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Randomised controlled trials of low-intensity laser versus acupuncture for insomnia

Randomised controlled trials of low-intensity laser versus acupuncture for insomnia

Status
Active, not recruiting
Phases
Unknown
Study type
Interventional
Source
ITMCTR
Registry ID
ITMCTR2025000977
Enrollment
Unknown
Registered
2025-05-13
Start date
2025-06-01
Completion date
Unknown
Last updated
2025-05-26

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

Conditions

insomnia

Interventions

experimental group:Low-intensity laser acupoint irradiation

Sponsors

Guangdong Hospital of Traditional Chinese Medicine
Lead Sponsor

Eligibility

Sex/Gender
All
Age
18 Years to 65 Years

Inclusion criteria

Inclusion criteria: (1) Age = 18 years and = 65 years; gender is not limited;(2) Meets the diagnostic criteria for chronic insomnia disorder according to DSM-5;(3) Insomnia Severity Index (ISI) score = 8 points;(4) Signed informed consent form and committed to completing the research process.

Exclusion criteria

Exclusion criteria: (1) Individuals preparing for pregnancy who are pregnant breastfeeding or need to sleep with children;(2) Based on medical history and inquiry doctors confirm secondary insomnia disorders caused by other diseases such as: localized pain high risk of sleep apnea (STOP-Bang questionnaire for obstructive sleep apnea =3 points; Epworth Sleepiness Scale =10 points) restless legs syndrome circadian rhythm disorders acute and chronic heart failure chronic obstructive pulmonary disease acute and chronic bronchitis etc.;(3) Patients diagnosed with moderate or severe depression according to the Patient Health Questionnaire-9 (PHQ-9) (total score =10);(4) Patients diagnosed with moderate or severe anxiety according to the Generalized Anxiety Disorder 7-item scale (GAD-7) (total score =10);(5) Patients with severe insomnia as determined by the Insomnia Severity Index (ISI) (total score =22);(6) Patients who based on medical history and inquiry are confirmed by a doctor as needing to be managed according to disease management methods;(7) Patients with photosensitivity (laser group);(8) Needle phobia or psychological disorders (acupuncture group);(9) Patients who have received or are currently receiving other drug interventions CBT-I rTMS or acupuncture treatment in the past two weeks(10) Patients who cannot or are unwilling to sign the informed consent form and cooperate in completing the study.

Design outcomes

Primary

MeasureTime frame
Insomnia Severity Index;

Secondary

MeasureTime frame
Bio-electromagnetic wave resonance detector;Patient Health QuestionnairePHQ-9;Heart Rate Variability Detection;Pittsburgh Sleep Quality IndexPSQI;Fatigue severity scaleFSS;Generalized Anxiety Disorder Scale;

Countries

China

Contacts

Public ContactYanzhao Lin

No.111 Dade Road Yuexiu District Guangzhou City Guangdong Province China

linyanzhao@163.com13535590963

Outcome results

None listed

Source: ITMCTR (via WHO ICTRP) · Data processed: Jun 3, 2026