COMPLETED

Sleep/Wake State Assessment with Non-invasive Earbuds

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

This study is a within subject's assessment of whether a novel wearable technology, NextSense electroencephalography earbuds (EEGBuds), is able to detect differences in onset to sleep from wake versus in-laboratory, gold-standard electroencephalography (EEG) utilized as part of a standard four trial Maintenance of Wakefulness Test (MWT) at medicated baseline versus free of prescribed medications for promoting wake (random order).

Official Title

Feasibility of Detecting Within Subject Differences in Sleepiness with NextSense Earbud Electroencephalography Devices

Quick Facts

Study Start:2021-10-13
Study Completion:2023-10-27
Study Type:Not specified
Phase:Not Applicable
Enrollment:Not specified
Status:COMPLETED

Study ID

NCT05066009

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 60 Years
Sexes Eligible for Study:ALL
Accepts Healthy Volunteers:No
Standard Ages:ADULT
Inclusion CriteriaExclusion Criteria
  1. * Adults ages 18-60 years of age previously diagnosed with narcolepsy type I (NT1), narcolepsy type 2 (NT2), or idiopathic hypersomnia (IH).
  2. * Requiring daily wake promoting medication(s) continuously for 3 months for diagnosed NT1, NT2 or IH with symptomatic improvement on treatment documented by standard subjective or objective tools.
  1. * Presence of a diagnosed or suspected co-morbid sleep-related breathing disorder, parasomnia, or other sleep-related movement disorder.
  2. * Unstable psychiatric disorder (e.g., acute psychosis, acute suicidal ideation or major depressive episode, active substance abuse/dependence).
  3. * History of malignancy (active or in remission for \< 2 years) or active infectious disease at time of screening.
  4. * Inability to safely tolerate wearing earbuds due to recent injury, skin breakdown, or infection.
  5. * Uncorrected near visual acuity no worse than 20/50.
  6. * Any other condition which may affect the outcome of this study or safety of the participant as determined by the principal investigator.

Contacts and Locations

Principal Investigator

David Rye, MD, PhD
PRINCIPAL_INVESTIGATOR
Emory University

Study Locations (Sites)

Emory Sleep Center
Atlanta, Georgia, 30329
United States

Collaborators and Investigators

Sponsor: Emory University

  • David Rye, MD, PhD, PRINCIPAL_INVESTIGATOR, Emory University

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 Date2021-10-13
Study Completion Date2023-10-27

Study Record Updates

Study Start Date2021-10-13
Study Completion Date2023-10-27

Terms related to this study

Keywords Provided by Researchers

  • Narcolepsy type 1
  • Narcolepsy type 2
  • Idiopathic hypersomnia

Additional Relevant MeSH Terms

  • Hypersomnolence