Efficacy of high-definition transcranial direct current stimulation (HD-tDCS) for sleep and cognitive function in patients with chronic insomnia: a double-blinded randomized controlled trial

Status

Active, not recruiting

Phases

Phase 2

Study type

Interventional

Source

ChiCTR

Registry ID

ChiCTR2600121282

Enrollment

Unknown

Registered

2026-03-27

Start date

2026-03-27

Completion date

Unknown

Last updated

2026-03-30

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Chronic Insomnia

Interventions

Sham stimulation group:Sham stimulation

Active stimulation group:High-definition transcranial direct current stimulation

Eligibility

Sex/Gender

All

Age

18 Years to 65 Years

Inclusion criteria

Inclusion criteria: 1. Aged 18 to 65 years. 2. Sex: No restriction. 3. Meets the ICSD-3 diagnostic criteria for chronic insomnia disorder (symptom frequency =3 times per week for =3 months). 4. A baseline total score on the Pittsburgh Sleep Quality Index (PSQI) > 8. 5. Chinese Han ethnicity and right-handed. 6. Has completed at least a primary school education (=6 years of formal schooling). 7. Capable of understanding the study and providing written informed consent.

Exclusion criteria

Exclusion criteria: 1. Presence of a severe somatic disease, or a mental disorder attributable to other physical illnesses. 2. History of epileptic seizures. 3. Comorbid or history of other severe mental disorders, or presence of a substance use disorder. 4. Prior treatment with other forms of electrical or magnetic stimulation therapy. 5. Presence of implanted medical devices (e.g., cardiac pacemaker, cochlear implant) or other contraindicated metal within the body. 6. Conditions contraindicating MRI scanning, such as claustrophobia. 7. Other sleep disorders including moderate to severe obstructive sleep apnea (Apnea-Hypopnea Index, AHI >15), periodic limb movement disorder (Periodic Limb Movement Index, PLMI >25), or parasomnias. 8. Severe depression (Patient Health Questionnaire-9 score >20), presence of psychotic features, or individuals deemed to be at high risk of suicide.

Design outcomes

Primary

Measure	Time frame
Morningnsee-eveningness questionnaire, MEQ ;sleep diary;Cognitive function test;Insomnia Severity Index, ISI;Pittsburgh sleep quality index, PSQI;	—

Secondary

Measure	Time frame
Patient Health Questionnaire-9, PHQ-9;Treatment Emergent Symptom Scale, TESS;Magnetic Resonance Imaging, MRI;Generalized Anxiety Disorder-7, GAD-7 ;Hamilton Depression Scale, HAMD ;	—

Countries

China

Contacts

Public ContactYicheng Long

Second Xiangya Hospital of CSU

yichenglong@csu.edu.cn+86 731 85292158

Outcome results

None listed

Source: ChiCTR (via WHO ICTRP) · Data processed: Apr 4, 2026