Exploration of the Effectiveness of Vibrational Intervention in Improving Insomnia Symptoms

NCT ID: NCT06983275

Last Updated: 2025-09-19

Basic Information

• Recruitment Status: RECRUITING
• Clinical Phase: NA
• Total Enrollment: 120 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2025-09-01
• Study Completion Date: 2027-06-01

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

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: TREATMENT
• Blinding Strategy: TRIPLE

Study Groups

Control group

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.

Group Type: PLACEBO_COMPARATOR

Sham

Intervention Type: 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.

Intervention group

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.

Group Type: EXPERIMENTAL

Vibrational stimulation

Intervention Type: 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.

Interventions

Vibrational stimulation

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 Type: DEVICE

Sham

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.

Intervention Type: OTHER

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.

• Minimum Eligible Age: 18 Years
• Maximum Eligible Age: 65 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Shanghai Minhang Central Hospital

OTHER

Sponsor Role: collaborator

The Affiliated Nanjing Drum Tower Hospital of Nanjing University Medical School

OTHER

Sponsor Role: collaborator

Nanjing Brain Hospital affiliated with Nanjing Medical University

UNKNOWN

Sponsor Role: collaborator

Jia Xiu

OTHER

Sponsor Role: lead

Responsible Party

Jia Xiu

doctoral student

Responsibility Role: SPONSOR_INVESTIGATOR

Locations

Fudan University

Shanghai, Shanghai Municipality, China

Site Status: RECRUITING

Countries

China

Central Contacts

Jia Xiu, PhD

Role: CONTACT

22110850035@m.fudan.edu.cn

+86 15552382909

Facility Contacts

Jia Xiu

Role: primary

22110850035@m.fudan.edu.cn

Other Identifiers

Vibrational sleep intervention

Identifier Type: -

Identifier Source: org_study_id