NCT06983275 Exploration of the Effectiveness of Vibrational Intervention in Improving Insomnia Symptoms
| NCT ID | NCT06983275 |
| Status | Recruiting |
| Phase | — |
| Sponsor | Jia Xiu |
| Condition | Chronic Insomnia |
| Study Type | INTERVENTIONAL |
| Enrollment | 120 participants |
| Start Date | 2025-09-01 |
| Primary Completion | 2027-06-01 |
Eligibility & Interventions
Eligibility Fast-Check
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What to Expect as a Participant
You will actively receive the study intervention — which may be a drug, biologic, device, or procedure.
This trial targets 120 participants in total. It began in 2025-09-01 with a primary completion date of 2027-06-01.
⚠ This information is for research awareness only. Always consult your physician before joining any clinical trial. Participation is voluntary and you may withdraw at any time.
Brief 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
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.
Contact & Investigator
Frequently Asked Questions
Who can join the NCT06983275 clinical trial?
This trial is open to participants of all sexes, aged 18 Years or older, up to 65 Years, studying Chronic Insomnia. Full inclusion and exclusion criteria are listed in the Eligibility Criteria section. Always confirm your eligibility with the research team before applying.
Is NCT06983275 currently recruiting?
Yes, NCT06983275 is actively recruiting participants. Contact the research team at 22110850035@m.fudan.edu.cn for enrollment information.
Where is the NCT06983275 trial being conducted?
This trial is being conducted at Shanghai, China.
Who is sponsoring the NCT06983275 clinical trial?
NCT06983275 is sponsored by Jia Xiu. The trial plans to enroll 120 participants.
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