Clinical trial NCT06983275: Exploration of the Effectiveness of Vibrational Intervention in Improving Insomnia Symptoms
Official title: Exploration of the Effectiveness of Vibrational Intervention in Improving Insomnia Symptoms
Study type: INTERVENTIONAL
Overall status: NOT_YET_RECRUITING
Phase: NA
Conditions: Chronic Insomnia
Keywords: chronic insomnia
vibrational neuromodulation
vibration
Lead sponsor: Fudan University
Sponsor class: OTHER
Collaborators: name: Shanghai Minhang Central Hospital
First posted: 2025-05-21
Enrollment: 120
Sex: ALL
Minimum age (years): 18
Maximum age (years): 65
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

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.

Primary outcomes:
measure: Pittsburgh Sleep Quality Index Scale(PSQI)
timeFrame: baseline(Day 1); intervention stage(The last day of each week during 4-week intervention); follow-up stage(The last day of each week during 4-week follow-up)
Secondary outcomes:
measure: The Insomnia Severity Index Scale(ISI)
timeFrame: baseline(Day 1); intervention stage(The last day of each week during 4-week intervention); follow-up stage(The last day of each weekduring 4-week follow-up)
measure: Epworth Sleepiness Scale(ESS)
timeFrame: baseline(Day 1); intervention stage(The last day of each week during 4-week intervention); follow-up stage(The last day of each week during 4-week follow-up)
measure: Patient Health Questionnaire (PHQ-9)
timeFrame: baseline(Day 1); intervention stage(The last day of each week during 4-week intervention); follow-up stage(The last day of each week during 4-week follow-up)
measure: Generalized Anxiety Disorder-7 (GAD-7)
timeFrame: baseline(Day 1); intervention stage(The last day of each week during 4-week intervention); follow-up stage(The last day of each week during 4-week follow-up)
measure: Sleep Diary
timeFrame: Daily recording for the duration of the 63-day trial.
measure: Memory Task
timeFrame: baseline(Day 1); intervention stage(The last day of 4-week intervention, an average of Day 35); follow-up stage(The last day 4-week stage, an average of Day 63)
measure: Intervention Experience
timeFrame: through study completion, an average of 63 days
Other outcomes:
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