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A single-arm, pre-post controlled study to evaluate the efficacy and safety of near-infrared photobiomodulation therapy in patients with insomnia disorder.

A study on the Efficacy and Safety of Nea-Infrared PhotobiomodulationTherapy in Patients with Insomnia Disorder:A Single-Arm,Pre-Post Control ClinicalTrial

Status
Active, not recruiting
Phases
Unknown
Study type
Interventional
Source
ChiCTR
Registry ID
ChiCTR2500108883
Enrollment
Unknown
Registered
2025-09-08
Start date
2025-09-19
Completion date
Unknown
Last updated
2025-09-15

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

Conditions

Insomnia disorder

Interventions

Treatment group:Patients can conduct near-infrared light biodulatory therapy at home by themselves. Each treatment lasts for 30 minutes, and the treatment time is after waking up in the morning and/or

Sponsors

Chinese PLA General Hospital
Lead Sponsor

Eligibility

Sex/Gender
All
Age
18 Years to 65 Years

Inclusion criteria

Inclusion criteria: 1. Meet the diagnostic criteria for chronic insomnia disorder as stipulated in the International Classification of Sleep Disorders (3rd Edition) (ICSD-3), and have a Pittsburgh Sleep Quality Index (PSQI) score of >=7 points; 2. Age: 18 to 65 years old; 3. Right-handed; 4. Those who have been taking sedative-hypnotic drugs stably for more than one month before entering the study, or those who have not taken them for one month and agreed to stop taking them, or those who have never taken the drugs and have not participated in other research projects.

Exclusion criteria

Exclusion criteria: 1. Suffering from other sleep disorders, such as obstructive sleep apnea-hypopnea syndrome, periodic limb movement disorders, restless legs syndrome, etc. 2. Secondary insomnia caused by material dependence, mental disorders or organic diseases; 3. Combined with functional disorders of important organs; 4. Long-term irregular schedules caused by work; 5. Pregnancy or lactation period, claustrophobia and other contraindications for MRI examination; 6. Those who have had lesions in previous cranial examinations.

Design outcomes

Primary

MeasureTime frame
PSQI score;

Countries

China

Contacts

Public ContactZhao Dong

Chinese PLA General Hospital

dong_zhaozhao@126.com+86 133 2117 1015

Outcome results

None listed

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