Status:
RECRUITING
Improvement of Sleep Quality of Insomnia Patients with "Binaural Beats"
Lead Sponsor:
Chang Gung Memorial Hospital
Conditions:
Insomnia Chronic
Eligibility:
All Genders
20-75 years
Phase:
NA
Brief 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: ...
Detailed Description
As the pace of society accelerates, people are under increasing mental stress, which can lead to emotional instability and even insomnia. Insomnia is a common sleep disorder characterized by difficult...
Eligibility Criteria
Inclusion
- 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.
Exclusion
- 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.
Key Trial Info
Start Date :
December 27 2024
Trial Type :
INTERVENTIONAL
Allocation :
ESTIMATED
End Date :
August 31 2025
Estimated Enrollment :
74 Patients enrolled
Trial Details
Trial ID
NCT06604208
Start Date
December 27 2024
End Date
August 31 2025
Last Update
February 14 2025
Active Locations (1)
Enter a location and click search to find clinical trials sorted by distance.
1
Chang Gung Memorial Hospital
Taoyuan District, Taiwan, Taiwan, 333