NCT05743114

Sounds Locked to ElectroEncephalogram Phase For the Acceleration of Sleep Onset Time

Non-Invasive, Non-pharmacologic, Computer Interface Approach to Modulate Electroencephalogram (EEG) Potentials, Alertness and Sleep With Acoustic Stimulation

• Status: Completed
• Phase: N/A
• Study type: Interventional
• Enrollment: 200 (actual)
• Sponsor: Elemind Technologies, Inc. · Industry
• Sex: All
• Age: 21 Years – 55 Years
• Healthy volunteers: Accepted

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.

Conditions

• Sleep
• Sleep Disturbance

Interventions

Type	Name	Description
DEVICE	Elemind Neuromodulation (ENMod)	The ENMod is a headband that measures electroencephalogram (EEG) activity, computes the phase of neural oscillations in real-time, and delivers auditory pulses intended to interact with ongoing neural oscillations.

Timeline

• Start date: 2020-02-02
• Primary completion: 2023-11-15
• Completion: 2024-01-10
• First posted: 2023-02-24
• Last updated: 2024-02-20

Locations

1 site across 1 country: United States