Ignite Creation Date:
2024-10-26 @ 3:40 PM
Last Modification Date:
2024-10-26 @ 3:40 PM
Study NCT ID:
NCT06604208
Status:
NOT_YET_RECRUITING
Last Update Posted:
None
First Post:
2024-08-27
Brief Title:
Improvement of Sleep Quality of Insomnia Patients With Binaural Beats
Sponsor:
None
Organization:
None
Study Overview
Official Title:
Double-blind Randomized Placebo-controlled Trial to Explore the Improvement of Sleep Quality of Insomnia Patients With Binaural Beats
Status:
NOT_YET_RECRUITING
Status Verified Date:
2024-08
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
Not Stopped
Has Expanded Access:
No
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
None
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
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 113 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 34 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
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 34 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
Study Oversight
Has Oversight DMC:
None
Is a FDA Regulated Drug?:
None
Is a FDA Regulated Device?:
None
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
None
Is an FDA AA801 Violation?:
None