跳至主要内容
临床试验/NCT05066009
NCT05066009已完成不适用

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

Emory University2 个研究点 分布在 1 个国家目标入组 8 人开始时间: 2021年10月13日最近更新:
适应症

试验速览

阶段
不适用
状态
已完成
入组人数
8
试验地点
2
主要终点
Change in sleep onset latency

研究概览

简要总结

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).

详细描述

Detection of "sleepiness" has for more than four decades relied upon methods that acquire the electroencephalogram (EEG) from multiple surface electrodes applied to the scalp and hardware that amplifies and stores information on a central processing unit (CPU). There are substantial limitations to this methodology beyond the fact that it is time, labor, and cost intensive. Such procedures restrict a subject's freedom of movement and necessitate that patients are monitored by trained staff in an accredited laboratory which levies substantial time and financial burdens upon patients and families. Finally, the test-re-test reliability and utility of testing paradigms reliant solely on an EEG 'signature' to detect statistically meaningful - let alone clinically meaningful - changes is dubious, and has come under increased scrutiny.

This study will assess whether novel wearable technology (NextSense EEGBuds and/or Ellcie Healthy Glasses) are able to detect differences in onset to sleep in patients diagnosed as having one of the central disorders of hypersomnolence (e.g., narcolepsy type 1 or type 2, or idiopathic hypersomnia) while using their prescribed wake promoting medication(s) versus while they are not medicated, and how it's sensitivity compares to differences as detected by the standard MWT. The two study visits will occur within 16 days of one another.

研究设计

研究类型
Interventional
分配方式
Randomized
干预模型
Crossover
主要目的
Device Feasibility
盲法
Single (Investigator)

入排标准

年龄范围
18 Years 至 60 Years(Adult)
性别
All
接受健康志愿者

入选标准

  • Adults ages 18-60 years of age previously diagnosed with narcolepsy type I (NT1), narcolepsy type 2 (NT2), or idiopathic hypersomnia (IH).
  • 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.

排除标准

  • Presence of a diagnosed or suspected co-morbid sleep-related breathing disorder, parasomnia, or other sleep-related movement disorder.
  • Unstable psychiatric disorder (e.g., acute psychosis, acute suicidal ideation or major depressive episode, active substance abuse/dependence).
  • History of malignancy (active or in remission for < 2 years) or active infectious disease at time of screening.
  • Inability to safely tolerate wearing earbuds due to recent injury, skin breakdown, or infection.
  • Uncorrected near visual acuity no worse than 20/
  • Any other condition which may affect the outcome of this study or safety of the participant as determined by the principal investigator.

结局指标

主要结局

Change in sleep onset latency

时间窗: Study visits 1 and 2 (up to 16 days)

Sleep onset latency is the time in minutes it takes to transition from wakefulness to sleep. Within-individual change in the mean onset to sleep will be assessed from the two MWT sessions performed as detected by NextSense EEGBuds.

次要结局

  • Intraclass correlation between measurement methods(Up to 16 days)

研究者

申办方类型
Other
责任方
Principal Investigator
主要研究者

David Rye

Professor

Emory University

研究点 (2)

Loading locations...

相似试验