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

NCT06604208 · Status: RECRUITING · Phase: NA · Type: INTERVENTIONAL · Enrollment: 74

Last updated 2025-02-14

No results posted yet for this study

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

Conditions

  • Insomnia Chronic

Interventions

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

Sponsors & Collaborators

  • Chang Gung Memorial Hospital

    lead OTHER

Principal Investigators

  • Yu-Shu Huang, MD, PhD · Chang Gung Memorial Hospital

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
TRIPLE
Model
PARALLEL

Eligibility

Min Age
20 Years
Max Age
75 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2024-12-27
Primary Completion
2025-04-30
Completion
2025-08-31

Countries

  • Taiwan

Study Locations

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Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT06604208 on ClinicalTrials.gov