Exploration of the Effectiveness of Vibrational Intervention in Improving Insomnia Symptoms

Recruiting now · Not applicable · Has a placebo group

Conditions studied: Chronic Insomnia

In brief

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

Key facts

Study ID

NCT06983275

Run by

Jia Xiu

People needed

120

Starts

2025-09-01

Expected to finish

2027-06-01

Last updated by the study team

2025-09-19

Who can join

Age: 18 and older, up to 65. Sex: any. Healthy volunteers: not accepted.

You may qualify if…

• 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.

You may not qualify if…

• 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.

Where it is running

• Fudan University — Shanghai, Shanghai Municipality, China (enrolling)

Full record on ClinicalTrials.gov

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