NCT04445129

Wake and Sleep State Transitions on a Portable Electroencephalogram (EEG) Device in Narcolepsy Type 1 (NT1) and Healthy Participants

A Study to Assess the Frequency and Characteristics of Wake and Sleep State Transitions Over Multiple Nights in Subjects With Narcolepsy Type 1 Compared With Healthy Subjects Using a Portable Electroencephalogram Device

• Status: Completed
• Phase: —
• Study type: Observational
• Enrollment: 45 (actual)
• Sponsor: Takeda · Industry
• Sex: All
• Age: 16 Years – 60 Years
• Healthy volunteers: Accepted

Summary

The purpose of this study is to determine whether portable devices can provide measurements at home similar to those taken in the clinic, in particular in participant with NT1, and to investigate night-to-night changes in sleep patterns using these devices at home. This study may enable future at-home studies and ultimately lead to a decreased burden on the people who need these measurements.

Detailed description

This is a non-drug study including participants with NT1 and healthy participants using devices designed for at-home assessments. The study will assess whether a portable EEG device provides an EEG signal comparable to inpatient nPSG. The frequency and characteristics of wake and sleep patterns and transitions over multiple nights will also be characterized. Participants with NT1 who will complete the study TAK-994-1501 (NCT04096560) will be eligible to enter the current study following the appropriate washout period (60 days). The study will enroll approximately 32 participants (16 participants with NT1 and 16 healthy participants). Participants will be enrolled in the 2 groups: * NT1 Participants * Healthy Participants This multi-center trial will be conducted in the United States. The overall time to participate in this study is approximately 8 days. The follow-up visit will occur on Day 10 and during this debrief, participants will answer a questionnaire on user experience (device comfort) for the wearable devices.

Conditions

• Healthy Volunteers
• Narcolepsy Type 1

Interventions

Type	Name	Description
DEVICE	Portable EEG Device	Portable EEG device is lightweight and designed for nighttime wear.
DEVICE	Portable ECG Device	Portable ECG device is waterproof and will be adhered to the chest of the participant.
DEVICE	Accelerometry	Portable accelerometry device is noninvasive and will capture data on participant activity level, including intensity of movement, rest, and sleep.

Timeline

• Start date: 2020-08-03
• Primary completion: 2021-04-29
• Completion: 2021-05-04
• First posted: 2020-06-24
• Last updated: 2021-05-07

Locations

13 sites across 1 country: United States

Regulatory

• FDA-regulated device study