Exploration of the Effectiveness of Vibrational Intervention in Improving Insomnia Symptoms

Jia Xiu120 enrolled

Overview

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

Study Type

INTERVENTIONAL

Allocation

RANDOMIZED

Purpose

TREATMENT

Masking

TRIPLE

Enrollment

120

Conditions

Chronic Insomnia

Interventions

Vibrational stimulationDEVICE

Fifteen minutes before bedtime, participants will wear a vibration stimulation device on the forehead while lying down in a comfortable position. The stimulation intensity will be set to 60% of the device's maximum output. Participants will receive a 15-minute session of 40 Hz vibration stimulation with a 50% duty cycle: 15 seconds of stimulation followed by 15 seconds of rest, repeated continuously. After the session, participants will remove the device and prepare for sleep immediately.

ShamOTHER

Fifteen minutes before bedtime, participants will lie down in a comfortable position and listen to the 40 Hz noise generated by the vibration device (without receiving actual vibration). After the session, they will remove the device and prepare for sleep immediately.

Eligibility

Sex: ALLMin age: 18 YearsMax age: 65 Years

Medical Language ↔ Plain English

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.

Outcomes

Primary Outcomes

Pittsburgh Sleep Quality Index Scale(PSQI)

A scale that evaluates sleep quality, the scale scores range from 0 to 21, and lower scores mean a better outcome

Time frame: 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

The Insomnia Severity Index Scale(ISI)

A scale that evaluates the severity of insomnia, the scale scores range from 0 to 28, and lower scores mean a better outcome

Time frame: 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)

Epworth Sleepiness Scale(ESS)

A scale that evaluates sleepiness, the scale scores range from 0 to 24, and lower scores mean a better outcome

Time frame: 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)

Patient Health Questionnaire (PHQ-9)

A scale that evaluates the severity of depression, the scale scores range from 0 to 27, and lower scores mean a better outcome

Time frame: 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)

Generalized Anxiety Disorder-7 (GAD-7)

A scale that evaluates anxiety, the scale scores range from 0 to 21, and lower scores mean a better outcome

Time frame: 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)

Sleep Diary

A sleep diary is a record of an individual's sleep and wake times, also sleep performence.

Time frame: Daily recording for the duration of the 63-day trial.

Memory Task

This task involves the sequential presentation of 40 pairs of nouns on a screen. Each word pair is displayed for 4 seconds, with a 1-second interval between pairs. The words within each pair are semantically related (e.g., brain - consciousness). Following the learning phase, participants complete an immediate cued-recall test. During this test, the first word of each pair is presented in a randomized order, and the participant is asked to verbally recall the second word. There is no time limit for each response. After each attempt, the correct answer is immediately displayed on the screen as feedback. Approximately 30 minutes later, a delayed recall test is administered using the same cued-recall procedure. However, no feedback is provided after the responses during this delayed test. Recall performance from both time points is used to calculate the offline gain in memory performance, defined as: Offline Gain (%) = ((Post-sleep Recall / Pre-sleep Rec

Time frame: 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)

Intervention Experience

Participants will be asked whether they experienced any discomfort during the intervention and to rate the perceived effectiveness of the intervention.

Time frame: through study completion, an average of 63 days

Exploration of the Effectiveness of Vibrational Intervention in Improving Insomnia Symptoms

Overview

Conditions

Interventions

Eligibility

Locations (1)

Outcomes

Primary Outcomes

Secondary Outcomes

Central Contacts