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| Name | Class |
|---|---|
| Shanghai Minhang Central Hospital | OTHER |
| The Affiliated Nanjing Drum Tower Hospital of Nanjing University Medical School | OTHER |
| The Affiliated Brain Hospital of Nanjing Medical University | OTHER_GOV |
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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:
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:
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Control group | Placebo Comparator | 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:
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| Intervention group | Experimental | 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:
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| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Vibrational stimulation | Device | 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. |
| Measure | Description | Time Frame |
|---|---|---|
| Pittsburgh Sleep Quality Index Scale(PSQI) | A scale that evaluates sleep quality, the scale scores range from 0 to 21, and lower scores mean a better outcome | 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) |
| Measure | Description | Time Frame |
|---|---|---|
| The Insomnia Severity Index Scale(ISI) | A scale that evaluates the severity of insomnia, the scale scores range from 0 to 28, and lower scores mean a better outcome | 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) |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Role | Phone | Extension | |
|---|---|---|---|---|
| Jia Xiu, PhD | Contact | +86 15552382909 | 22110850035@m.fudan.edu.cn |
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| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Fudan University | Recruiting | Shanghai | Shanghai Municipality | 200433 | China |
All IPD that underlie results in a publication
Starting 6 months after publication
Refer the information in publication
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| ID | Term |
|---|---|
| D007319 | Sleep Initiation and Maintenance Disorders |
| ID | Term |
|---|---|
| D020919 | Sleep Disorders, Intrinsic |
| D020920 | Dyssomnias |
| D012893 | Sleep Wake Disorders |
| D009422 | Nervous System Diseases |
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| ID | Term |
|---|---|
| C005703 | salicylhydroxamic acid |
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| Sham | Other | 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. |
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| Epworth Sleepiness Scale(ESS) |
A scale that evaluates sleepiness, the scale scores range from 0 to 24, and lower scores mean a better outcome |
| 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) |
| Patient Health Questionnaire (PHQ-9) | A scale that evaluates the severity of depression, the scale scores range from 0 to 27, and lower scores mean a better outcome | 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) |
| Generalized Anxiety Disorder-7 (GAD-7) | A scale that evaluates anxiety, the scale scores range from 0 to 21, and lower scores mean a better outcome | 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) |
| Sleep Diary | A sleep diary is a record of an individual's sleep and wake times, also sleep performence. | Daily recording for the duration of the 63-day trial. |
| Memory Task | 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 | 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) |
| Intervention Experience | Participants will be asked whether they experienced any discomfort during the intervention and to rate the perceived effectiveness of the intervention. | through study completion, an average of 63 days |
| D001523 |
| Mental Disorders |