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A cross-sectional study to explore the characteristics of near-infrared brain functional imaging in patients with chronic insomnia disorder

A cross-sectional study to explore the characteristics of near-infrared brain functional imaging in patients with chronic insomnia disorder

Status
Active, not recruiting
Phases
Unknown
Study type
Observational
Source
ChiCTR
Registry ID
ChiCTR2600125396
Enrollment
Unknown
Registered
2026-05-26
Start date
2026-05-27
Completion date
Unknown
Last updated
2026-06-01

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

Conditions

Insomia

Interventions

Insomnia observation group:None

Sponsors

Sun Yat-sen University Third Affiliated Hospital
Lead Sponsor

Eligibility

Sex/Gender
All
Age
18 Years to 80 Years

Inclusion criteria

Inclusion criteria: 1. Patients with chronic insomnia disorder (1) meeting the diagnostic criteria of chronic insomnia disorder in the International Classification of Sleep Disorders, Third Edition; (2) Pittsburgh sleep quality index (PSQI) score >=8, insomnia severity index (ISI) >=10; (3) Stable vital signs without severe aphasia, visual, hearing, or cognitive impairment, and able to complete the scale assessment and near-infrared brain function examination; (4) Patients aged 18-80 years old, with right dominant hand; (5) voluntarily participate in and sign the informed consent. 2. Healthy people (1) Pittsburgh sleep quality Index (PSQI) score < 8, insomnia severity index (ISI) < 10, self-rating anxiety scale (SAS) < 40, self-rating depression scale (SDS) < 43; (2) stable vital signs, able to complete the scale assessment and near-infrared brain function examination; (3) Patients aged 18-80 years old, with right dominant hand; (4) voluntarily participate in and sign the informed consent.

Exclusion criteria

Exclusion criteria: Patients with chronic insomnia disorder (1) There is a previous history of treatment with rTMS, tDCS, etc. (2) Patients with a history of organic brain diseases, brain trauma, stroke, severe mental disorders, craniotomy or skull defects; (3) History of drug abuse (caffeine, nicotine and alcohol); (4) Severe aphasia makes it impossible to complete the assessment; (5) Other serious diseases that may affect the research. 2. Healthy individuals (1) Those who have slept for less than 7 hours per night in the past month or have a travel history across time zones; (2) There is a history of previous treatments such as rTMS and tDCS; (3) Previous history of organic brain diseases, stroke, brain trauma, psychological disorders, mental disorders, craniotomy/skull defect, cervical spine, hypertension, heart failure, etc. (4) Previous self-reported symptoms such as insomnia (unable to fall asleep for more than 30 minutes), self-harm or suicidal thoughts, and migraines; (5) History of drug abuse (caffeine, nicotine and alcohol); (6) Severe aphasia makes it impossible to complete the assessment; (7) Other serious diseases that may affect the research.

Design outcomes

Primary

MeasureTime frame
Pittsburgh Sleep Quality Index Scale;

Secondary

MeasureTime frame
Insomnia Severity Index Scale;Self-rating Anxiety Scale;Self-rating Depression Scale;Near-infrared brain functional imaging;

Countries

China

Contacts

Public ContactZhang Liying

Sun Yat-sen University Third Affiliated Hospital

zhangliying_good@126.com+86 20 8217 9022

Outcome results

None listed

Source: ChiCTR (via WHO ICTRP) · Data processed: Jun 11, 2026