Double-blind, Randomized, Placebo-controlled Trial to Explore the Improvement of Sleep Quality of Insomnia Patients with Binaural Beats

Status: Recruiting
Location: See location...
Intervention Type: Device
Study Type: Interventional
Study Phase: Not Applicable
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

Eligibility
Participation Requirements
Sex: All
Minimum Age: 20
Maximum Age: 75
Healthy Volunteers: f
View:

• 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.

Locations
Other Locations
Taiwan
Chang Gung Memorial Hospital
RECRUITING
Taoyuan District
Contact Information
Primary
Yi-Min Fang, MD
butterlion721@gmail.com
+886931776313
Time Frame
Start Date: 2024-12-27
Estimated Completion Date: 2025-08-31
Participants
Target number of participants: 74
Treatments
Experimental: Binaural Beats
Sham_comparator: Placebo
Related Therapeutic Areas
Sponsors
Leads: Chang Gung Memorial Hospital

This content was sourced from clinicaltrials.gov