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Improvement of Sleep Quality of Insomnia Patients with "Binaural Beats"
Sponsor: Chang Gung Memorial Hospital
Summary
The goal of this clinical trial is to learn if binaural beat works to treat chronic insomnia in adults. It will also learn about the safety of binaural beat. The main questions it aims to answer are: What medical problems do participants have when using binaural beat? Researchers will compare binaural beat to a placebo to see if binaural beat works to treat chronic insomnia. Participants will: Using binaural beat or a placebo every day for 2 weeks Keep a diary and actigraphy of their insomnia symptoms Visit the clinic after 2 weeks testing for checkups and tests
Official title: Double-blind, Randomized, Placebo-controlled Trial to Explore the Improvement of Sleep Quality of Insomnia Patients with "Binaural Beats"
Key Details
Gender
All
Age Range
20 Years - 75 Years
Study Type
INTERVENTIONAL
Enrollment
74
Start Date
2024-12-27
Completion Date
2025-08-31
Last Updated
2025-02-14
Healthy Volunteers
No
Conditions
Interventions
Binaural Beats
The binaural beat device is a health product that is not classified as a medical device. It functions similarly to a music box, providing different frequencies through physiological and psychological induction. This process offers binaural beat information to the Reticular Activating System (RAS) for potential changes in consciousness. The binaural beat frequencies are designed to match the brainwave frequency of light sleep, specifically 3.4 Hz (θ waves), with a base frequency of 440 Hz. The device uses three types of background music-piano music, light music, and string music-as experimental materials. The binaural beat device offers three modes, allowing users to select different modes based on their comfort and listening preferences. This study requires that the binaural beats be listened to for at least 30 minutes. The device has a built-in app for continuous playback, so users can connect the power and listen throughout the night.
Placebo
Placebo
Locations (1)
Chang Gung Memorial Hospital
Taoyuan District, Taiwan, Taiwan