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

Recruiting now · Not applicable · Has a placebo group

Conditions studied: Insomnia Chronic

In brief

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

Key facts

Study ID

NCT06604208

Run by

Chang Gung Memorial Hospital

People needed

74

Starts

2024-12-27

Expected to finish

2025-08-31

Last updated by the study team

2025-02-14

Who can join

Age: 20 and older, up to 75. Sex: any. Healthy volunteers: not accepted.

You may qualify if…

• 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):
• Difficulty sleeping and insomnia occurring at least 3 nights per week.
• Insomnia and sleep difficulties persisting for at least 3 months.
• The participant has signed the informed consent form.

You may not qualify if…

• 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 it is running

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

Full record on ClinicalTrials.gov

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