Exploration of the Effectiveness of Vibrational Intervention in Improving Insomnia Symptoms

Status: Recruiting
Location: See location...
Intervention Type: Device, Other
Study Type: Interventional
Study Phase: Not Applicable
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

Eligibility
Participation Requirements
Sex: All
Minimum Age: 18
Maximum Age: 65
Healthy Volunteers: f
View:

• 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.

Locations
Other Locations
China
Fudan University
RECRUITING
Shanghai
Contact Information
Primary
Jia Xiu, PhD
22110850035@m.fudan.edu.cn
+86 15552382909
Time Frame
Start Date: 2025-09-01
Estimated Completion Date: 2027-06-01
Participants
Target number of participants: 120
Treatments
Placebo_comparator: 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.
Experimental: 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.
Related Therapeutic Areas
Sponsors
Collaborators: The Affiliated Nanjing Drum Tower Hospital of Nanjing University Medical School, Shanghai Minhang Central Hospital, Nanjing Brain Hospital affiliated with Nanjing Medical University
Leads: Jia Xiu

This content was sourced from clinicaltrials.gov