Clinical Trial

Exploration of the Effectiveness of Vibrational Intervention in Improving Insomnia Symptoms

Recruiting
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Summary
Study Purpose The purpose of this clinical trial is to investigate whether low-intensity frontal vibration can improve sleep performance in individuals with chronic insomnia. Additionally, the study aims to explore its potential effects on memory enhancement. The primary objectives of the study are to address the following questions: * Does low-intensity frontal vibration improve sleep performance in patients with chronic insomnia? * Does low-intensity frontal vibration enhance memory performance in patients with chronic insomnia? Researchers will compare the effects of low-intensity frontal vibration with a sham stimulation (in which participants hear only noise associated with the vibration process) to determine whether the active intervention can effectively improve symptoms of chronic insomnia. Participant Involvement Participants in the study will: * Record daily sleep diaries via a mobile application for a total of 9 weeks * Receive daily intervention during a 4-week intervention phase as scheduled by the study * Complete weekly self-reported sleep questionnaires through the app * Undergo memory performance assessments at the beginning and end of the study
Protocol Amendment History 1 amendment
This ClinicalTrials.gov record has been amended once since 2025-05-19.
Status change: Not Yet Recruiting → Recruiting 2025-09-15
Trial Details
NCT Number NCT06983275
Lead Sponsor Jia Xiu
Collaborators: Shanghai Minhang Central Hospital, The Affiliated Nanjing Drum Tower Hospital of Nanjing University Medical School, The Affiliated Brain Hospital of Nanjing Medical University
Conditions Chronic Insomnia
Enrollment 120 participants
Start Date 2025-09-01
Primary Completion 2027-06-01 (estimated)
Study Completion 2027-06-01 (estimated)
Updated on ClinicalTrials.gov 2025-09-19