Actively Recruiting

Phase Not Applicable
Age: 20Years - 75Years
All Genders
NCT06604208

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

Led by Chang Gung Memorial Hospital · Updated on 2025-02-14

74

Participants Needed

1

Research Sites

35 weeks

Total Duration

On this page

AI-Summary

What this Trial Is About

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

Official Title

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

Who Can Participate

Age: 20Years - 75Years
All Genders

Eligibility Criteria

Eligible

You may qualify if you...

  • No gender restrictions, aged between 20 and 75 years
  • Diagnosed with insomnia based on DSM-5 criteria: difficulty sleeping at least 3 nights per week
  • Insomnia symptoms lasting at least 3 months
  • Signed informed consent form
Not Eligible

You will not qualify if you...

  • Unable to complete consent, testing, or follow-up visits
  • Severe physical illnesses or post-surgical conditions such as heart disease or metabolic disorders
  • Severe psychiatric disorders like schizophrenia, major depressive disorder, severe anxiety, bipolar disorder, dementia, or substance use disorders
  • Severe neurological conditions including stroke or epilepsy
  • Other severe sleep disorders such as severe sleep apnea
  • Unable to maintain stable medication dosage during the trial
  • Deemed unsuitable by the principal investigator
  • Unable to follow sleep hygiene practices or refrain from using electronic devices before bedtime

AI-Screening

AI-Powered Screening

Complete this quick 3-step screening to check your eligibility

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Trial Site Locations

Total: 1 location

1

Chang Gung Memorial Hospital

Taoyuan, Taiwan, Taiwan, 333

Actively Recruiting

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Research Team

Y

Yi-Min Fang, MD

CONTACT

How is the study designed?

Study Type

INTERVENTIONAL

Masking

TRIPLE

Allocation

RANDOMIZED

Model

PARALLEL

Primary Purpose

TREATMENT

Number of Arms

2

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