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New treatment option for Insomnia Chronic
Official title Improvement of Sleep Quality of Insomnia Patients with "Binaural Beats"
ClinicalTrials.gov ID: NCT06604208
What this study is testing
- What it's testing
- 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.
- You might receive a placebo (an inactive treatment) instead of the study drug.
A plain-language read of the study's public ClinicalTrials.gov listing. The study team confirms the details.
Who can take part
Ages 20 to 75
You may be able to join 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 likely can't join 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...
- 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.
See the full eligibility 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):
- 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.
- 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...
- 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.
The study team makes the final eligibility decision.
Where it's taking place
- Taoyuan, Taiwan, Taiwan
Questions & answers
Do participants get paid in this trial?
This listing doesn't specify compensation. Many trials still reimburse travel or offer a stipend, so it's worth asking the study team when you connect.
Is it free to join, and do I need insurance?
Searching and applying through BridgeMD is free. In clinical trials the study-related treatment and visits are generally provided at no cost to you. You usually don't need insurance to take part - confirm specifics with the study team.
How long does this study last?
The listing doesn't state an exact length. The study team walks you through the schedule and number of visits before you decide to enroll.
Who can join this trial?
This study is enrolling all sexes, 20 years to 75 years. The study team makes the final eligibility decision.
Where is this trial taking place?
Study sites include Taoyuan, Taiwan, Taiwan. Enter your location above to see the nearest site and check your eligibility.
Explore other conditions
BridgeMD is an information and trial-matching tool - not medical advice, and not the study sponsor. Details come from ClinicalTrials.gov; the study team decides eligibility.