Enhance the Restorative Power of Sleep Through TES-TI Power Naps
试验速览
- 阶段
- 不适用
- 状态
- 招募中
- 入组人数
- 25
- 试验地点
- 1
- 主要终点
- Change in slow waves
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 mental fatigue.
Participants will attend 2 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 project aims to use transcranial electrical stimulation with temporal interference (TES-TI) to enhance the production of sleep slow waves, boosting the restorative power of sleep and mitigating cognitive impairment (mental fatigue) and its underlying cause (brain fatigue).
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Basic Science
- 盲法
- Single (Participant)
入排标准
- 年龄范围
- 18 Years 至 75 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 是
入选标准
- •Adults aged 18-75 of any gender identity
- •Self-reported non-restorative sleep, as measured by a REST-Q score
- •English-speaking (able to provide consent and complete questionnaires)
- •Capable of taking daytime naps
- •US Citizen
排除标准
- •Any current or history of neurological disorders or acquired neurological disease (e.g. stroke, traumatic brain injury), including intracranial lesions
- •History of inpatient psychiatric hospitalization
- •History of head trauma resulting in prolonged loss of consciousness; or a history of >3 grade I 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, history of abnormal (epileptiform) EEG, or family history of treatment resistant epilepsy except for 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 head
- •Any medical devices or implants (i.e. cardiac pacemaker, medication infusion pump, cochlear implant, vagal nerve stimulator)
- •Dental implants
- •Permanent retainers
- •Any hair braid, dreadlocks, hair pieces, or extensions which cannot be taken out before the study sessions
- •Any head coverings or headdress that participant feels uncomfortable removing for the purposes of study sessions
- •Any medication that may alter seizure threshold taken during the study i.e., ADHD stimulants (Adderall, amphetamine); Tricyclic/atypical antidepressants (amitriptyline, doxepine, imipramine, maprotiline, nortriptyline, bupropion); 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
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
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 slow waves
时间窗: Baseline to 1 month
Researchers will do a power analysis on high density EEG data for slow wave frequency (3-5Hz) and see if there is increase in this frequency range during/post stimulation.
Change in sleep quality and mood
时间窗: Baseline to 1 month
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.
次要结局
未报告次要终点