Using binaural beats to improve sleep quality in insomnia patients

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

This study tests whether listening to binaural beats can help adults with chronic insomnia sleep better compared to a placebo.

Quick facts

• Phase: Not applicable
• Study type: Interventional
• Enrollment: 74 (estimated)
• Ages: 20 Years to 75 Years
• Sex: All
• Sponsor: Chang Gung Memorial Hospital (Academic / other)
• Locations: 1 site (Taoyuan, Taiwan)
• Trial ID: NCT06604208 on ClinicalTrials.gov

What this trial studies

This clinical trial aims to evaluate the effectiveness of binaural beats as a treatment for chronic insomnia in adults. Participants will use binaural beats or a placebo daily for two weeks while keeping a diary and undergoing actigraphy to monitor their insomnia symptoms. The study will also assess the safety of binaural beats and compare the results with a placebo group. Follow-up visits will occur after the two-week testing period to conduct checkups and tests.

Who should consider this trial

Good fit: Ideal candidates for this study are adults aged 20 to 75 who meet the DSM-5 criteria for chronic insomnia.

Not a fit: Patients with severe physical illnesses, psychiatric disorders, or other severe sleep disorders may not benefit from this study.

Why it matters

Potential benefit: If successful, this treatment could provide a non-pharmacological option for improving sleep quality in patients with chronic insomnia.

How similar studies have performed: While binaural beats are an emerging therapy, similar non-pharmacological approaches have shown promise in improving sleep quality, indicating potential for success.

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.

Where this trial is running

Taoyuan, Taiwan

• Chang Gung Memorial Hospital — Taoyuan, Taiwan, Taiwan (Recruiting)

Study contacts

• Study coordinator: Yi-Min Fang, MD

Conditions Insomnia Chronic