Chronic InsomniaNCT07755852
Transcranial Temporal Interference Stimulation (tTIS) for Chronic Insomnia
A study testing Active Transcranial Temporal Interference Stimulation (tTIS)-Experimental in people with Chronic Insomnia, run by Ruijin Hospital.
Trial summary
The purpose of this exploratory randomized controlled clinical trial is to evaluate the efficacy and safety of transcranial temporal interference stimulation (tTIS) in the treatment of chronic insomnia. 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?
- Active Transcranial Temporal Interference Stimulation (tTIS)-Experimental
- Type of treatment
- Medical device
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 30 participants
- Where
- No sites listed yet
- Study dates
- 30 Aug 2026to 30 Apr 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 old, male or female.
- Eligibility required an ICD-11 diagnosis of chronic insomnia disorder, determined by investigator-administered clinical interviews (≥3 nights/week for ≥3 months, despite adequate opportunity/conditions for sleep, with daytime distress or functional impairment).
- Insomnia Severity Index (ISI) total score ≥ 15 at screening or baseline assessment.
- Patient Health Questionnaire-9 (PHQ-9) and Generalized Anxiety Disorder-7 (GAD-7) total scores both ≤ 9 at screening assessment.
- Has full civil capacity, is able to proficiently operate a smartphone and wearable sleep band, and can understand and cooperate with clinical scale assessments and neurophysiological examinations.
- Voluntarily participates, can ensure on-time hospital visits for 10 transcranial temporal interference stimulation (tTIS) sessions over 2 consecutive weeks, and can cooperate with the 1-month longitudinal follow-up.
- Fully understands the study purpose, intervention procedures, and potential risks, and voluntarily signs the written informed consent form.
Who cannot join
- Psychiatric conditions: (1) schizophrenia spectrum disorder or bipolar disorder, determined based on participant self-report of prior clinician diagnosis and treatment history and, when feasible, review of available medical records; (2) moderate-to-severe depressive or anxiety symptoms (PHQ-9 ≥ 10 or GAD-7 ≥ 10; either threshold met); (3) current suicidal ideation/behavior or elevated suicide risk as assessed by the investigator.
- Secondary sleep disorders: Severe obstructive sleep apnea (OSA; AHI ≥ 30), restless legs syndrome (RLS), narcolepsy, or severe circadian rhythm disorders.
- Epilepsy risk: History of seizures/convulsions or a clear family history of epilepsy.
- Intracranial metal and implanted electronic devices: Intracranial metal implants (e.g., aneurysm clips, metal stents, repair patches; fixed dental fillings excluded) or implanted electronic devices (e.g., cardiac pacemakers, deep brain stimulators [DBS], vagus nerve stimulators [VNS]).
- Medical history (neurologic): Recent craniotomy, severe traumatic brain injury, or organic brain lesions (e.g., brain tumors).
- Special populations: Pregnant, lactating, or planning pregnancy during the study period.
- Skin and physical restrictions: Skin damage, infection, or severe rash at the scalp stimulation site (especially over the left DLPFC and the return electrode site), or severe allergy to conductive gel/electrodes.
- Somatic comorbidities/substance use: Severe cardiac, pulmonary, hepatic, or renal dysfunction, or other conditions deemed by the investigator to potentially affect participant safety or study assessments (e.g., severe alcohol or drug abuse).
Trial locations and contacts
No sites are listed yet. Contact the study team or a site near you to ask about taking part.
About this study
Official title: An Exploratory Randomized Controlled Clinical Trial of Transcranial Temporal Interference Stimulation (tTIS) for the Treatment of Chronic Insomnia
The purpose of this exploratory randomized controlled clinical trial is to evaluate the efficacy and safety of transcranial temporal interference stimulation (tTIS) in the treatment of chronic insomnia. The study aims to investigate whether non-invasive tTIS intervention can effectively modulate specific neural activities to improve sleep quality and alleviate related clinical symptoms in patients suffering from chronic insomnia.
Participants enrolled in this study will be randomly assigned to receive either active tTIS treatment or sham stimulation. Researchers will collect clinical assessments and sleep monitoring data before, during, and after the intervention to compare the outcomes between the different groups and determine the therapeutic potential of tTIS for insomnia management.
Read the detailed description
Background and Rationale:
Chronic insomnia involves not only difficulty initiating sleep but also continuous central hyperarousal, severely impairing daytime function and quality of life. Current sedative-hypnotic drugs typically provide only nighttime suppression of the central nervous system, which can lead to tolerance and next-day residual effects, and they fail to fundamentally restore normal brain network states. There is a clinical need for non-invasive neuromodulation targeting abnormal brain networks. The left dorsolateral prefrontal cortex (DLPFC) is implicated in regulating emotion and suppressing central hyperarousal. Transcranial temporal interference stimulation (tTIS) is a novel non-invasive technique that uses two high-frequency carriers to create a modulated envelope (e.g., 10Hz) at a specific cortical target. The 10Hz modulation is hypothesized to modulate alpha activity, potentially reducing cortical hyperarousal. This study will evaluate the clinical safety and preliminary efficacy of tTIS targeting the left DLPFC, and will test whether it is associated with network-level changes in insomnia patients.
Study Objective:
The primary objective is to evaluate the preliminary clinical efficacy of tTIS targeting the left DLPFC in treating chronic insomnia, utilizing the reduction rate of the Insomnia Severity Index (ISI) score as the primary endpoint. Secondary objectives include evaluating the clinical response rate and objective sleep structural changes via polysomnography (PSG) and sleep bands. The study will also explore the neurophysiological mechanisms by analyzing electroencephalogram (EEG) Alpha band power. Additionally, it will assess improvements in subjective arousal (PSAS) and emotional states (STAI-S, PHQ-9, GAD-7).
Study Design and Methodology:
This is a prospective, single-center, randomized, double-blind (participant and evaluator), sham-controlled exploratory clinical trial. Thirty eligible patients with primary or mild emotionally accompanied chronic insomnia will be enrolled and randomly assigned to either the experimental group (10Hz difference frequency tTIS) or the control group (0Hz difference frequency tTIS) in a 1:1 ratio. The study location is Ruijin Hospital, Shanghai Jiao Tong University School of Medicine.
Intervention Details:
Both groups will receive stimulation targeting the left DLPFC. The experimental group will receive 10Hz difference frequency tTIS (carrier frequencies of 2000Hz and 2010Hz), which creates an amplitude-modulated envelope. The control group will receive 0Hz difference frequency stimulation (identical carrier frequencies), which does not create a therapeutic modulated envelope. The intervention will be administered daily for 30 minutes per session, 5 times a week, over a continuous 2-week period (10 sessions in total). Follow-up assessments will cover the baseline, the end of the intervention, and one month post-intervention.
- Conditions
- Chronic Insomnia
- Being tested
- Active Transcranial Temporal Interference Stimulation (tTIS)-Experimental, Sham Transcranial Temporal Interference Stimulation (tTIS)-Sham Comparator
- Keywords
- Non-invasive Brain Stimulation, Chronic Insomnia, Dorsolateral Prefrontal Cortex
- 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.
Active Transcranial Temporal Interference Stimulation (tTIS)-ExperimentalDevice
Utilizing the NeuroDome TES NEURO-800 device to deliver active tTIS targeting the left dorsolateral prefrontal cortex (DLPFC). The stimulation uses carrier frequencies of 2000Hz and 2010Hz to generate a 10Hz amplitude-modulated envelope at the target region. Each session lasts for 30 minutes.
Sham Transcranial Temporal Interference Stimulation (tTIS)-Sham ComparatorDevice
Utilizing the NeuroDome TES NEURO-800 device to deliver sham tTIS targeting the left dorsolateral prefrontal cortex (DLPFC). The stimulation uses carrier frequencies of 2000Hz and 2000Hz to generate a 0Hz amplitude-modulated envelope at the target region. Each session lasts for 30 minutes.
| Study group | Role | What they receive |
|---|---|---|
| Experimental Group: 10Hz tTIS | Experimental | Participants in this group will receive active 10Hz difference frequency tTIS targeting the left dorsolateral prefrontal cortex (DLPFC). The intervention will be administered for 30 minutes per session, 5 times a week, over a continuous 2-week period (10 sessions in total) Receives: Device: Active Transcranial Temporal Interference Stimulation (tTIS)-Experimental |
| Sham Comparator: 0Hz tTIS | Sham comparator | Participants in this group will receive 0Hz difference frequency tTIS (sham stimulation) targeting the left DLPFC. The intervention frequency and duration are identical to the experimental group: 30 minutes per session, 5 times a week, for 2 weeks (10 sessions in total). Receives: Device: Sham Transcranial Temporal Interference Stimulation (tTIS)-Sham Comparator |
What is being measured
The primary outcome is the main question the study is designed to answer.
Change in Insomnia Severity Index (ISI) Score
The Insomnia Severity Index (ISI) is a validated 7-item self-report questionnaire used to assess the nature, severity, and impact of insomnia. The total score ranges from 0 to 28, with higher scores indicating more severe insomnia symptoms. The primary endpoint is the change from baseline in ISI total score at End of Intervention, calculated as ISI (Baseline) minus ISI (End of Intervention). Positive values indicate improvement.
Measured: Baseline (Day 1) and within 24 hours (0-24 h) after completion of the final treatment session on Day 13.
Secondary outcomes (13)
Insomnia Severity Index (ISI) Response Rate
ISI response is defined as a decrease of ≥6 points in the ISI total score from baseline to post-treatment. Participants will be classified as responders if their ISI total score decreases by ≥6 points from baseline (Day 1) to the post-treatment assessment completed within 24 hours (0-24 h) after completion of the final treatment session (Day 13). The response rate will be calculated as the proportion of responders in each group (n/N, %).
Measured: Baseline (Day 1) and within 24 hours (0-24 h) after completion of the final treatment session on Day 13.
Insomnia Severity Index (ISI) Remission Rate
ISI remission is defined as a post-treatment ISI total score <8 points. Participants will be classified as in remission if their ISI total score is <8 points at the post-treatment assessment completed within 24 hours (0-24 h) after completion of the final treatment session (Day 13). The remission rate will be calculated as the proportion of participants meeting this criterion in each group (n/N, %).
Measured: Baseline (Day 1) and within 24 hours (0-24 h) after completion of the final treatment session on Day 13.
Change from baseline in Pittsburgh Sleep Quality Index (PSQI) total score
Pittsburgh Sleep Quality Index (PSQI) total score (range 0-21; higher scores indicate worse sleep quality). Change from baseline will be calculated as baseline minus post-treatment and baseline minus end-of-follow-up; positive values indicate improvement (i.e., a reduction in PSQI total score).
Measured: Baseline (Day 1); within 24 hours (0-24 h) after completion of the final treatment session on Day 13; and end of follow-up on Day 44.
Pre-Sleep Arousal Scale (PSAS) score
PSAS score (range: 18-80; higher scores indicate greater pre-sleep arousal). Change from baseline will be calculated as baseline minus post-treatment and baseline minus end-of-follow-up; positive values indicate improvement (i.e., a reduction in PSAS score).
Measured: Baseline (Day 1); within 24 hours (0-24 h) after completion of the final treatment session on Day 13; and end of follow-up on Day 44.
State-Trait Anxiety Inventory-State (STAI-S) total score
STAI-S total score (range: 20 to 80; higher scores indicate greater state anxiety). Change from baseline will be calculated as baseline minus post-treatment; positive values indicate improvement (i.e., a reduction in STAI-S total score).
Measured: Baseline (Day 1); within 24 hours (0-24 h) after completion of the final treatment session on Day 13 and end of follow-up on Day 44.
Patient Health Questionnaire-9 (PHQ-9) total score
PHQ-9 total score (range: 0 to 27; higher scores indicate worse depressive symptoms). Change from baseline will be calculated as baseline minus post-treatment and baseline minus end-of-follow-up; positive values indicate improvement (i.e., a reduction in PHQ-9 total score).
Measured: Baseline (Day 1); within 24 hours (0-24 h) after completion of the final treatment session on Day 13; and end of follow-up on Day 44.
Generalized Anxiety Disorder-7 (GAD-7) total score
GAD-7 total score (range: 0 to 21; higher scores indicate worse anxiety symptoms). Change from baseline will be calculated as baseline minus post-treatment and baseline minus end-of-follow-up; positive values indicate improvement (i.e., a reduction in GAD-7 total score).
Measured: Baseline (Day 1); within 24 hours (0-24 h) after completion of the final treatment session on Day 13; and end of follow-up on Day 44.
Total sleep time (TST) by polysomnography (PSG)
Total sleep time (TST) measured by overnight polysomnography (PSG), in minutes. TST is defined as the total time scored as sleep during the PSG recording. Change from baseline will be calculated as post-treatment minus baseline.
Measured: Overnight on Day 1 and overnight on Day 13.
Sleep onset latency (SOL) by polysomnography (PSG)
Sleep onset latency (SOL) measured by overnight PSG, in minutes. SOL is defined as the time from lights out to sleep onset per standard PSG scoring. Change from baseline will be calculated as baseline minus post-treatment (positive values indicate shorter SOL).
Measured: Overnight on Day 1 and overnight on Day 13.
N1 sleep percentage (N1%) by polysomnography (PSG)
Percentage of total sleep time spent in stage N1 sleep (N1%), measured by overnight PSG (0-100%). Change from baseline will be calculated as post-treatment minus baseline (percentage points).
Measured: Overnight on Day 1 and overnight on Day 13.
N2 sleep percentage (N2%) by polysomnography (PSG)
Percentage of total sleep time spent in stage N2 sleep (N2%), measured by overnight PSG (0-100%). Change from baseline will be calculated as post-treatment minus baseline (percentage points).
Measured: Overnight on Day 1 and overnight on Day 13.
N3 sleep percentage (N3%) by polysomnography (PSG)
Percentage of total sleep time spent in stage N3 sleep (N3%), measured by overnight PSG (0-100%). Change from baseline will be calculated as post-treatment minus baseline (percentage points).
Measured: Overnight on Day 1 and overnight on Day 13.
REM sleep percentage (REM%) by polysomnography (PSG)
Percentage of total sleep time spent in REM sleep (REM%), measured by overnight PSG (0-100%). Change from baseline will be calculated as post-treatment minus baseline (percentage points).
Measured: Overnight on Day 1 and overnight on Day 13.
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted10 Aug 2026
- Study start30 Aug 2026 (estimated)
- Primary completion30 Mar 2027 (estimated)
- Study completion30 Apr 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.
- More trials run by Ruijin HospitalThe sponsor's other registered studies.
- 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
- Participant, Investigator, Outcomes assessor
- Enrolment
- 30 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Ruijin Hospital
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07755852
- Sponsor's protocol ID
- (2026)Lin Lun Shen No.(466)
- Status last verified
- Aug 2026
- First submitted
- 26 Jul 2026
- Last updated
- 10 Aug 2026
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Yes
Study at a glance
From the registry record, last updated by the sponsor on 10 Aug 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- An Exploratory Randomized Controlled Clinical Trial of Transcranial Temporal Interference Stimulation (tTIS) for the Treatment of Chronic Insomnia
- ClinicalTrials.gov ID
- NCT07755852
- Acronym / sponsor ID
- (2026)Lin Lun Shen No.(466)
- Conditions
- Chronic Insomnia
- Keywords
- Non-invasive Brain Stimulation, Chronic Insomnia, Dorsolateral Prefrontal Cortex
- Study type
- Interventional
- Recruitment status
- Not yet recruiting
- Enrolment
- 30 participants (estimated)
- Lead sponsor
- Ruijin HospitalUniversity, hospital or other
- Study start
- 30 Aug 2026 (estimated)
- Primary completion
- 30 Mar 2027 (estimated)
- Study completion
- 30 Apr 2027 (estimated)
- First posted
- 10 Aug 2026 (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.
The purpose of this exploratory randomized controlled clinical trial is to evaluate the efficacy and safety of transcranial temporal interference stimulation (tTIS) in the treatment of chronic insomnia. The study aims to investigate whether non-invasive tTIS intervention can effectively modulate specific neural activities to improve sleep quality and alleviate related clinical symptoms in patients suffering from chronic insomnia.
Participants enrolled in this study will be randomly assigned to receive either active tTIS treatment or sham stimulation. Researchers will collect clinical assessments and sleep monitoring data before, during, and after the intervention to compare the outcomes between the different groups and determine the therapeutic potential of tTIS for insomnia management.
Detailed description
Background and Rationale:
Chronic insomnia involves not only difficulty initiating sleep but also continuous central hyperarousal, severely impairing daytime function and quality of life. Current sedative-hypnotic drugs typically provide only nighttime suppression of the central nervous system, which can lead to tolerance and next-day residual effects, and they fail to fundamentally restore normal brain network states. There is a clinical need for non-invasive neuromodulation targeting abnormal brain networks. The left dorsolateral prefrontal cortex (DLPFC) is implicated in regulating emotion and suppressing central hyperarousal. Transcranial temporal interference stimulation (tTIS) is a novel non-invasive technique that uses two high-frequency carriers to create a modulated envelope (e.g., 10Hz) at a specific cortical target. The 10Hz modulation is hypothesized to modulate alpha activity, potentially reducing cortical hyperarousal. This study will evaluate the clinical safety and preliminary efficacy of tTIS targeting the left DLPFC, and will test whether it is associated with network-level changes in insomnia patients.
Study Objective:
The primary objective is to evaluate the preliminary clinical efficacy of tTIS targeting the left DLPFC in treating chronic insomnia, utilizing the reduction rate of the Insomnia Severity Index (ISI) score as the primary endpoint. Secondary objectives include evaluating the clinical response rate and objective sleep structural changes via polysomnography (PSG) and sleep bands. The study will also explore the neurophysiological mechanisms by analyzing electroencephalogram (EEG) Alpha band power. Additionally, it will assess improvements in subjective arousal (PSAS) and emotional states (STAI-S, PHQ-9, GAD-7).
Study Design and Methodology:
This is a prospective, single-center, randomized, double-blind (participant and evaluator), sham-controlled exploratory clinical trial. Thirty eligible patients with primary or mild emotionally accompanied chronic insomnia will be enrolled and randomly assigned to either the experimental group (10Hz difference frequency tTIS) or the control group (0Hz difference frequency tTIS) in a 1:1 ratio. The study location is Ruijin Hospital, Shanghai Jiao Tong University School of Medicine.
Intervention Details:
Both groups will receive stimulation targeting the left DLPFC. The experimental group will receive 10Hz difference frequency tTIS (carrier frequencies of 2000Hz and 2010Hz), which creates an amplitude-modulated envelope. The control group will receive 0Hz difference frequency stimulation (identical carrier frequencies), which does not create a therapeutic modulated envelope. The intervention will be administered daily for 30 minutes per session, 5 times a week, over a continuous 2-week period (10 sessions in total). Follow-up assessments will cover the baseline, the end of the intervention, and one month post-intervention.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Triple blind (participant, investigator, outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Experimental Group: 10Hz tTIS | Experimental | Device: Active Transcranial Temporal Interference Stimulation (tTIS)-ExperimentalParticipants in this group will receive active 10Hz difference frequency tTIS targeting the left dorsolateral prefrontal cortex (DLPFC). The intervention will be administered for 30 minutes per session, 5 times a week, over a continuous 2-week period (10 sessions in total) |
| Sham Comparator: 0Hz tTIS | Sham comparator | Device: Sham Transcranial Temporal Interference Stimulation (tTIS)-Sham ComparatorParticipants in this group will receive 0Hz difference frequency tTIS (sham stimulation) targeting the left DLPFC. The intervention frequency and duration are identical to the experimental group: 30 minutes per session, 5 times a week, for 2 weeks (10 sessions in total). |
Who may qualify
- Ages
- 18 to 65 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (7 listed)
- Aged 18 to 65 years old, male or female.
- Eligibility required an ICD-11 diagnosis of chronic insomnia disorder, determined by investigator-administered clinical interviews (≥3 nights/week for ≥3 months, despite adequate opportunity/conditions for sleep, with daytime distress or functional impairment).
- Insomnia Severity Index (ISI) total score ≥ 15 at screening or baseline assessment.
- Patient Health Questionnaire-9 (PHQ-9) and Generalized Anxiety Disorder-7 (GAD-7) total scores both ≤ 9 at screening assessment.
- Has full civil capacity, is able to proficiently operate a smartphone and wearable sleep band, and can understand and cooperate with clinical scale assessments and neurophysiological examinations.
Key exclusion criteria (8 listed)
- Psychiatric conditions: (1) schizophrenia spectrum disorder or bipolar disorder, determined based on participant self-report of prior clinician diagnosis and treatment history and, when feasible, review of available medical records; (2) moderate-to-severe depressive or anxiety symptoms (PHQ-9 ≥ 10 or GAD-7 ≥ 10; either threshold met); (3) current suicidal ideation/behavior or elevated suicide risk as assessed by the investigator.
- Secondary sleep disorders: Severe obstructive sleep apnea (OSA; AHI ≥ 30), restless legs syndrome (RLS), narcolepsy, or severe circadian rhythm disorders.
- Epilepsy risk: History of seizures/convulsions or a clear family history of epilepsy.
- Intracranial metal and implanted electronic devices: Intracranial metal implants (e.g., aneurysm clips, metal stents, repair patches; fixed dental fillings excluded) or implanted electronic devices (e.g., cardiac pacemakers, deep brain stimulators [DBS], vagus nerve stimulators [VNS]).
- Medical history (neurologic): Recent craniotomy, severe traumatic brain injury, or organic brain lesions (e.g., brain tumors).
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 |
|---|---|---|
| Active Transcranial Temporal Interference Stimulation (tTIS)-ExperimentalUtilizing the NeuroDome TES NEURO-800 device to deliver active tTIS targeting the left dorsolateral prefrontal cortex (DLPFC). The stimulation uses carrier frequencies of 2000Hz and 2010Hz to generate a 10Hz amplitude-modulated envelope at the target region. Each session lasts for 30 minutes. | Device | Experimental Group: 10Hz tTIS |
| Sham Transcranial Temporal Interference Stimulation (tTIS)-Sham ComparatorUtilizing the NeuroDome TES NEURO-800 device to deliver sham tTIS targeting the left dorsolateral prefrontal cortex (DLPFC). The stimulation uses carrier frequencies of 2000Hz and 2000Hz to generate a 0Hz amplitude-modulated envelope at the target region. Each session lasts for 30 minutes. | Device | Sham Comparator: 0Hz tTIS |
Primary outcome
Change in Insomnia Severity Index (ISI) Score
Time frame: Baseline (Day 1) and within 24 hours (0-24 h) after completion of the final treatment session on Day 13.
The Insomnia Severity Index (ISI) is a validated 7-item self-report questionnaire used to assess the nature, severity, and impact of insomnia. The total score ranges from 0 to 28, with higher scores indicating more severe insomnia symptoms. The primary endpoint is the change from baseline in ISI total score at End of Intervention, calculated as ISI (Baseline) minus ISI (End of Intervention). Positive values indicate improvement.
13 secondary outcomes
Insomnia Severity Index (ISI) Response Rate
Time frame: Baseline (Day 1) and within 24 hours (0-24 h) after completion of the final treatment session on Day 13.
Insomnia Severity Index (ISI) Remission Rate
Time frame: Baseline (Day 1) and within 24 hours (0-24 h) after completion of the final treatment session on Day 13.
Change from baseline in Pittsburgh Sleep Quality Index (PSQI) total score
Time frame: Baseline (Day 1); within 24 hours (0-24 h) after completion of the final treatment session on Day 13; and end of follow-up on Day 44.
Pre-Sleep Arousal Scale (PSAS) score
Time frame: Baseline (Day 1); within 24 hours (0-24 h) after completion of the final treatment session on Day 13; and end of follow-up on Day 44.
State-Trait Anxiety Inventory-State (STAI-S) total score
Time frame: Baseline (Day 1); within 24 hours (0-24 h) after completion of the final treatment session on Day 13 and end of follow-up on Day 44.
Patient Health Questionnaire-9 (PHQ-9) total score
Time frame: Baseline (Day 1); within 24 hours (0-24 h) after completion of the final treatment session on Day 13; and end of follow-up on Day 44.
Generalized Anxiety Disorder-7 (GAD-7) total score
Time frame: Baseline (Day 1); within 24 hours (0-24 h) after completion of the final treatment session on Day 13; and end of follow-up on Day 44.
Total sleep time (TST) by polysomnography (PSG)
Time frame: Overnight on Day 1 and overnight on Day 13.
Sleep onset latency (SOL) by polysomnography (PSG)
Time frame: Overnight on Day 1 and overnight on Day 13.
N1 sleep percentage (N1%) by polysomnography (PSG)
Time frame: Overnight on Day 1 and overnight on Day 13.
N2 sleep percentage (N2%) by polysomnography (PSG)
Time frame: Overnight on Day 1 and overnight on Day 13.
N3 sleep percentage (N3%) by polysomnography (PSG)
Time frame: Overnight on Day 1 and overnight on Day 13.
REM sleep percentage (REM%) by polysomnography (PSG)
Time frame: Overnight on Day 1 and overnight on Day 13.
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 10 Aug 2026.
- Individual participant dataSharing planned: Yes
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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.
Questions about this trial
What is this clinical trial studying?
A study testing Active Transcranial Temporal Interference Stimulation (tTIS)-Experimental in people with Chronic Insomnia, run by Ruijin Hospital.
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 7 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: opening soon, as of the sponsor's last update on 10 Aug 2026. Status can change between updates, so confirm with the study contact before making plans.
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 Yan Luo, MD, PhD (0086-021-64370045 ext. 666225, zhy12015@rjh.com.cn), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Change in Insomnia Severity Index (ISI) Score (time frame: Baseline (Day 1) and within 24 hours (0-24 h) after completion of the final treatment session on Day 13.). 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 10 Aug 2026.