Effects of a Time-delayed, Pulsatile Caffeine Formula on Sleep Inertia, Morning Cognition, Affect and Sleepiness in Healthy Volunteers
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 32
- 试验地点
- 2
- 主要终点
- Acute Sleep Inertia Questionnaire
研究概览
简要总结
Sleep inertia (sometimes also referred to as sleep drunkenness) is a disabling state of increased sleepiness, impaired mood and reduced vigilance immediately upon awakening. Sleep inertia is highly prevalent in various neurological diseases, including neurodegenerative, affective and circadian sleep-wake rhythms disorders, as well as in frequent societal conditions such as chronic sleep restriction, jetlag and shiftwork. Reactive countermeasures against sleep inertia, i.e., strategies implemented upon wake-up, are not sufficiently effective, yet current recommendations are limited to proactive strategies, including long enough sleep at optimal times of day. These recommendations are not always easy and sometimes impossible to apply. To address this unmet medical need, the investigators developed an innovative, time-controlled, pulsatile-release formulation of 160 mg caffeine targeting an efficacious dose briefly before planned awakening.
详细描述
Sleep inertia is a disabling state of grogginess and impaired vigilance immediately upon awakening. The adenosine receptor antagonist, caffeine, is widely used to reduce sleep inertia symptoms, yet the initial, most severe impairments are hardly alleviated by post-awakening caffeine intake. To ameliorate this disabling state more potently, the investigators developed an innovative, delayed, pulsatile-release caffeine formulation targeting an efficacious dose briefly before planned awakening.
The investigators comprehensively test this formulation in two placebo-controlled, double-blind, cross-over studies. First, the investigators establish the in vivo caffeine release profile in young men. Subsequently, they investigate the formulation's ability to improve sleep inertia in sleep-restricted volunteers. Following oral administration of 160 mg caffeine at habitual bedtime [22:30], the investigators keep the participants awake until 03:00, to increase sleep inertia symptoms upon scheduled awakening [at 07:00]. Immediately upon awakening, the investigators quantify subjective state, psychomotor vigilance, cognitive performance, and the cortisol awakening response. They also record polysomnography during nocturnal sleep and a 1-hour nap opportunity at 08:00.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Crossover
- 主要目的
- Basic Science
- 盲法
- Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
入排标准
- 年龄范围
- 18 Years 至 34 Years（Adult）
- 性别
- Male
- 接受健康志愿者
- 是
入选标准
- •male sex in order to avoid the potential impact of menstrual cycle on sleep physiology or HPA axis activity,
- •age within the range of 18 to 34 years,
- •a body-mass-index below 25,
- •an Epworth Sleepiness Score (ESS) below 10,
- •habitual sleep onset latency below 20 minutes,
- •regular sleep-wake rhythm with bedtime between 11 pm and 1 am,
- •absence of any somatic or psychiatric disorders,
- •no acute or chronic medication intake,
- •non-smoking,
- •no history of drug abuse (lifetime use > 5 occasions, except occasional cannabis use)
- •caffeine consumption of less than 4 units per day (coffee, tea, chocolate, cola, energy drinks)
排除标准
- •Failure to meet inclusion criteria
结局指标
主要结局
Acute Sleep Inertia Questionnaire
时间窗: At 07:00 hours after caffeine and placebo administration
Modified questionnaire to assess subjective ratings of sleep inertia on physiological, emotional, cognitive and behavioral levels.
次要结局
- Psychomotor vigilance task(Between 07:15-07:30 hours after caffeine and placebo administration)
- Cortisol awakening response(Between 07:00-08:00 hours after caffeine and placebo administration)
- Polysomnographic recording of nocturnal sleep(Between 03:00-07:00 hours after caffeine and placebo administration)
- Caffeine Effects Questionnaire(Between 07:15-08:00 hours after caffeine and placebo administration)
- Positive and Negative Affect Schedule(Between 07:00-08:15 hours after caffeine and placebo administration)
- N-back task(Between 07:30-07:40 hours after caffeine and placebo administration)
- d2 attention task(Between 07:40-07:45 hours after caffeine and placebo administration)
- Polysomnographic recording of morning nap opportunity(Between 08:00-09:00 hours after caffeine and placebo administration)
研究者
Hans-Peter Landolt
Research Director
University of Zurich