Exploration of the Effectiveness of Vibrational Intervention in Improving Insomnia Symptoms

Launched by JIA XIU · May 19, 2025

Keywords

ClinConnect Summary

This clinical trial is exploring whether a treatment called low-intensity frontal vibration can help improve sleep for people suffering from chronic insomnia. Chronic insomnia is a condition where individuals have trouble falling asleep for at least three times a week over a period of three months. The study aims to find out if this vibration treatment not only helps participants sleep better but also if it can enhance their memory. To compare the results, some participants will receive the actual vibration treatment, while others will experience a similar setup without the treatment, just hearing sounds related to it.

If you’re between 18 and 65 years old and have chronic insomnia, you might be eligible to participate. Throughout the study, which lasts for nine weeks, participants will keep track of their sleep habits using a mobile app and will receive daily treatment for four weeks. They will also answer questions about their sleep and take memory tests at the beginning and end of the study. It's important to note that certain conditions, like sleep disorders or significant mental health issues, may prevent someone from participating. This study is not yet recruiting participants, so keep an eye out for updates if you're interested!

Gender

ALL

Eligibility criteria

• Inclusion Criteria:
• • Aged 18 to 65 years, regardless of gender;
• • Diagnosed with chronic insomnia disorder according to DSM-5 criteria, with a primary complaint of difficulty falling asleep (sleep onset latency \> 30 minutes), occurring ≥3 times per week, lasting for more than 3 months but less than 3 years;
• • Able to independently operate a smartphone, and capable of completing self-reported assessments and applying the self-administered intervention after instruction.
• Exclusion Criteria:
• • Presence of sleep disorders such as sleep apnea syndrome or restless legs syndrome;
• • Epworth Sleepiness Scale (ESS) score \> 10;
• • Use of any sleep-related medication within the past month;
• • Patient Health Questionnaire-9 (PHQ-9) score \> 15 or Generalized Anxiety Disorder-7 (GAD-7) score \> 10;
• • Currently participating in any form of cognitive behavioral therapy or neuromodulation intervention study;
• • Working night shifts or rotating shifts;
• • Clinically diagnosed neurological disorders such as epilepsy, stroke, dementia, or Parkinson's disease, or psychiatric disorders such as bipolar disorder, obsessive-compulsive disorder, phobias, or panic disorder;
• • Substance abuse (including alcohol or drugs), defined as more than 14 drinks/week for males or 12 drinks/week for females.