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NCT04461769 · ClinicalTrials.gov registry record · Early Phase 1
Electrical Synchronization of Slow Oscillations to Enhance Deep Sleep
A Early Phase 1 study of Sleep and Sleep Hygiene, sponsored by Brain Electrophysiology Laboratory Company.
- Completed
- Registry status
- Early Phase 1
- Development phase
- 13
- Enrollment target
- 1
- Study location
NCT04461769: Completed Early Phase 1 study of Sleep and Sleep Hygiene, sponsored by Brain Electrophysiology Laboratory Company.
NCT04461769 is a Early Phase 1 study of Sleep and Sleep Hygiene that has completed, run by Brain Electrophysiology Laboratory Company. The registered enrollment target is 13 participants, below the 4,166-participant average among 151 other Sleep trials with a reported enrollment target (100% lower). The trial reports 1 study location across 1 state. According to ClinicalTrials.gov, the official US trial registry.
The verdict
NCT04461769, a Early Phase 1 study of Sleep and Sleep Hygiene, has completed, sponsored by Brain Electrophysiology Laboratory Company.
- COMPLETED
- Registry status
- Early Phase 1
- Development phase
- 13 participants
- Enrollment target
- 1
- Study location
Study Summary
This study applied slowly oscillating (0.5 hz) transcranial electrical stimulation (TES; frontopolar and lateral frontal electrodes versus mastoid and occipital electrode returns) to synchronize the endogenous slow oscillations (SOs) of deep sleep (N3 or stage 3 Non-REM). A double-blind placebo control provided no stimulation. The primary endpoint was duration of N3 sleep during the night. Thirteen normal adults completed the study (before the study was terminated because of COVID-19), and usable data were obtained from ten. The synchronizing stimulation resulted in significantly longer N3 sleep compared to placebo.
Primary Outcome
Duration in minutes of N3 sleep
Conditions Studied
Interventions
- DEVICE Transcranial Electrical Stimulation
Study Locations (1)
Oregon
- Brain Electrophysiology Laboratory Company - Eugene
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 13 participants |
| Start Date | 2019-09-01 |
| Est. Completion | 2020-05-30 |
| Phase | Early Phase 1 |
What the finished NCT04461769 record still lists
NCT04461769 is an interventional study that assigns participants to a tested intervention. The registry caps enrollment at 13 participants, a relatively small participant target, below the 4,166-participant average among 151 other Sleep trials with a reported enrollment target (100% lower).
The record links to 2 conditions, with Sleep appearing as the primary indexed condition, and to 1 intervention - of which Transcranial Electrical Stimulation is the first listed.
NCT04461769 reports a single indexed study location in Oregon.
Frequently Asked Questions
What is clinical trial NCT04461769 about?
NCT04461769 is a clinical study titled "Electrical Synchronization of Slow Oscillations to Enhance Deep Sleep". This study applied slowly oscillating (0.5 hz) transcranial electrical stimulation (TES; frontopolar and lateral frontal electrodes versus mastoid and occipital electrode returns) to synchronize the endogenous slow oscillations (SOs) of deep sleep (N3 or stage 3 Non-REM). A double-blind placebo cont...
What is the current status of trial NCT04461769?
This trial is currently completed. It is a Early Phase 1 study. The enrollment target is 13 participants. The study started on 2019-09-01. Estimated completion is 2020-05-30.
What conditions does trial NCT04461769 study?
This clinical trial studies the following conditions: Sleep, Sleep Hygiene.
What interventions are being tested in trial NCT04461769?
The interventions under investigation include: Transcranial Electrical Stimulation (DEVICE).
Who is sponsoring clinical trial NCT04461769?
This trial is sponsored by Brain Electrophysiology Laboratory Company, which has 2 total clinical trials registered on ClinicalTrials.gov.
Where is trial NCT04461769 being conducted?
This trial has 1 study location across Oregon. Contact the study sites directly through ClinicalTrials.gov for enrollment availability.
Learn More About Clinical Trials
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Where NCT04461769's enrollment target sits among peer trials
13 146th of 151 higher than 5 of 151 other Sleep trials
participants (enrollment target), bucketed by value
Each bar is a band; taller bars hold more other Sleep trials. The dashed line + filled bar mark this entry. Hover or tap any bar for its full count and share, and where it sits relative to this entry.
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