Clinical trial NCT06604208: Improvement of Sleep Quality of Insomnia Patients with "Binaural Beats"
Official title: Double-blind, Randomized, Placebo-controlled Trial to Explore the Improvement of Sleep Quality of Insomnia Patients with "Binaural Beats"
Study type: INTERVENTIONAL
Overall status: RECRUITING
Phase: NA
Conditions: Insomnia Chronic
Lead sponsor: Chang Gung Memorial Hospital
Sponsor class: OTHER
First posted: 2024-09-19
Enrollment: 74
Sex: ALL
Minimum age (years): 20
Maximum age (years): 75
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

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:

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

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 difficulty falling asleep, poor sleep quality, and early awakening. Studies have shown that chronic insomnia is closely related to diseases such as hypertension and type 2 diabetes and can lead to impaired daytime functioning and mood disorders. The prevalence of insomnia is high, affecting about 10% of the global population. In Taiwan, the prevalence of chronic insomnia is 11.3%, with higher rates observed in women and the elderly. However, many insomnia patients receive only medication, despite the potential side effects of long-term use of sleeping pills. Therefore, exploring the effectiveness of non-pharmacological treatments for insomnia is crucial. In recent years, various non-invasive and non-pharmacological therapies such as mindfulness therapy, acupressure therapy, and acupuncture therapy have gained attention. Overall, the demand for research and treatment of insomnia is increasing.

Additionally, some emerging therapies such as Schumann wave therapy and binaural beat therapy are being explored in research. The former has been shown to improve sleep quality, while the latter has shown potential for enhancing sleep. Binaural beats play a significant role in sleep medicine. This auditory stimulation involves hearing slightly different frequencies in each ear, influencing the brain through the brainstem and reticular activating system to create a new frequency, thereby improving sleep quality. Research indicates that dynamic binaural beats (DBB) can effectively shorten sleep latency and reduce heart rate variability, helping to enhance sleep quality. Furthermore, the application of binaural beats has expanded to the field of insomnia treatment, aiming to help insomnia patients improve sleep quality and increase safety. These research findings suggest that binaural beats may be a non-invasive, effective, non-pharmacological treatment option for sleep support.

The binaural beat device is a health product that is not classified as a medical device. It functions similar to a music box, providing different frequencies through physiological and psychological induction. This process offers binaural beat information to the Reticular Activating System (RAS) for potential changes in consciousness. The binaural beat frequencies are designed to match the brainwave frequency of light sleep, specifically 3.4 Hz (θ waves), with a base frequency of 440 Hz. The device uses three types of background music-piano music, light music, and string music-as experimental materials.

The binaural beat device offers three modes, allowing users to select different modes based on their comfort and listening preferences. This study requires that the binaural beats are listened to for at least 30 minutes. The device has a built-in app for continuous playback, so users can connect the power and listen throughout the night.

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.

Primary outcomes:
measure: Pittsburgh Sleep Quality Index (PSQI)
timeFrame: baseline, week3, week 7
measure: Actigraphy
timeFrame: baseline, week1-2
Secondary outcomes:
measure: Epworth Sleepiness Scale (ESS)
timeFrame: baseline, week3, week 7
measure: Beck Depression Inventory (BDI)
timeFrame: baseline, week3, week 7
measure: Beck Anxiety Inventory (BAI)
timeFrame: baseline, week3, week 7
measure: Short Form (36) Health Survey (SF-36)
timeFrame: baseline, week3, week 7
measure: Sleep diary
timeFrame: baseline, week1-3, week 7
Other outcomes:
Locations:
city: Taoyuan
country: Taiwan
facility: Chang Gung Memorial Hospital
Study officials:
affiliation: Chang Gung Memorial Hospital
name: Yu-Shu Huang, MD, PhD
role: STUDY_CHAIR
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