Exploration of the Effectiveness of Vibrational Intervention in Improving Insomnia Symptoms

NARecruitingINTERVENTIONAL
Enrollment

120

Participants

Timeline

Start Date

September 1, 2025

Primary Completion Date

June 1, 2027

Study Completion Date

June 1, 2027

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.

Trial Locations (1)

200433

RECRUITING

Fudan University, Shanghai

All Listed Sponsors
collaborator

Shanghai Minhang Central Hospital

OTHER

collaborator

The Affiliated Nanjing Drum Tower Hospital of Nanjing University Medical School

OTHER

collaborator

Nanjing Brain Hospital affiliated with Nanjing Medical University

UNKNOWN

lead

Jia Xiu

OTHER

NCT06983275 - Exploration of the Effectiveness of Vibrational Intervention in Improving Insomnia Symptoms | Biotech Hunter | Biotech Hunter