NCT06604208

Improvement of Sleep Quality of Insomnia Patients with "Binaural Beats"

Double-blind, Randomized, Placebo-controlled Trial to Explore the Improvement of Sleep Quality of Insomnia Patients with "Binaural Beats"

• Status: Recruiting
• Phase: N/A
• Study type: Interventional
• Enrollment: 74 (estimated)
• Sponsor: Chang Gung Memorial Hospital · Academic / Other
• Sex: All
• Age: 20 Years – 75 Years
• Healthy volunteers: Not accepted

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

Detailed description

As the pace of society accelerates, people are under increasing mental stress, which can lead to emotional instability and even insomnia. Insomnia is a common sleep disorder characterized by difficulty falling asleep, poor sleep quality, and early awakening. Studies have shown that chronic insomnia is closely related to diseases such as hypertension and type 2 diabetes and can lead to impaired daytime functioning and mood disorders. The prevalence of insomnia is high, affecting about 10% of the global population. In Taiwan, the prevalence of chronic insomnia is 11.3%, with higher rates observed in women and the elderly. However, many insomnia patients receive only medication, despite the potential side effects of long-term use of sleeping pills. Therefore, exploring the effectiveness of non-pharmacological treatments for insomnia is crucial. In recent years, various non-invasive and non-pharmacological therapies such as mindfulness therapy, acupressure therapy, and acupuncture therapy have gained attention. Overall, the demand for research and treatment of insomnia is increasing. Additionally, some emerging therapies such as Schumann wave therapy and binaural beat therapy are being explored in research. The former has been shown to improve sleep quality, while the latter has shown potential for enhancing sleep. Binaural beats play a significant role in sleep medicine. This auditory stimulation involves hearing slightly different frequencies in each ear, influencing the brain through the brainstem and reticular activating system to create a new frequency, thereby improving sleep quality. Research indicates that dynamic binaural beats (DBB) can effectively shorten sleep latency and reduce heart rate variability, helping to enhance sleep quality. Furthermore, the application of binaural beats has expanded to the field of insomnia treatment, aiming to help insomnia patients improve sleep quality and increase safety. These research findings suggest that binaural beats may be a non-invasive, effective, non-pharmacological treatment option for sleep support. The binaural beat device is a health product that is not classified as a medical device. It functions similar 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 are 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.

Conditions

• Insomnia Chronic

Interventions

Type	Name	Description
DEVICE	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.
DEVICE	Placebo	Placebo

Timeline

• Start date: 2024-12-27
• Primary completion: 2025-04-30
• Completion: 2025-08-31
• First posted: 2024-09-19
• Last updated: 2025-02-14

Locations

1 site across 1 country: Taiwan