Transcranial Temporal Interference Stimulation (tTIS) for Chronic Insomnia

NCT07755852 | Not Yet Recruiting DMC

• 1 other identifier: (2026)Lin Lun Shen No.(466)
• Study Type: interventional
• Target: 30
• Locations: 0 countries
• Sites: N/A

Brief 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. 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.

Conditions

Chronic Insomnia

Keywords

Non-invasive Brain Stimulation; Chronic Insomnia; Dorsolateral Prefrontal Cortex

Outcome Measures

Primary Outcomes (1)

• 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.

  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

  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

  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

  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

  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

  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.

Other Outcomes (4)

• Wearable-estimated light sleep proportion (HUAWEI Band 10)

  Day 1 through Day 44.

• Wearable-estimated deep sleep proportion (HUAWEI Band 10)

  Day 1 through Day 44.

• Wearable-estimated REM sleep proportion (HUAWEI Band 10)

  Day 1 through Day 44.

Study Arms (2)

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)

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).

Device: Sham Transcranial Temporal Interference Stimulation (tTIS)-Sham Comparator

Interventions

Active Transcranial Temporal Interference Stimulation (tTIS)-Experimental DEVICE

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.

Experimental Group: 10Hz tTIS

Sham Transcranial Temporal Interference Stimulation (tTIS)-Sham Comparator DEVICE

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.

Sham Comparator: 0Hz tTIS

Eligibility Criteria

• Age: 18 Years - 65 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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.

You may not qualify if:

• 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).

Sponsors & Collaborators

• Ruijin Hospital: lead

MeSH Terms

Conditions

Sleep Initiation and Maintenance Disorders

Condition Hierarchy (Ancestors)

Sleep Disorders, Intrinsic; Dyssomnias; Sleep Wake Disorders; Nervous System Diseases; Mental Disorders

Central Study Contacts

Yan Luo, MD, PhD

CONTACT

0086-021-64370045; zhy12015@rjh.com.cn

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: TRIPLE
• Who Masked: PARTICIPANT, INVESTIGATOR, OUTCOMES ASSESSOR
• Masking Details: Participants, clinical investigators, and outcome assessors (including data statisticians) are strictly blinded to the group allocation. The device operators who set the tTIS stimulation parameters are unblinded, but they are strictly prohibited from participating in any clinical scale follow-up, PSG collection, or clinical outcome evaluation to prevent bias transmission.
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: July 26, 2026
• First Posted: August 10, 2026
• Study Start (Estimated): August 30, 2026
• Primary Completion (Estimated): March 30, 2027
• Study Completion (Estimated): April 30, 2027
• Last Updated: August 10, 2026

Record last verified: 2026-08

Data Sharing

• IPD Sharing: Will share
• Shared Documents: STUDY PROTOCOL, SAP
• Time Frame: Data will be available immediately following the publication of the main study results, with no specified end date.
• Access Criteria: Data will be shared with researchers who provide a scientifically sound proposal. To gain access, data requestors must contact the Principal Investigator (PI) and sign a formal data use agreement. The shared data is intended exclusively to promote further scientific communication and evidence-based research regarding physical neuromodulation in the field of sleep medicine.