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NCT Number: NCT06983275

Exploration of the Effectiveness of Vibrational Intervention in Improving Insomnia Symptoms

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

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Key information

Conditions

Chronic Insomnia Dyssomnias Mental Disorders Nervous System Diseases Sleep Disorders, Intrinsic Sleep Initiation and Maintenance Disorders Sleep Wake Disorders

Age range

18 year–65 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Fudan University

Shanghai, Shanghai Municipality, 200433, China

Location status: Recruiting

Location contact

Jia Xiu

CONTACT

[email protected]

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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.

Treatment and study plan

Vibrational stimulation

Device

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.

SHAM

Other

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.

Primary outcomes

  1. Pittsburgh Sleep Quality Index Scale(PSQI)

    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)

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

Secondary outcomes

  1. The Insomnia Severity Index Scale(ISI)

    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)

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

  2. Epworth Sleepiness Scale(ESS)

    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)

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

  3. Patient Health Questionnaire (PHQ-9)

    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)

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

  4. Generalized Anxiety Disorder-7 (GAD-7)

    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)

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

  5. Sleep Diary

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

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

  6. Memory Task

    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)

    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

  7. Intervention Experience

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

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

Study contacts

Contact information is provided by the study sponsor or research team.

Jia Xiu, PhD

CONTACT

[email protected]

+86 15552382909

Sponsors and collaborators

Lead sponsor

Jia Xiu

Other

Collaborators

  • Shanghai Minhang Central Hospital
  • The Affiliated Brain Hospital of Nanjing Medical University
  • The Affiliated Nanjing Drum Tower Hospital of Nanjing University Medical School

Registry information

Important dates

Study start
2025
Primary completion
2027
Study completion
2027
First posted
May 21, 2025
Registry last updated
Sep 19, 2025

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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