Chronic Insomnia
Conditions
Keywords
chronic insomnia, vibrational neuromodulation, vibration
Brief 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
Interventions
DEVICEVibrational 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.
OTHERSham
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
Shanghai Minhang Central Hospital
The Affiliated Nanjing Drum Tower Hospital of Nanjing University Medical School
Nanjing Brain Hospital affiliated with Nanjing Medical University
Jia Xiu
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
TRIPLE (Caregiver, Investigator, Outcomes Assessor)
Eligibility
Sex/Gender
ALL
Age
18 Years to 65 Years
Healthy volunteers
No
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.
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Pittsburgh Sleep Quality Index Scale(PSQI) | baseline(Day 1); intervention stage(The last day of each week during 4-week intervention); follow-up stage(The last day of each week during 4-week follow-up) | A scale that evaluates sleep quality, the scale scores range from 0 to 21, and lower scores mean a better outcome |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Epworth Sleepiness Scale(ESS) | baseline(Day 1); intervention stage(The last day of each week during 4-week intervention); follow-up stage(The last day of each week during 4-week follow-up) | A scale that evaluates sleepiness, the scale scores range from 0 to 24, and lower scores mean a better outcome |
| Patient Health Questionnaire (PHQ-9) | baseline(Day 1); intervention stage(The last day of each week during 4-week intervention); follow-up stage(The last day of each week during 4-week follow-up) | A scale that evaluates the severity of depression, the scale scores range from 0 to 27, and lower scores mean a better outcome |
| Generalized Anxiety Disorder-7 (GAD-7) | baseline(Day 1); intervention stage(The last day of each week during 4-week intervention); follow-up stage(The last day of each week during 4-week follow-up) | A scale that evaluates anxiety, the scale scores range from 0 to 21, and lower scores mean a better outcome |
| The Insomnia Severity Index Scale(ISI) | baseline(Day 1); intervention stage(The last day of each week during 4-week intervention); follow-up stage(The last day of each weekduring 4-week follow-up) | A scale that evaluates the severity of insomnia, the scale scores range from 0 to 28, and lower scores mean a better outcome |
| Memory Task | baseline(Day 1); intervention stage(The last day of 4-week intervention, an average of Day 35); follow-up stage(The last day 4-week stage, an average of Day 63) | This task involves the sequential presentation of 40 pairs of nouns on a screen. Each word pair is displayed for 4 seconds, with a 1-second interval between pairs. The words within each pair are semantically related (e.g., brain - consciousness). Following the learning phase, participants complete an immediate cued-recall test. During this test, the first word of each pair is presented in a randomized order, and the participant is asked to verbally recall the second word. There is no time limit for each response. After each attempt, the correct answer is immediately displayed on the screen as feedback. Approximately 30 minutes later, a delayed recall test is administered using the same cued-recall procedure. However, no feedback is provided after the responses during this delayed test. Recall performance from both time points is used to calculate the offline gain in memory performance, defined as: Offline Gain (%) = ((Post-sleep Recall / Pre-sleep Rec |
| Intervention Experience | through study completion, an average of 63 days | Participants will be asked whether they experienced any discomfort during the intervention and to rate the perceived effectiveness of the intervention. |
| Sleep Diary | Daily recording for the duration of the 63-day trial. | A sleep diary is a record of an individual's sleep and wake times, also sleep performence. |
Countries
China
Contacts
Primary ContactJia Xiu, PhD
Outcome results
None listed