Evaluation of SmartSleep Technology for Improving the Efficiency and Restorative Quality of Sleep in Healthy Adults in Order to Mitigate Cognitive Performance Deficits Due to Sleep Restriction and Emergency Awakenings
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 9
- 试验地点
- 1
- 主要终点
- Psychomotor Vigilance Test-Brief (PVT-B)
研究概览
简要总结
This study aims to assess whether slow wave sleep enhancement using SmartSleep technology benefits daytime cognitive performance during periods of chronic sleep restriction.
详细描述
Adequate healthy sleep is essential in spaceflight to ensure that astronauts maintain a high level of cognitive performance capability and do so without undue stress. There is a need for a technology that can improve sleep quality in space and biologically maximize the performance benefits of limited sleep duration, without unduly affecting the ability of astronauts to awaken abruptly and respond to an in-flight emergency. Sleep slow waves support system and synaptic consolidation by promoting specific patterns of neuromodulatory and electric activities, and subjective sleep quality is related to the size and number of slow waves that occur nightly.
This study will use SmartSleep (Philips) technology to determine what effect the device has on daytime cognitive performance after emergent awakenings from sleep in a chronic sleep restriction paradigm. The SmartSleep technology uses two small sensors in the headband to continuously detect the brain's slow wave sleep (delta/theta frequency) in real time, and a closed-loop algorithm customizes the timing and volume of tones to optimize the sleep pattern. Thus, the device uses "quiet audio tones" (sub-awareness) to increase slow waves, which can enhance sleep quality/depth, thereby enhancing subsequent waking cognitive performance without the unwanted sedating effects of medications on cognitive functions during emergency awakenings.
Subjects will be in the laboratory for 7 days/6 nights. Night 1 will be an adaptation night with 8-hours time in bed. Nights 2-5 will consist of 5 hours time in bed, followed by night 6 of a recovery 10 hours time in bed. During nights 2-5, subjects will receive one of four stimulation modalities using the SmartSleep wearable device. Subjects will receive all four modalities in a randomized order:
- Continuous Fixed Interval
- Block
- In-Phase Adjustable
- Sham: No auditory stimulation while wearing the SmartSleep headband
Cognitive performance testing and self-report surveys will be completed on a daily basis. A total of 12 healthy astronaut-like adults will be studied. Subjects will complete the 7-day study in groups of 4.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Crossover
- 主要目的
- Other
- 盲法
- Triple (Participant, Investigator, Outcomes Assessor)
盲法说明
The SmartSleep device will be programmed by investigators not involved in study execution. Subjects will wear the SmartSleep device each night and will be unaware of the order of stimulation modalities. In addition, both study personnel and those assessing outcomes will not be aware of the order of stimulation modalities.
入排标准
- 年龄范围
- 30 Years 至 55 Years（Adult）
- 性别
- All
- 接受健康志愿者
- 是
入选标准
- •Bachelor's degree or Master's degree (or the equivalent in work experience) in a relevant field, and/or military service.
- •Free of psychological/psychiatric conditions that preclude participation.
- •Self-reported regular sleep schedule; able to maintain their sleep schedule during the course of the study.
- •Self-reported sleep duration of 6-8.5 hrs per night (verified by 6 work days of ambulatory sleep monitoring with wrist actigraphy and daily logs).
- •Ability to read/write English.
排除标准
- •History of neurological, psychiatric, or other medical condition that excludes participation.
- •Current mania or psychosis.
- •Current depression as determined by the Beck Depression Inventory (Beck, 1996).
- •Alcohol or drug abuse in the past year based upon history and urine toxicology screen.
- •Excessive alcohol intake (≥ 21 drinks per week) or binge alcohol consumption (> 5 drinks per day).
- •Excessive caffeine consumption (> 650mg/day combining all caffeinated drinks regularly absorbed during the day).
- •Current smoker/tobacco user, or using nicotine replacement therapy. Those that have been nicotine-free for 30 days will be included.
- •Acute, chronic, or debilitating medical conditions, major Axis I psychiatric illness based on history, physical exam, blood and urine chemistries, and CBC.
- •Individuals who self-report a history of recurrent seizures or epilepsy or have a history of medical conditions that could increase the chance of seizures (e.g. stroke, aneurysm, brain surgery, structural brain lesion).
- •Cardiovascular, neurological, gastrointestinal, or musculoskeletal problems that exclude participation.
- •Major controlled or uncontrolled medical condition such as congestive heart failure, neuromuscular disease, renal failure, cancer, COPD, respiratory failure or insufficiency, or patients requiring oxygen therapy (as determined by self-report).
- •Currently working night, swing, split or rotating shift.
- •Current use or use of within the past month of a prescription or over-the-counter sleep medication or stimulant; use of psychoactive medication (based on self-report and review with a study clinician).
- •Pregnant or currently breast feeding
- •Prior history or diagnosis of any sleep disorder
- •High Risk of OSA based on STOP-BANG Questionnaire ("yes" on at least 4 of 8 questions)
- •High Risk of Restless Legs Syndrome (RLS) based on Cambridge-Hopkins Screening questionnaire
- •High Risk of Insomnia based on Insomnia Severity Index (score of 22 or higher)
- •Individuals who self-report severe contact dermatitis or allergy to silicone, nickel or silver.
- •Individuals who self-report moderate hearing loss.
- •Inability to achieve appropriate headband fit.
- •Planned travel across more than one time zone one month prior to and/or during the anticipated period of the study with SmartSleeps device use.
- •Intentional naps during the week.
研究组 & 干预措施
SmartSleep Continuous Fixed Interval modality
This study uses within subject comparison. For each subject, the order of 3 SmartSleep modalities for each of the 4 nights of sleep restriction will be randomized. All subjects will receive all 3 stimulation modalities and a SHAM condition.
This study arm tests the SmartSleep Continuous Fixed Interval stimulation modality during sleep relative to the SHAM condition. The Continuous Fixed Interval is the delivery of auditory tones a 1 Hz inter-tone interval stimulation.
干预措施: Philips SmartSleep Technology--Continuous Fixed Interval modality (Device)
SmartSleep Continuous Fixed Interval modality
This study uses within subject comparison. For each subject, the order of 3 SmartSleep modalities for each of the 4 nights of sleep restriction will be randomized. All subjects will receive all 3 stimulation modalities and a SHAM condition.
This study arm tests the SmartSleep Continuous Fixed Interval stimulation modality during sleep relative to the SHAM condition. The Continuous Fixed Interval is the delivery of auditory tones a 1 Hz inter-tone interval stimulation.
干预措施: Philips SmartSleep Technology--Block modality (Device)
SmartSleep Continuous Fixed Interval modality
This study uses within subject comparison. For each subject, the order of 3 SmartSleep modalities for each of the 4 nights of sleep restriction will be randomized. All subjects will receive all 3 stimulation modalities and a SHAM condition.
This study arm tests the SmartSleep Continuous Fixed Interval stimulation modality during sleep relative to the SHAM condition. The Continuous Fixed Interval is the delivery of auditory tones a 1 Hz inter-tone interval stimulation.
干预措施: Philips SmartSleep Technology--In-Phase Adjustable modality (Device)
SmartSleep Block modality
This study uses within subject comparison. For each subject, the order of 3 SmartSleep modalities for each of the 4 nights of sleep restriction will be randomized. All subjects will receive all 3 stimulation modalities and a SHAM condition.
This study arm tests the SmartSleep Block stimulation modality during sleep relative to the SHAM condition. The Block is the delivery of auditory tones for 5 seconds on versus 5 seconds off.
干预措施: Philips SmartSleep Technology--Continuous Fixed Interval modality (Device)
SmartSleep Block modality
This study uses within subject comparison. For each subject, the order of 3 SmartSleep modalities for each of the 4 nights of sleep restriction will be randomized. All subjects will receive all 3 stimulation modalities and a SHAM condition.
This study arm tests the SmartSleep Block stimulation modality during sleep relative to the SHAM condition. The Block is the delivery of auditory tones for 5 seconds on versus 5 seconds off.
干预措施: Philips SmartSleep Technology--Block modality (Device)
SmartSleep Block modality
This study uses within subject comparison. For each subject, the order of 3 SmartSleep modalities for each of the 4 nights of sleep restriction will be randomized. All subjects will receive all 3 stimulation modalities and a SHAM condition.
This study arm tests the SmartSleep Block stimulation modality during sleep relative to the SHAM condition. The Block is the delivery of auditory tones for 5 seconds on versus 5 seconds off.
干预措施: Philips SmartSleep Technology--In-Phase Adjustable modality (Device)
SmartSleep In-Phase Adjustable modality
This study uses within subject comparison. For each subject, the order of 3 SmartSleep modalities for each of the 4 nights of sleep restriction will be randomized. All subjects will receive all 3 stimulation modalities and a SHAM condition.
This study arm tests the SmartSleep In-Phase Adjustable stimulation modality during sleep relative to the SHAM condition. The In-Phase Adjustable is the constant stimulation with auditory tones delivered during each upstate of the slow wave.
干预措施: Philips SmartSleep Technology--Continuous Fixed Interval modality (Device)
SmartSleep In-Phase Adjustable modality
This study uses within subject comparison. For each subject, the order of 3 SmartSleep modalities for each of the 4 nights of sleep restriction will be randomized. All subjects will receive all 3 stimulation modalities and a SHAM condition.
This study arm tests the SmartSleep In-Phase Adjustable stimulation modality during sleep relative to the SHAM condition. The In-Phase Adjustable is the constant stimulation with auditory tones delivered during each upstate of the slow wave.
干预措施: Philips SmartSleep Technology--Block modality (Device)
SmartSleep In-Phase Adjustable modality
This study uses within subject comparison. For each subject, the order of 3 SmartSleep modalities for each of the 4 nights of sleep restriction will be randomized. All subjects will receive all 3 stimulation modalities and a SHAM condition.
This study arm tests the SmartSleep In-Phase Adjustable stimulation modality during sleep relative to the SHAM condition. The In-Phase Adjustable is the constant stimulation with auditory tones delivered during each upstate of the slow wave.
干预措施: Philips SmartSleep Technology--In-Phase Adjustable modality (Device)
SHAM condition
This study uses within subject comparison. For each subject, the order of 3 SmartSleep modalities for each of the 4 nights of sleep restriction will be randomized. All subjects will receive all 3 stimulation modalities and a SHAM condition.
This study arm is the SHAM condition, during which participants wore the SmartSleep device, however no auditory tones were delivered.
干预措施: Philips SmartSleep Technology--Continuous Fixed Interval modality (Device)
SHAM condition
This study uses within subject comparison. For each subject, the order of 3 SmartSleep modalities for each of the 4 nights of sleep restriction will be randomized. All subjects will receive all 3 stimulation modalities and a SHAM condition.
This study arm is the SHAM condition, during which participants wore the SmartSleep device, however no auditory tones were delivered.
干预措施: Philips SmartSleep Technology--Block modality (Device)
SHAM condition
This study uses within subject comparison. For each subject, the order of 3 SmartSleep modalities for each of the 4 nights of sleep restriction will be randomized. All subjects will receive all 3 stimulation modalities and a SHAM condition.
This study arm is the SHAM condition, during which participants wore the SmartSleep device, however no auditory tones were delivered.
干预措施: Philips SmartSleep Technology--In-Phase Adjustable modality (Device)
结局指标
主要结局
Psychomotor Vigilance Test-Brief (PVT-B)
时间窗: Days 3-6
The PVT is a simple reaction time test that requires participants to react, as quickly as possible, by pressing a response key as soon as a rolling number counter presented in a box in the center of the computer screen appears. The PVT is a validated and widely-used measure of vigilant attention that is sensitive to the effects of sleep loss. The primary outcome was the number of PVT lapses. The minimum number of PVT lapses is "0" and there is no maximum number of lapses, which are defined as response times \>355 ms. More PVT lapses indicates worse performance.
Slow-wave Activity
时间窗: Days 3-6
Total delta power measured during sleep
次要结局
- Digit Symbol Substitution Test (DSST)(Days 3-6)
- Descending Subtraction Task (DST)(Days 3-6)
- Robotic On-Board Trainer (ROBoT) Task(Days 3-6)