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Evaluation of Auricular Acupuncture for the Treatment of Sleep Disorders in Children with Neurodevelopmental Disorders: A Randomized Clinical Trial

Evaluation of Auricular Acupuncture for the Treatment of Sleep Disorders in Children with Neurodevelopmental Disorders: A Randomized Controlled Clinical Trial

Status
Active, not recruiting
Phases
Early Phase 1
Study type
Interventional
Source
TCTR
Registry ID
TCTR20251104002
Enrollment
79
Registered
2025-11-04
Start date
2024-03-01
Completion date
Unknown
Last updated
2026-08-03

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

Conditions

Sleep Disorders Neurodevelopmental Disorders Insomnia Autism Spectrum Disorder Attention Deficit Hyperactivity Disorder Pediatric Sleep Disturbance Auricular Acupuncture Ear Acupressure Complementary Therapies Vaccaria Seeds Children Randomized Controlled Trial Sleep Quality Pediatric Insomnia Acupuncture Points Nonpharmacologic Treatment

Interventions

Auricular acupressure was performed by applying Vaccaria seeds fixed with adhesive tapes at specific auricular points (Shenmen, Heart, Kidney, Subcortex, and Sympathetic). Each seed was pressed gently
Auricular Acupressure,Sham Auricular Acupressure

Sponsors

Da Nang Rehabilitation Hospital
Lead Sponsor

Eligibility

Sex/Gender
All
Age
2 Years to 12 Years

Inclusion criteria

Inclusion criteria: Children aged 2 to 12 years diagnosed with neurodevelopmental disorders such as autism spectrum disorder or attention deficit hyperactivity disorder Diagnosis of sleep disorder according to the International Classification of Sleep Disorders Third Edition ICSD 3 including insomnia or difficulty initiating sleep CSHQ total score greater than 40 at baseline Informed consent obtained from parents or legal guardians

Exclusion criteria

Exclusion criteria: Severe medical comorbidities such as heart renal or hepatic failure Acute surgical conditions requiring intervention Concurrent use of sedative medications during the study period Non adherence to the study protocol Any other condition judged by investigators to interfere with participation or outcome assessment

Design outcomes

Primary

MeasureTime frame
Sleep quality Baseline and week 8 after intervention CSHQ total score

Secondary

MeasureTime frame
Insomnia severity Baseline and week 8 after intervention Pediatric Insomnia Severity Index (PISI)

Countries

Vietnam

Contacts

Public ContactThinh Tran

Da Nang Rehabilitation Hospital

Tienthinhtrandanh@gmail.com0941930685

Outcome results

None listed

Source: TCTR (via WHO ICTRP) · Data processed: Aug 10, 2026