Exploration of the Effectiveness of Vibrational Intervention in Improving Insomnia Symptoms

Jia Xiu

Status: Enrolling

Conditions: Chronic Insomnia

Treatments: Other: Sham; Device: Vibrational stimulation

Study type: Interventional

Funder types: Other

Identifiers

NCT06983275

Vibrational sleep intervention

Details and patient eligibility

About

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

Enrollment: 120 estimated patients

Sex: All

Ages: 18 to 65 years old

Volunteers: No Healthy Volunteers

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.

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Triple Blind

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120 participants in 2 patient groups, including a placebo group

Control group

Placebo Comparator group

Description:

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.

Treatment:

Other: Sham

Intervention group

Experimental group

Description:

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.

Treatment:

Device: Vibrational stimulation