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"

Overview

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.

Interventions

• Device Binaural Beats
  The binaural beat device is a health product that is not classified as a medical device. It functions similarly 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 de
• Device Placebo
  Placebo

Primary outcome measures

• Pittsburgh Sleep Quality Index (PSQI) [Time frame: baseline, week3, week 7]
• Actigraphy [Time frame: baseline, week1-2]

Secondary outcome measures (5)

• Epworth Sleepiness Scale (ESS) [Time frame: baseline, week3, week 7]
• Beck Depression Inventory (BDI) [Time frame: baseline, week3, week 7]
• Beck Anxiety Inventory (BAI) [Time frame: baseline, week3, week 7]
• Short Form (36) Health Survey (SF-36) [Time frame: baseline, week3, week 7]
• Sleep diary [Time frame: baseline, week1-3, week 7]

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):

• 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 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.

Criteria are shown verbatim from the registry (in English). Final eligibility is always assessed by the study center.

Healthy volunteers: No

Study design

Allocation

Randomized

Model

Parallel assignment

Masking

Triple blind

Primary purpose

Treatment

Study locations

Taiwan · 1 center

• Chang Gung Memorial Hospital — Taoyuan

Publications

• Agarwal SD, Landon BE. Patterns in Outpatient Benzodiazepine Prescribing in the United States. JAMA Netw Open. 2019 Jan 4;2(1):e187399. doi: 10.1001/jamanetworkopen.2018.7399. PMID 30681713
• Belisheva NK, Popov AN, Petukhova NV, Pavlova LP, Osipov KS, Tkachenko SE, Varanova TI. [Qualitative and quantitative assessment of exposure to geomagnetic field variations on the functional status of the human brain]. Biofizika. 1995 Sep-Oct;40(5):1005-12. Russian. PMID 8555283
• Buscemi N, Vandermeer B, Friesen C, Bialy L, Tubman M, Ospina M, Klassen TP, Witmans M. The efficacy and safety of drug treatments for chronic insomnia in adults: a meta-analysis of RCTs. J Gen Intern Med. 2007 Sep;22(9):1335-50. doi: 10.1007/s11606-007-0251-z. Epub 2007 Jul 10. PMID 17619935
• Colzato LS, Barone H, Sellaro R, Hommel B. More attentional focusing through binaural beats: evidence from the global-local task. Psychol Res. 2017 Jan;81(1):271-277. doi: 10.1007/s00426-015-0727-0. Epub 2015 Nov 26. PMID 26612201
• Galvez G, Recuero M, Canuet L, Del-Pozo F. Short-Term Effects of Binaural Beats on EEG Power, Functional Connectivity, Cognition, Gait and Anxiety in Parkinson's Disease. Int J Neural Syst. 2018 Jun;28(5):1750055. doi: 10.1142/S0129065717500551. Epub 2017 Nov 13. PMID 29297265
• Wahbeh H, Calabrese C, Zwickey H. Binaural beat technology in humans: a pilot study to assess psychologic and physiologic effects. J Altern Complement Med. 2007 Jan-Feb;13(1):25-32. doi: 10.1089/acm.2006.6196. PMID 17309374
• Zampi DD. Efficacy of Theta Binaural Beats for the Treatment of Chronic Pain. Altern Ther Health Med. 2016 Jan-Feb;22(1):32-8. PMID 26773319

Identifiers

NCT: NCT06604208 · 202401052B0

Primary sources (government registries)

• ClinicalTrials.gov (US NIH)

View this study on ClinicalTrials.gov ↗