RECRUITING

Rapid Eye Movement Restoration and Enhancement for Sleep-deprived Trauma-adaptation

Study Overview

This clinical trial focuses on testing the efficacy of different digital interventions to promote re-engagement in cancer-related long-term follow-up care for adolescent and young adult (AYA) survivors of childhood cancer.

Description

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.

Official Title

Rapid Eye Movement Restoration and Enhancement for Sleep-deprived Trauma-adaptation

Quick Facts

Study Start:2024-07-10
Study Completion:2026-06
Study Type:Not specified
Phase:Not Applicable
Enrollment:Not specified
Status:RECRUITING

Study ID

NCT06547086

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Ages Eligible for Study:18 Years to 50 Years
Sexes Eligible for Study:ALL
Accepts Healthy Volunteers:Yes
Standard Ages:ADULT
Inclusion CriteriaExclusion Criteria
  1. * Adults aged 18-50 years
  2. * Medically healthy
  3. * English-speaking (able to provide consent and complete questionnaires)
  4. * Citizen or holding permanent resident status
  5. * Regular napper (1 or more naps per week)
  1. * Any current or past history of neurological disorders or acquired neurological disease (e.g. stroke, traumatic brain injury), including intracranial lesions
  2. * History or head trauma resulting in prolonged loss of consciousness; or a history of \>3 grade 1 concussions
  3. * Current history of poorly controlled headaches including intractable or poorly controlled migraines
  4. * 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)
  5. * 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
  6. * Possible pregnancy or plan to become pregnant in the next 6 months
  7. * Any metal in the body
  8. * Any medical devices or implants (i.e. cardiac pacemaker, medication infusion pump, cochlear implant, vagal nerve stimulator) unless otherwise approved by the responsible MD
  9. * Dental implants containing metal
  10. * 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)
  11. * Claustrophobia (a fear of small or closed places)
  12. * Back problems that would prevent lying flat for up to two hours
  13. * Regular night-shift work (second or third shift)

Contacts and Locations

Study Contact

Stephanie G Jones
CONTACT
608-263-3447
sgjones2@wisc.edu

Principal Investigator

Giulio Tononi, PhD
PRINCIPAL_INVESTIGATOR
University of Wisconsin, Madison

Study Locations (Sites)

University of Wisconsin
Madison, Wisconsin, 53719
United States

Collaborators and Investigators

Sponsor: University of Wisconsin, Madison

  • Giulio Tononi, PhD, PRINCIPAL_INVESTIGATOR, University of Wisconsin, Madison

Study Record Dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Registration Dates

Study Start Date2024-07-10
Study Completion Date2026-06

Study Record Updates

Study Start Date2024-07-10
Study Completion Date2026-06

Terms related to this study

Keywords Provided by Researchers

  • Regular nap taker

Additional Relevant MeSH Terms

  • Healthy Volunteers