Exploration of the Effectiveness of Vibrational Intervention in Improving Insomnia Symptoms

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

Interventions

DEVICE

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.

OTHER

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.

Sponsors & Collaborators

• Shanghai Minhang Central Hospital

  collaborator OTHER

• The Affiliated Nanjing Drum Tower Hospital of Nanjing University Medical School

  collaborator OTHER

• Nanjing Brain Hospital affiliated with Nanjing Medical University

  collaborator UNKNOWN

• Jia Xiu

  lead OTHER

Study Design

Allocation

RANDOMIZED

Purpose

TREATMENT

Masking

TRIPLE

Model

PARALLEL

Eligibility

Min Age

18 Years

Max Age

65 Years

Sex

ALL

Healthy Volunteers

No

Timeline & Regulatory

Start

2025-09-01

Primary Completion

2027-06-01

Completion

2027-06-01

Countries

• China

Study Locations