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

NCT06604208 | Recruiting

• 1 other identifier: 202401052B0
• Study Type: interventional
• Target: 74
• Locations: 1 country
• Sites: 1

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

Conditions

Insomnia Chronic

Outcome Measures

Primary Outcomes (2)

• Pittsburgh Sleep Quality Index (PSQI)

  The Pittsburgh Sleep Quality Index (PSQI) is a standardized questionnaire designed to assess sleep quality and patterns over a one-month period. The PSQI has a scoring range from 0 to 21, with higher scores indicating worse sleep quality. The questionnaire is divided into seven components, each addressing different aspects of sleep, such as sleep duration, disturbances, and daytime dysfunction. The sum of these component scores gives the overall PSQI score.

  baseline, week3, week 7

• Actigraphy

  Actigraphy is a non-invasive method used to monitor and assess sleep patterns and circadian rhythms. It involves wearing a small, wristwatch-like device called an actigraph, which measures movement over extended periods, typically one week or longer. By analyzing the data collected, researchers or clinicians can estimate sleep duration, sleep onset, wake times, and periods of restlessness. Actigraphy is particularly useful for studying sleep in naturalistic settings, providing an objective measure of sleep-wake cycles without requiring the individual to stay in a sleep lab. It is often used to assess sleep disorders, such as insomnia or circadian rhythm disturbances, and can be an essential tool for both clinical evaluations and sleep research.

  baseline, week1-2

Secondary Outcomes (5)

• Epworth Sleepiness Scale (ESS)

  baseline, week3, week 7

• Beck Depression Inventory (BDI)

  baseline, week3, week 7

• Beck Anxiety Inventory (BAI)

  baseline, week3, week 7

• Short Form (36) Health Survey (SF-36)

  baseline, week3, week 7

• Sleep diary

  baseline, week1-3, week 7

Study Arms (2)

Binaural Beats

EXPERIMENTAL

Device: Binaural Beats

Placebo

SHAM COMPARATOR

Device: Placebo

Interventions

Binaural Beats DEVICE

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 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 be 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.

Binaural Beats

Placebo DEVICE

Placebo

Placebo

Eligibility Criteria

• Age: 20 Years - 75 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify 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 may not qualify 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, 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.

Sponsors & Collaborators

• Chang Gung Memorial Hospital: lead

Study Sites (1)

Chang Gung Memorial Hospital

Taoyuan District, Taiwan, 333, Taiwan

RECRUITING

Related Publications (7)

• 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 BACKGROUND

• 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 BACKGROUND

• 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 BACKGROUND

• 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 BACKGROUND

• 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 BACKGROUND

• 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 BACKGROUND

• 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 BACKGROUND

MeSH Terms

Conditions

Sleep Initiation and Maintenance Disorders

Condition Hierarchy (Ancestors)

Sleep Disorders, Intrinsic; Dyssomnias; Sleep Wake Disorders; Nervous System Diseases; Mental Disorders

Study Officials

• Yu-Shu Huang, MD, PhD

  Chang Gung Memorial Hospital

  STUDY CHAIR

Central Study Contacts

Yi-Min Fang, MD

CONTACT

+886931776313; butterlion721@gmail.com

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: TRIPLE
• Who Masked: PARTICIPANT, CARE PROVIDER, INVESTIGATOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: August 27, 2024
• First Posted: September 19, 2024
• Study Start: December 27, 2024
• Primary Completion: April 30, 2025
• Study Completion: August 31, 2025
• Last Updated: February 14, 2025

Record last verified: 2024-08

Data Sharing

• IPD Sharing: Will not share

Locations

TW (1)