[{"data":1,"prerenderedAt":-1},["ShallowReactive",2],{"trial:NCT07090135":3,"trial-entities:NCT07090135":102,"trial-summary:NCT07090135":106},{"id":4,"nct_id":4,"org_study_id":5,"brief_title":6,"official_title":7,"overall_status":8,"completion_date":9,"status_verified_date":10,"last_update_date":11,"start_date":12,"sponsor_name":13,"lead_sponsor_class":14,"has_dmc":15,"brief_summary":16,"detailed_description":17,"conditions":18,"keywords":21,"study_type":22,"primary_purpose":23,"phases":24,"enrollment_info":26,"interventions":29,"primary_outcomes":37,"secondary_outcomes":45,"sex":46,"minimum_age":47,"maximum_age":48,"healthy_volunteers":15,"eligibility_criteria":49,"std_ages":74,"locations":77,"central_contacts":96,"overall_officials":98,"references":100,"see_also_links":101},"NCT07090135","2025-0481","Power Nap With TES-TI","Enhance the Restorative Power of Sleep Through TES-TI Power Naps","RECRUITING","2026-09","2026-07","2026-08-10","2025-12-19","University of Wisconsin, Madison","OTHER",true,"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.\n\nParticipants 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.","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).",[19,20],"Non-restorative Sleep","Healthy Volunteer",[],"INTERVENTIONAL","BASIC_SCIENCE",[25],"NA",{"count":27,"type":28},25,"ESTIMATED",[30],{"type":31,"name":32,"description":33,"armGroupLabels":34},"DEVICE","Transcranial electrical stimulation with Temporal Interference (TES-TI)","TES-TI uses specific electrode arrangement patterns to selectively stimulate the brain. Participants will wear an hdEEG (high density electroencephalography) cap which will allow intermittent periods of stimulation from TES-TI.",[35,36],"No stimulation followed by stimulation","Stimulation followed by no stimulation",[38,42],{"measure":39,"description":40,"timeFrame":41},"Change in slow waves","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\u002Fpost stimulation.","Baseline to 1 month",{"measure":43,"description":44,"timeFrame":41},"Change in sleep quality and mood","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.",[],"ALL","18 Years","75 Years",{"inclusion":50,"exclusion":56,"raw_text":73},[51,52,53,54,55],"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",[57,58,59,60,61,62,63,64,65,66,67,68,69,70,71,72],"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","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\u002Fatypical 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)","Inclusion Criteria:\n\n* Adults aged 18-75 of any gender identity\n* Self-reported non-restorative sleep, as measured by a REST-Q score\n* English-speaking (able to provide consent and complete questionnaires)\n* Capable of taking daytime naps\n* US Citizen\n\nExclusion Criteria:\n\n* Any current or history of neurological disorders or acquired neurological disease (e.g. stroke, traumatic brain injury), including intracranial lesions\n* History of inpatient psychiatric hospitalization\n* History of head trauma resulting in prolonged loss of consciousness; or a history of \\>3 grade I concussions\n* Current history of poorly controlled headaches including intractable or poorly controlled migraines\n\n  • 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.)\n* 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\n* Possible pregnancy or plan to become pregnant in the next 6 months\n* Any metal in the head\n* Any medical devices or implants (i.e. cardiac pacemaker, medication infusion pump, cochlear implant, vagal nerve stimulator)\n* Dental implants\n* Permanent retainers\n* Any hair braid, dreadlocks, hair pieces, or extensions which cannot be taken out before the study sessions\n* Any head coverings or headdress that participant feels uncomfortable removing for the purposes of study sessions\n* Any medication that may alter seizure threshold taken during the study i.e., ADHD stimulants (Adderall, amphetamine); Tricyclic\u002Fatypical 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)\n* Claustrophobia (a fear of small or closed places)\n* Back problems that would prevent lying flat for up to two hours\n* Regular night-shift work (second or third shift)",[75,76],"ADULT","OLDER_ADULT",[78],{"facility":79,"status":8,"city":80,"state":81,"zip":82,"country":83,"contacts":84,"geoPoint":93},"University of Wisconsin - Madison","Madison","Wisconsin","53705","United States",[85,90],{"name":86,"role":87,"phone":88,"email":89},"PowerNap Study Team","CONTACT","608-263-4313","powernap@psychiatry.wisc.edu",{"name":91,"role":92},"Guilio Tononi, MD, PhD","PRINCIPAL_INVESTIGATOR",{"lat":94,"lon":95},43.07305,-89.40123,[97],{"name":86,"role":87,"phone":88,"email":89},[99],{"name":91,"affiliation":13,"role":92},[],[],{"nct_id":4,"conditions":103,"biomarkers":105},[20,104],"Non-restorative sleep",[],{"nct_id":4,"found":15,"summary":107,"prompt_version":117},{"design":108,"status":109,"heading":110,"summary":111,"follow_up":112,"word_count":113,"commitments":114,"compensation":115,"drugs_mentioned":116},"This is an interventional study with a planned enrollment of 25 participants. The phase of the study is not specified.","completed","Power Nap With TES-TI for Non-Restorative Sleep","This study is exploring if a brain stimulation device called Transcranial Electrical Stimulation with Temporal Interference (TES-TI) can improve sleep and reduce mental tiredness during naps. Researchers want to see if TES-TI can increase \"slow waves\" in the brain, which are important for restorative sleep. You might be able to join if you are an adult between 18 and 75 years old, speak English, are a US citizen, and experience non-restorative sleep (meaning you don't feel rested after sleeping). The study will measure changes in your slow waves, sleep quality, and mood over one month to see if the intervention is successful. The current recruitment status is unclear, but the study plans to enroll 25 participants.","Your sleep quality and mood will be measured at Baseline and again at 1 month. Changes in slow waves will also be measured from Baseline to 1 month.",116,"You would attend 2 study visits, each lasting up to 4-5 hours. During these visits, you will wear a high-density electroencephalography (hdEEG) cap and take a nap.","Not stated in the trial record.",[32],"v2"]