Chronic InsomniaNCT06983275
Exploration of the Effectiveness of Vibrational Intervention in Improving Insomnia Symptoms
A study testing Vibrational stimulation in people with Chronic Insomnia, run by Jia Xiu at 1 site in China.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 to 65 years
- Conditions the study is for
- Chronic Insomnia
- What is being tested?
- Vibrational stimulation
- Type of treatment
- Medical device
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 120 participants
- Where
- 1 siteChina
- Study dates
- 1 Sep 2025to 1 Jun 2027
- Phase
- Interventional
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 65 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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.
Who cannot join
- 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 locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
China1 site, 1 recruiting
- Recruiting
Fudan University
Shanghai, Shanghai Municipality, 200433
Jia Xiu, 22110850035@m.fudan.edu.cn
About this study
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:
Read more
- 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
- Conditions
- Chronic Insomnia
- Being tested
- Vibrational stimulation, Sham
- Keywords
- chronic insomnia, vibrational neuromodulation, vibration
- Medical subject headings
- Sleep Initiation and Maintenance Disorders
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Vibrational stimulationDevice
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.
ShamOther
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.
| Study group | Role | What they receive |
|---|---|---|
| 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:
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. Receives: Other: Sham |
| 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:
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. Receives: Device: Vibrational stimulation |
What is being measured
The primary outcome is the main question the study is designed to answer.
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
Measured: 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)
Secondary outcomes (7)
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
Measured: 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)
Epworth Sleepiness Scale(ESS)
A scale that evaluates sleepiness, the scale scores range from 0 to 24, and lower scores mean a better outcome
Measured: 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
Measured: 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
Measured: 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.
Measured: 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
Measured: 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.
Measured: through study completion, an average of 63 days
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted21 May 2025
- Study start1 Sep 2025
- Primary completion1 Jun 2027 (estimated)
- Study completion1 Jun 2027 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Chronic InsomniaStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Triple blind
- Who is masked
- Care provider, Investigator, Outcomes assessor
- Enrolment
- 120 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Jia Xiu
- Sponsor type
- University, hospital or other
- Collaborators
- Shanghai Minhang Central Hospital, The Affiliated Nanjing Drum Tower Hospital of Nanjing University Medical School, The Affiliated Brain Hospital of Nanjing Medical University
- Responsible party
- Sponsor-investigator, Jia Xiu, Fudan University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06983275
- Sponsor's protocol ID
- Vibrational sleep intervention
- Status last verified
- Sep 2025
- First submitted
- 10 May 2025
- Last updated
- 19 Sep 2025
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Yes: All IPD that underlie results in a publication
Study at a glance
From the registry record, last updated by the sponsor on 19 Sep 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Exploration of the Effectiveness of Vibrational Intervention in Improving Insomnia Symptoms
- ClinicalTrials.gov ID
- NCT06983275
- Acronym / sponsor ID
- Vibrational sleep intervention
- Conditions
- Chronic Insomnia
- Keywords
- chronic insomnia, vibrational neuromodulation, vibration
- Study type
- Interventional
- Recruitment status
- Recruiting
- Enrolment
- 120 participants (estimated)
- Lead sponsor
- Jia XiuUniversity, hospital or other
- Collaborators
- Shanghai Minhang Central Hospital, The Affiliated Nanjing Drum Tower Hospital of Nanjing University Medical School, The Affiliated Brain Hospital of Nanjing Medical University
- Study start
- 1 Sep 2025 (actual)
- Primary completion
- 1 Jun 2027 (estimated)
- Study completion
- 1 Jun 2027 (estimated)
- First posted
- 21 May 2025 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Triple blind (care provider, investigator, outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Control group | Placebo comparator | Other: ShamThe 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. |
| Intervention group | Experimental | Device: Vibrational stimulationThe 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. |
Who may qualify
- Ages
- 18 to 65 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (3 listed)
- 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.
Key exclusion criteria (8 listed)
- 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;
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Vibrational stimulationFifteen 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. | Device | Intervention group |
| ShamFifteen 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. | Other | Control group |
Primary outcome
Pittsburgh Sleep Quality Index Scale(PSQI)
Time frame: 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
7 secondary outcomes
The Insomnia Severity Index Scale(ISI)
Time frame: 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)
Epworth Sleepiness Scale(ESS)
Time frame: 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)
Time frame: 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)
Time frame: 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
Time frame: Daily recording for the duration of the 63-day trial.
Memory Task
Time frame: 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
Time frame: through study completion, an average of 63 days
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 19 Sep 2025.
- Individual participant dataSharing planned: Yes. All IPD that underlie results in a publication
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Vibrational stimulation in people with Chronic Insomnia, run by Jia Xiu at 1 site in China.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 3 inclusion and 8 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: looking for participants now, as of the sponsor's last update on 19 Sep 2025. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in China. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. Some participants in this study may receive a placebo. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Jia Xiu, PhD (+86 15552382909, 22110850035@m.fudan.edu.cn), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Pittsburgh Sleep Quality Index Scale(PSQI) (time frame: 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)). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 19 Sep 2025.