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Search / Trial NCT06604208

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

Launched by CHANG GUNG MEMORIAL HOSPITAL · Sep 17, 2024

Trial Information

Current as of June 18, 2025

Recruiting

Keywords

ClinConnect Summary

This clinical trial is studying a method called "binaural beats" to see if it can help adults with chronic insomnia, which is difficulty sleeping that happens most nights over a period of three months or more. The researchers want to find out if binaural beats can improve sleep quality compared to a placebo, which is a treatment that has no active ingredients. They will also monitor any medical problems that participants might experience while using binaural beats.

If you're between the ages of 20 and 75 and have been struggling with insomnia, you might be eligible to participate. During the trial, you’ll either listen to binaural beats or a placebo for two weeks. You’ll keep a diary of your sleep experiences and wear a device to track your sleep patterns. After two weeks, you’ll return to the clinic for a checkup. It’s important to note that individuals with certain severe health conditions or those unable to follow the study's requirements won’t be able to join. This trial is currently recruiting participants, so if you're interested, it could be a great opportunity to explore a new way to improve your sleep.

Gender

ALL

Eligibility criteria

  • Inclusion Criteria:
  • Gender: No restrictions, Age: Between 20 and 75 years.
  • * Meets the criteria for insomnia as defined by the Diagnostic and Statistical Manual of Mental Disorders, Fifth Edition (DSM-5):
  • 1. Difficulty sleeping and insomnia occurring at least 3 nights per week.
  • 2. Insomnia and sleep difficulties persisting for at least 3 months.
  • The participant has signed the informed consent form.
  • Exclusion Criteria:
  • Individuals who are unable to complete the consent form, undergo testing, and attend regular follow-up visits as required by the study.
  • Individuals with severe physical illnesses or post-surgical conditions, such as heart disease or metabolic disorders.
  • Individuals with severe psychiatric disorders, including schizophrenia, major depressive disorder, severe anxiety disorder, bipolar disorder, dementia, or substance use disorders; or severe neurological conditions, such as stroke or epilepsy.
  • Individuals with other severe sleep disorders, such as severe sleep apnea.
  • Individuals who are unable to maintain a stable medication dosage during the trial period, particularly with ongoing treatments.
  • Patients deemed unsuitable for participation in the trial by the principal investigator.
  • Patients who are unable to adhere to sleep hygiene practices or who cannot refrain from using electronic devices before bedtime.

About Chang Gung Memorial Hospital

Chang Gung Memorial Hospital, one of the largest healthcare organizations in Taiwan, is renowned for its commitment to advancing medical research and improving patient care. As a clinical trial sponsor, the hospital leverages its extensive clinical expertise and state-of-the-art facilities to conduct innovative research across various medical disciplines. With a focus on collaboration and ethical practices, Chang Gung Memorial Hospital aims to contribute to the global body of medical knowledge through rigorous clinical trials that enhance treatment options and improve health outcomes for patients.

Locations

Taoyuan, , Taiwan

Patients applied

0 patients applied

Trial Officials

Yu-Shu Huang, MD, PhD

Study Chair

Chang Gung Memorial Hospital

Timeline

First submit

Trial launched

Trial updated

Estimated completion

Not reported