N1, N2, N3) sleep, with improved next-day psychomotor vigilance performance compared to zolpidem. Presently, dexmedetomidine is only available in an intravenous formulation. The goal of this project is to develop dexmedetomidine, an alpha-2 receptor agonist, into an oral sleep therapeutic with a neurocognitive sparing profile.
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, Care Provider, Investigator)
入排标准
- 年龄范围
- 18 Years 至 50 Years（Adult）
- 性别
- All
- 接受健康志愿者
- 是
入选标准
- •Age between 18-50
- •Native English speaking
- •ASA physical status classification P1 and P2 (stable chronic condition)
- •Normal body habitus.
排除标准
- •Abnormal sleep habits
- •Sleeping less than 5 hours each night
- •Going to sleep before 9:00 PM or after 2:00 AM on a regular basis
- •Waking up before 5:00 AM or after 10:00 AM on a regular basis.
- •Takes medication that alters sleep, cognitive function, or both. -Has a history of a known neurological or psychiatric problem.
- •Younger than 18 or older than 50 years of age.
- •Known or suspected sleep disorder(s).
研究组 & 干预措施
Oral Dexmedetomidine, Then Placebo
This arm will enroll healthy control subjects, who will have an acclimation night followed by a night's sleep with oral dexmedetomidine and then a night's sleep with a placebo comparator.
干预措施: Dexmedetomidine (Drug)
Oral Dexmedetomidine, Then Placebo
This arm will enroll healthy control subjects, who will have an acclimation night followed by a night's sleep with oral dexmedetomidine and then a night's sleep with a placebo comparator.
干预措施: Saline Placebo (Other)
Placebo, Then Oral Dexmedetomidine
This arm will enroll healthy control subjects, who will have an acclimation night followed by a night's sleep with a placebo comparator and then a night's sleep with oral dexmedetomidine .
干预措施: Dexmedetomidine (Drug)
Placebo, Then Oral Dexmedetomidine
This arm will enroll healthy control subjects, who will have an acclimation night followed by a night's sleep with a placebo comparator and then a night's sleep with oral dexmedetomidine .
干预措施: Saline Placebo (Other)
结局指标
主要结局
Hemodynamic Stability (Phase I)
时间窗: Active study night, visit 3 or 4
Number of participants with (1) systolic blood pressure (SBP) \< 60 mmHg, diastolic blood pressure (DBP) \< 40 mmHg or decrease of SBP by ≥ 50 % from the baseline which is sustained over two consecutive minutes, (2) hypertension: SBP \> 180 mmHg, DBP \> 100 mmHg, or increase of SBP by ≥ 50 % from the baseline which is sustained over two minutes and, (3) bradycardia: heart rate (HR) \< 40 bpm or decrease by ≥ 50 % from the baseline sustained over two consecutive minutes.
Polysomnography Sleep Quality (Phase II).
时间窗: Active study night, visit 3 or 4
Number of participants who had EEG features of natural sleep. Relative quantities of spindles and k-complexes were used to assess approximation to natural sleep.
次要结局
- Performance on the Psychomotor Vigilance Task (Phase II)(Active study night, visit 3 or 4)
- Performance on the Motor Sequence Task (Phase II)(Active study night, visit 3 or 4)
- Subjective Sleep Quality (Phase II)(Active study night, visit 3 or 4)
研究者
Oluwaseun Johnson-Akeju, MD, MMSc
Assistant Professor in Anesthesia
Massachusetts General Hospital