Transcranial Temporal Interference Stimulation (tTIS) for Chronic Insomnia
ConditionChronic Insomnia
Trial statusNot yet recruiting
Trial phaseNot applicable
Trial typeInterventional
Biological sexAll
Age18-65
SponsorRuijin Hospital
About this trial
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.
Eligibility criteria
This trial does not accept healthy volunteersQualifiers
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.
Disqualifiers
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]).
Trial design
Design model
Parallel
Treatments tested in this trial
Active Transcranial Temporal Interference Stimulation (tTIS)-Experimental
DeviceUtilizing 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 Comparator
DeviceUtilizing 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.
Treatment groups
30 Participants
are divided into 2 treatment groupsGroup A: Experimental Group: 10Hz tTISExperimental treatment 1 intervention
Group B: Sham Comparator: 0Hz tTISSham comparator 1 intervention
Trial outcomes
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.
Time frame
Baseline (Day 1) and within 24 hours (0-24 h) after completion of the final treatment session on Day 13.Secondary outcomes
1
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, %).
Time frame
Baseline (Day 1) and within 24 hours (0-24 h) after completion of the final treatment session on Day 13.2
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, %).
Time frame
Baseline (Day 1) and within 24 hours (0-24 h) after completion of the final treatment session on Day 13.3
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).
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 44.4
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).
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.Other outcomes
1
Wearable-estimated light sleep proportion (HUAWEI Band 10)
Proportion of sleep time classified as "light sleep" by the HUAWEI Band 10 using the manufacturer's proprietary algorithm. Values will be derived from wearable device records during the monitoring period.
Time frame
Day 1 through Day 44.2
Wearable-estimated deep sleep proportion (HUAWEI Band 10)
Proportion of sleep time classified as "deep sleep" by the HUAWEI Band 10 using the manufacturer's proprietary algorithm. Values will be derived from wearable device records during the monitoring period.
Time frame
Day 1 through Day 44.3
Wearable-estimated REM sleep proportion (HUAWEI Band 10)
Proportion of sleep time classified as "REM sleep" by the HUAWEI Band 10 using the manufacturer's proprietary algorithm. Values will be derived from wearable device records during the monitoring period.
Time frame
Day 1 through Day 44.4
Heart rate variability (HRV) from wearable device (HUAWEI Band 10)
Heart rate variability (HRV) measured by the HUAWEI Band 10 and calculated using the manufacturer's proprietary algorithm. HRV metrics will be derived from wearable device records during the monitoring period.
Time frame
Day 1 through Day 44.Locations
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Source ClinicalTrials.gov
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