AUTHOR=Gantt Melisa A. 

TITLE=Study protocol to support the development of an all-night binaural beat frequency audio program to entrain sleep

JOURNAL=Frontiers in Neurology

VOLUME=Volume 14 - 2023

YEAR=2023

URL=https://www.frontiersin.org/journals/neurology/articles/10.3389/fneur.2023.1024726

DOI=10.3389/fneur.2023.1024726

ISSN=1664-2295

ABSTRACT=Background: Given that the stages of sleep have specific brainwave patterns, it may be feasible to manipulate brainwaves to induce sleep to improve better sleep quality. Binaural beat frequencies (BBFs) are an auditory-neurologic technique that uses auditory tones via headphones to manipulate brainwaves in turn affecting the listener’s state of consciousness. However, BBFs are often sold in only one frequency which may not allow the listener to transition through the phases of sleep.  This study is Phase 2 of a four-phase feasibility study to assess if systematically sequencing a variety of BBFs can improve sleep efficiency.

Method: This protocol uses a two cohort unblinded and double-blinded, randomized, pre- and post-intervention methods and crossover matched group design. In Cohort 1, a sample of 106 participants with poor sleep quality will be randomized into two groups. All participants will start with one week of no intervention. Group 1 will use theta/delta BBF for two weeks followed by one week of no intervention followed by music for two weeks. Group 2 will do the reverse. In Cohort 2, 62 participants will be blinded and randomized into two groups. Group 3 will use music for two weeks followed by a one-week break followed by music embedded with theta/delta BBF for two weeks. Group 4 will do the reverse. Using Cohort 1 music only as a control, data will be collected using sleep actigraphy, sleep quality questionnaires, and sleep diaries with a crossover and match group analysis between cohorts to compare the effect of no intervention vs. music vs. BBF only vs. music with BBF on sleep quality. 

Discussion: Phase 1 concluded that theta BBF was able to decrease stress to help induce sleep. Phase 2 will assess if theta and delta BBFs, with breaks to allow for REM, will be able to sustain sleep to improve sleep efficiency.  The data from Phases  1 and 2 will provide information to help construct an all-night audio program with the appropriate BBF and timing to trigger the correct sleep stage for better sleep efficiency.  If this concept is feasible, it could be beneficial for many sleep disorders.