Exploration of the Effectiveness of Vibrational Intervention in Improving Insomnia Symptoms

NCT06983275 | Recruiting

• 1 other identifier: Vibrational sleep intervention
• Study Type: interventional
• Target: 120
• Locations: 1 country
• Sites: 1

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

Conditions

Chronic Insomnia

Keywords

chronic insomnia; vibrational neuromodulation; vibration

Outcome Measures

Primary Outcomes (1)

• 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

  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 (7)

• The Insomnia Severity Index Scale(ISI)

  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)

  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)

  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)

  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

  Daily recording for the duration of the 63-day trial.

Study Arms (2)

Control group

PLACEBO COMPARATOR

The control group is designed to serve as a comparison to the intervention group, to determine whether the intervention produces real therapeutic effects. Participants in the control group will take part in a 9-week study, consisting of: 1. Week 1 (Adaptation Phase): Daily sleep diary recording 2. Weeks 2-5 (Intervention Phase): Daily sham stimulation and sleep diary recording 3. Weeks 6-9 (Follow-up Phase): Daily sleep diary recording Memory performance assessments will be conducted within one week following the adaptation phase and again within one week after the follow-up phase. Participants will also complete a sleep questionnaire once per week throughout the study.

Other: Sham

Intervention group

EXPERIMENTAL

The intervention group is designed to verify whether the stimulation yields true therapeutic effects in comparison to the control group. Participants in the intervention group will also undergo a 9-week study, consisting of: 1. Week 1 (Adaptation Phase): Daily sleep diary recording 2. Weeks 2-5 (Intervention Phase): Daily active stimulation and sleep diary recording 3. Weeks 6-9 (Follow-up Phase): Daily sleep diary recording Memory performance assessments will be conducted within one week following the adaptation phase and again within one week after the follow-up phase. Participants will complete a sleep questionnaire once per week throughout the study.

Device: Vibrational stimulation

Interventions

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.

Intervention group

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.

Control group

Eligibility Criteria

• Age: 18 Years - 65 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

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.

Sponsors & Collaborators

• Jia Xiu: lead
• Shanghai Minhang Central Hospital: collaborator
• The Affiliated Nanjing Drum Tower Hospital of Nanjing University Medical School: collaborator
• Nanjing Brain Hospital affiliated with Nanjing Medical University: collaborator

Study Sites (1)

Fudan University

Shanghai, Shanghai Municipality, 200433, China

RECRUITING

MeSH Terms

Conditions

Sleep Initiation and Maintenance Disorders

Interventions

salicylhydroxamic acid

Condition Hierarchy (Ancestors)

Sleep Disorders, Intrinsic; Dyssomnias; Sleep Wake Disorders; Nervous System Diseases; Mental Disorders

Central Study Contacts

Jia Xiu, PhD

CONTACT

+86 15552382909; 22110850035@m.fudan.edu.cn

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: TRIPLE
• Who Masked: CARE PROVIDER, INVESTIGATOR, OUTCOMES ASSESSOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR INVESTIGATOR
• PI Title: doctoral student

Study Record Dates

• First Submitted: May 10, 2025
• First Posted: May 21, 2025
• Study Start: September 1, 2025
• Primary Completion (Estimated): June 1, 2027
• Study Completion (Estimated): June 1, 2027
• Last Updated: September 19, 2025

Record last verified: 2025-09

Data Sharing

• IPD Sharing: Will share
• Shared Documents: STUDY PROTOCOL, SAP, ICF, CSR, ANALYTIC CODE
• Time Frame: Starting 6 months after publication
• Access Criteria: Refer the information in publication

Locations

CN (1)