Ignite Creation Date:
2024-05-06 @ 6:41 PM
Last Modification Date:
2024-10-26 @ 2:52 PM
Study NCT ID:
NCT05743114
Status:
COMPLETED
Last Update Posted:
2024-02-20
First Post:
2023-02-06
Brief Title:
Sounds Locked to ElectroEncephalogram Phase For the Acceleration of Sleep Onset Time
Sponsor:
Elemind Technologies Inc
Organization:
Elemind Technologies Inc
Study Overview
Official Title:
Non-Invasive Non-pharmacologic Computer Interface Approach to Modulate Electroencephalogram EEG Potentials Alertness and Sleep With Acoustic Stimulation
Status:
COMPLETED
Status Verified Date:
2024-02
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
Not Stopped
Has Expanded Access:
False
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
SLEEPFAST
Brief Summary:
This study seeks to test whether auditory stimulation delivered at specific phases of the alpha oscillation as measured by electroencephalogram can accelerate sleep onset
Detailed Description:
In healthy sleepers cortical alpha oscillations are present during the transition from wakefulness to sleep and dissipate at sleep onset For individuals with insomnia alpha power is elevated during the wake-sleep transition and can persist throughout the night This study tests whether a wearable device that delivers auditory stimulation phase-locked to alpha oscillations can accelerate sleep onset in healthy adults who report difficulties falling and staying asleep The device is a prototype of the Elemind Neuromodulation system ENMod The ENMod is a wireless headband that measures brain signals computes the phase of neural oscillations in specific frequency bands and delivers audible pink noise pulses at specific times relative to the instantaneous phase of neural oscillations In this study we ask participants to wear the ENMod headband at home while going to sleep The device is programmed to record EEG activity and during the transition from wakefulness to sleep deliver phase-locked sounds that are intended to interact with the participants neural activity and accelerate sleep onset
Study Oversight
Has Oversight DMC:
None
Is a FDA Regulated Drug?:
False
Is a FDA Regulated Device?:
False
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
None
Is an FDA AA801 Violation?:
None