Rapid Eye Movement Restoration and Enhancement for Sleep-deprived Trauma-adaptation
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 72
- 试验地点
- 2
- 主要终点
- Change in minutes scored as REM sleep
研究概览
简要总结
The goal of this clinical trial is to find out whether stimulating the brain with electrical current during naps can increase certain kinds of brain activity that happen during sleep and lead to improvements in emotional health and stress resilience.
Participants will attend up to 3 study visits, each of which may last up to 4-5 hours. During these visits, participants will wear a high density electroencephalography (hdEEG) cap and take a nap.
详细描述
This is a single-blind, two-phase study. In the first phase, each participant will be assigned a nap length, a trigger region, a stimulation type (difference frequency, multipolar transcranial electrical stimulation with temporal interference (TES-TI), or phase modulation), and a stimulation start time relative to the appearance of spindles and sawtooth waves in their EEG. These parameters will be varied across and within participants who may undergo multiple naps in order to identify optimal parameters for enhancing REM sleep.
Phase II is a single-blind study comprised of 40 participants. Each participant will undergo two 90-minute naps with possible sham or non-sham stimulation conditions. The naps will be on 2 separate visits to the lab with at least 1 week between visits. Conditions on each visit are randomized and counterbalanced. During each visit, participants will complete both the REST-Q and SSS questionnaires. Full HDEEG will be applied as well as 4-16 stimulation electrodes. Participants will then undergo an emotion regulation task (face task) wherein they are presented with positive, negative, or neutral emotional stimuli. This is followed by a resting EEG recording, then a nap up to 90 minutes in duration. Either sham or non-sham stimuli will be applied at times during the nap period. Upon waking, the same questionnaires and emotion regulation tasks will be completed.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Single Group
- 主要目的
- Basic Science
- 盲法
- Single (Participant)
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
- •Adults aged 18-50 years
- •Medically healthy
- •English-speaking (able to provide consent and complete questionnaires)
- •Citizen or holding permanent resident status
- •Regular napper (1 or more naps per week)
排除标准
- •Any current or past history of neurological disorders or acquired neurological disease (e.g. stroke, traumatic brain injury), including intracranial lesions
- •History or head trauma resulting in prolonged loss of consciousness; or a history of >3 grade 1 concussions
- •Current history of poorly controlled headaches including intractable or poorly controlled migraines
- •Any systemic illness or unstable medical condition that may cause a medical emergency in case of a provoked seizure (cardiac malformation, cardiac dysrhythmia, asthma, etc)
- •History of seizures, diagnosis of epilepsy, histoy of abnormal (epileptiform) EEG, or family history of treatment resistant epilepsy with the exception of a single seizure of benign etiology (e.g. febrile seizures) in the judgment of a board-certified neurologist
- •Possible pregnancy or plan to become pregnant in the next 6 months
- •Any metal in the body
- •Any medical devices or implants (i.e. cardiac pacemaker, medication infusion pump, cochlear implant, vagal nerve stimulator) unless otherwise approved by the responsible MD
- •Dental implants containing metal
- •Any medication that may alter seizure threshold: ADHD stimulants (Adderall, amphetamine); tricyclic/stypical antidepressants (amitriptyline, doxepine, imipramine, maprotiline, nortriptyline, buproprion); antipsychotics (chlorpromazine, clozapine); bronchodilators (theophylline, aminophylline); antibiotics (fluoroquinolones, imipenem, penicillin, cephalosporins, metronidazole, isoniazid); Antivirals (valacyclovir, ritonavir); OTC antihistamines (diphenhydramine, Benadryl)
- •Claustrophobia (a fear of small or closed places)
- •Back problems that would prevent lying flat for up to two hours
- •Regular night-shift work (second or third shift)
研究组 & 干预措施
Stimulation followed by no stimulation
Phase 2 participants will receive stimulation during their nap at the first visit, and no stimulation during their nap at the second visit.
干预措施: Transcranial electrical stimulation with Temporal Interference (TES-TI) (Device)
No stimulation followed by stimulation
Phase 2 participants will not receive stimulation during their nap at the first visit, and receive stimulation during their nap at the second visit.
干预措施: Transcranial electrical stimulation with Temporal Interference (TES-TI) (Device)
结局指标
主要结局
Change in minutes scored as REM sleep
时间窗: Baseline to 4 weeks
EEG data will be recorded during sleep. The sleep EEG data is separated into stages (REM-NREM). This way, it is known how many minutes they spend in each stage.
Identify effective duration of the nap to maximize TES-TI effect on REM sleep
时间窗: Post nap (up to 90 minutes)
Researchers will compare the durations of nap (sleep duration on the EEG) within subjects across their multiple visits, as well as across subjects; correlating this with the stimulation parameters
Change in spindles after effective TES-TI intervention
时间窗: Post nap (up to 90 minutes)
Changes in sleep spindle density during sleep as measured by portable EEG device.
Change in sawtooth waves after effective TES-TI intervention
时间窗: Post nap (up to 90 minutes)
Researchers will do a power analysis on high density EEG data for sawtooth wave frequency (3-5Hz) and see if there is increase in this frequency range during/post stimulation.
Change in Spectral Power in Sawtooth Wave Frequency (3-5Hz)
时间窗: Baseline to 4 weeks
Change in score for vigilance task
时间窗: Baseline to post-nap (up to 90 minutes)
The vigilance task is a computerized reaction time task where participants are presented with a fixation point on a computer screen. At random, the fixation point will change appearance at which point the participant is to click a provided button as quickly as possible. The latency response is recorded automatically. Faster responses are indicative of higher vigilance.
Change in emotion response
时间窗: Baseline to post-nap (up to 90 minutes)
Emotional response is measured using an emotional processing task. This task involves viewing a series of emotionally charged images (60 positive, 60 negative, 60 neutral). Participants see a randomized set of these images and are asked to evaluate how pleasant and emotionally arousing each image is on respective 9-point Likert scales
Change in sleep quality and mood
时间窗: Baseline to post-nap (up to 90 minutes)
Sleep quality and mood will be assessed using the Restorative Sleep Questionnaire (REST-Q), a 9-item questionnaire assessing aspects of restorative sleep. Each item is scored on a 5-point Likert scale, scores range from 9-45. A higher score indicates a more restorative sleep
Change in sleepiness
时间窗: Baseline to post-nap (up to 90 minutes)
Sleepiness will be measured using the Stanford Sleepiness Scale (SSS). SSS is a measure of subjective alertness on a 7-point scale. A lower score on the scale indicated higher alertness.
Identify effective TES-TI parameters to trigger spindles
时间窗: Post nap (up to 90 minutes)
Researchers will do a power analysis on high density EEG data for spindle frequency (11-15Hz) and see if there is increase in this frequency range during/post stimulation.
次要结局
未报告次要终点