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Tests treatment safety and results for Chronic Insomnia
Official title Exploration of the Effectiveness of Vibrational Intervention in Improving Insomnia Symptoms
ClinicalTrials.gov ID: NCT06983275
What this study is testing
- What it's testing
- 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.
A plain-language read of the study's public ClinicalTrials.gov listing. The study team confirms the details.
Who can take part
Ages 18 to 65
You may be able to join if
- 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 \>...
- Able to independently operate a smartphone, and capable of completing self-reported assessments and applying the self-administered intervention after...
You likely can't join if
- 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;
See the full eligibility 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...
- Able to independently operate a smartphone, and capable of completing self-reported assessments and applying the self-administered intervention after instruction.
- 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.
The study team makes the final eligibility decision.
Where it's taking place
- Shanghai, Shanghai Municipality, China
Questions & answers
Do participants get paid in this trial?
This listing doesn't specify compensation. Many trials still reimburse travel or offer a stipend, so it's worth asking the study team when you connect.
Is it free to join, and do I need insurance?
Searching and applying through BridgeMD is free. In clinical trials the study-related treatment and visits are generally provided at no cost to you. You usually don't need insurance to take part - confirm specifics with the study team.
How long does this study last?
The listing doesn't state an exact length. The study team walks you through the schedule and number of visits before you decide to enroll.
Who can join this trial?
This study is enrolling all sexes, 18 years to 65 years. The study team makes the final eligibility decision.
Where is this trial taking place?
Study sites include Shanghai, Shanghai Municipality, China. Enter your location above to see the nearest site and check your eligibility.
Explore other conditions
BridgeMD is an information and trial-matching tool - not medical advice, and not the study sponsor. Details come from ClinicalTrials.gov; the study team decides eligibility.