![]() ![]() 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. ![]() music with BBF on sleep quality.ĭiscussion: Phase 1 concluded that theta BBF was able to decrease stress to help induce sleep. 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. Group 3 will use music for 2 weeks followed by a 1-week break followed by music embedded with theta/delta BBF for 2 weeks. ![]() In Cohort 2, 62 participants will be blinded and randomized into two groups. Group 1 will use theta/delta BBF for 2 weeks followed by 1 week of no intervention followed by music for 2 weeks. All participants will start with 1 week of no intervention. In Cohort 1, a sample of 106 participants with poor sleep quality will be randomized into two groups. Methods: This protocol uses a two cohort unblinded and double-blinded, randomized, pre- and post-intervention methods and crossover matched group design. This study is Phase 2 of a four-phase feasibility study to assess if systematically sequencing a variety of BBFs can improve sleep efficiency. However, BBFs are often sold in only one frequency which may not allow the listener to transition through the phases of sleep. Binaural beat frequencies (BBFs) are an auditory-neurologic technique that uses auditory tones via headphones to manipulate brainwave activity in turn affecting the listener's state of consciousness. Gantt Clinical Research Institute LLC, Orlando, FL, United Statesīackground: Given that the stages of sleep have specific brainwave patterns, it may be feasible to manipulate brainwaves to induce stages of sleep to improve better sleep quality. ![]()
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