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

NCT04445129 · Status: COMPLETED · Type: OBSERVATIONAL · Enrollment: 45

Last updated 2021-05-07

No results posted yet for this study

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.

Conditions

Interventions

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.

Sponsors & Collaborators

  • Takeda Development Center Americas, Inc.

    collaborator INDUSTRY

  • Takeda

    lead INDUSTRY

Principal Investigators

  • Medical Director · Takeda Development Center Americas, Inc.

Eligibility

Min Age
16 Years
Max Age
60 Years
Sex
ALL
Healthy Volunteers
Yes

Timeline & Regulatory

Start
2020-08-03
Primary Completion
2021-04-29
Completion
2021-05-04
FDA Device
Yes

Countries

  • United States

Study Locations

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Entities

Diseases
Companies

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT04445129 on ClinicalTrials.gov