The Effects of Transcranial Current Stimulation on Insomnia

NCT ID: NCT07340268

Last Updated: 2026-02-04

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

RECRUITING

Clinical Phase

NA

Total Enrollment

100 participants

Study Classification

INTERVENTIONAL

Study Start Date

2026-01-18

Study Completion Date

2026-12-31

Brief Summary

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Effect of transcranial current stimulation on insomnia disorder

Detailed Description

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Insomnia disorder represents a prevalent clinical challenge, transcranial current stimulation has emerged as a promising noninvasive therapeutic approach; however, its specific effects on neurophysiological mechanisms underlying sleep-related brain structure and functional change, and neurobiological change remain unclear.

Conditions

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Insomnia, Psychophysiological

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

TREATMENT

Blinding Strategy

QUADRUPLE

Participants Caregivers Investigators Outcome Assessors

Study Groups

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active transcranial current stimulation

14 daily 20-min, 1.1-mA sessions of active or sham transcranial current stimulation, at the beginning and end of treatment, there is a 30 second period of current fading in and out

Group Type ACTIVE_COMPARATOR

transcranial current stimulation

Intervention Type DEVICE

consecutive daily 20-min, 1.1-mA sessions

sham transcranial current stimulation

only wore the device and had no stimulation

Group Type SHAM_COMPARATOR

Sham stimulation

Intervention Type DEVICE

only wore the device and had no stimulation

Interventions

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transcranial current stimulation

consecutive daily 20-min, 1.1-mA sessions

Intervention Type DEVICE

Sham stimulation

only wore the device and had no stimulation

Intervention Type DEVICE

Eligibility Criteria

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Inclusion Criteria

* Clinical diagnosis of insomnia disorder
* Cooperate to complete the questionnaire surveys

Exclusion Criteria

* Presence of mental disorders
* Current use of central nervous system stimulants
* Use of analgesics,sedatives or hypnotic medications, theophylline preparations, steroid medications
* Alcohol abuse or regular alcohol consumption
* Diagnosis of other sleep disorders, including obstructive sleep apnea, rapid eye movement sleep behavior disorder, or restless legs syndrome
* Sleep disorders secondary to organic diseases, such as epilepsy, diabetes, or renal failure
* Shift work or irregular work schedules that disrupt normal circadian rhythms
* Use of medications affecting central nervous system function within the past one month
* Recent sleep-related confounding behaviors within the past two weeks, including staying up late, alcohol consumption, or smoking
* Presence of organic brain lesions on head MRI and contraindications to MRI examination
Minimum Eligible Age

18 Years

Maximum Eligible Age

75 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

Yes

Sponsors

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Zan Wang

OTHER

Sponsor Role lead

Responsible Party

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Zan Wang

Sleep Center Director

Responsibility Role SPONSOR_INVESTIGATOR

Locations

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the First Hospital of Jilin University

Ch’ang-ch’un, Jilin, China

Site Status COMPLETED

the First Hospital of Jilin University

Ch’ang-ch’un, Jilin, China

Site Status RECRUITING

Countries

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China

Central Contacts

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Zan Wang, MD, PhD

Role: CONTACT

+86 88782678

Facility Contacts

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Zan Wang Prof, PhD

Role: primary

+86-13843025938

Other Identifiers

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TCS-V01

Identifier Type: -

Identifier Source: org_study_id

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