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NCT04445129 · ClinicalTrials.gov registry record
Wake and Sleep State Transitions on a Portable Electroencephalogram (EEG) Device in Narcolepsy Type 1 (NT1) and Healthy Participants
A clinical trial, sponsored by Takeda.
- Completed
- Registry status
- 45
- Enrollment target
NCT04445129: Completed study, sponsored by Takeda.
NCT04445129 is a clinical trial that has completed, run by Takeda. The registered enrollment target is 45 participants. According to ClinicalTrials.gov, the official US trial registry.
The verdict
NCT04445129 has completed, sponsored by Takeda.
- COMPLETED
- Registry status
- 45 participants
- Enrollment target
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.
Primary Outcome
The concordance between EEG signals obtained from the portable EEG device with nPSG over 2 inpatient night stays will be assessed using data obtained during the inpatient setting from nPSG and a portable EEG device. Scoring of sleep stages occur in 30-seconds epoch based on American Academy of Sleep Medicine (AASM) scoring rules. The output from the nPSG and the portable EEG device will be hand scored for each participant, with the rater assigning 1 of 5 sleep/wake stages to each 30 second epoch
Interventions
- DEVICE Portable EEG Device
- DEVICE Portable ECG Device
- DEVICE Accelerometry
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 45 participants |
| Start Date | 2020-08-03 |
| Est. Completion | 2021-05-04 |
What the finished NCT04445129 record still lists
NCT04445129 is an observational study that tracks outcomes without assigning an intervention. The registry caps enrollment at 45 participants, a relatively small participant target.
The record links to 0 conditions, and to 3 interventions - of which Portable EEG Device is the first listed.
NCT04445129 does not publish any study locations in the registry export this page uses.
Frequently Asked Questions
What is clinical trial NCT04445129 about?
NCT04445129 is a clinical study titled "Wake and Sleep State Transitions on a Portable Electroencephalogram (EEG) Device in Narcolepsy Type 1 (NT1) and Healthy Participants". 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-ho...
What is the current status of trial NCT04445129?
This trial is currently completed. The enrollment target is 45 participants. The study started on 2020-08-03. Estimated completion is 2021-05-04.
What interventions are being tested in trial NCT04445129?
The interventions under investigation include: Portable EEG Device (DEVICE), Portable ECG Device (DEVICE), Accelerometry (DEVICE).
Who is sponsoring clinical trial NCT04445129?
This trial is sponsored by Takeda, which has 408 total clinical trials registered on ClinicalTrials.gov.
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