Laser Acupuncture for Otitis Media With Effusion in Children

NCT07242001 | Recruiting

• 1 other identifier: 25-09-1474
• Study Type: interventional
• Target: 32
• Locations: 1 country
• Sites: 1

Brief Summary

The goal of this clinical trial is to learn if laser acupuncture (LA) can improve middle ear function and reduce the recurrence of Otitis Media with Effusion (OME) in children. The main questions it aims to answer are: Does LA, when combined with standard treatment (decongestants), improve middle ear function as measured by tympanometry immediately after the 2-week intervention? Does LA, when combined with standard treatment, reduce the recurrence rate of OME as monitored over a 1-month period after the intervention? What is the safety profile of LA in this population, as measured by the incidence of adverse events? Researchers will compare active LA to sham LA (a placebo procedure with an inactive device) to determine if LA leads to meaningful improvements in children with OME. Participants will: Complete an initial assessment using tympanometry to confirm the diagnosis. Receive four sessions of either active LA or sham LA over a 2-week period. Complete a final assessment using tympanometry after the final session. Participate in a 1-month follow-up period with weekly monitoring for recurrence.

Conditions

Otitis Media With Effusion

Outcome Measures

Primary Outcomes (1)

• Change in Tympanogram Results

  Improvement in middle ear function will be assessed using tympanometry. The outcome is measured as the proportion of participants whose tympanogram curve change from Type B (indicating effusion) to Type A (normal).

  Baseline and immediately after the final (4th) therapy session at 2 weeks.

Secondary Outcomes (3)

• Recurrence Rate of OME

  From the end of the intervention over a 1-month follow-up period.

• Time to First Recurrence

  From the end of the intervention over a 1-month follow-up period.

• Incidence of Adverse Events

  At the end of each of the four acupuncture therapy sessions.

Study Arms (2)

Intervention Group

EXPERIMENTAL

Active laser acupuncture and standard decongestants.

Device: Laser Acupuncture

Control Group

SHAM COMPARATOR

Sham laser acupuncture and standard decongestants.

Device: Sham Laser Acupuncture

Interventions

Sham Laser Acupuncture DEVICE

Sham Laser Acupuncture involves placing the applicator of an inactive laser device onto the same acupoints (SI19, TE17, TE5, and LI4) for the same duration as the active group. The device is turned on, but the start button is not pressed, so no laser energy is emitted. All procedures, including aseptic preparation, timing, and handling of the device, are performed identically to the intervention group to maintain blinding. Participants will wear ear covers and the device's LCD panel will be covered. Participants continue their routine decongestant therapy.

Control Group

Laser Acupuncture DEVICE

Laser Acupuncture is performed for 40 seconds per point at acupoints SI19, TE17, TE5, and LI4 using a low-level laser device (785 nm, 50 mW, delivering an energy density of 12.73 J/cm²). The device is activated to emit laser energy. Standard aseptic procedures are followed. The laser applicator is held perpendicular to the skin without pressure. Participants continue their routine decongestant therapy.

Intervention Group

Eligibility Criteria

• Age: 2 Years - 10 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Child (0-17)

You may qualify if:

• Children aged 2-10 years, both male and female.
• Diagnosed with OME with a Type B tympanogram curve, either unilateral or bilateral.
• No acute ear infection within the last 2 weeks.
• Willingness to participate in the study until completion and signed informed consent from a parent or legal guardian.

You may not qualify if:

• History of tympanic membrane perforation or previous ear surgery.
• Presence of severe OME complications, such as permanent hearing loss, tympanosclerosis, or cholesteatoma.
• Underwent laser acupuncture therapy for OME within the last three months.
• History of unstable systemic disease or other medical conditions that could interfere with the study, such as a history of uncontrolled seizures or epilepsy, a current high fever \>38°C, or malignancy/cancer in the ENT system.
• Presence of a mental disorder, inability to communicate well, or being uncooperative.
• Presence of wounds or skin lesions at the intended acupuncture point irradiation sites.

Sponsors & Collaborators

• Indonesia University: lead

Study Sites (1)

Universitas Indonesia

Jakarta Pusat, DKI Jakarta, 10430, Indonesia

RECRUITING

MeSH Terms

Conditions

Otitis Media with Effusion

Condition Hierarchy (Ancestors)

Otitis Media; Otitis; Ear Diseases; Otorhinolaryngologic Diseases

Study Officials

• KPEK FKUI-RSCM

  The Health Research Ethics Commitee - Faculty of Medicine Universitas Indonesia and Dr. Cipto Mangunkusumo National Hospital

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Agitha M Putri

CONTACT

082114568788; agitha.melita@ui.ac.id

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: DOUBLE
• Who Masked: PARTICIPANT, OUTCOMES ASSESSOR
• Masking Details: Blinding will be applied to participants and outcome assessors. Group allocation will not be disclosed to them to minimize assessment bias.
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Principal Investigator

Model Details: The treatment group receiving active laser acupuncture and standard decongestants while the control group receiving sham laser acupuncture and standard decongestants.

Study Record Dates

• First Submitted: November 17, 2025
• First Posted: November 21, 2025
• Study Start: December 29, 2025
• Primary Completion (Estimated): May 31, 2026
• Study Completion (Estimated): June 30, 2026
• Last Updated: February 5, 2026

Record last verified: 2026-02

Data Sharing

• IPD Sharing: Will not share

Locations

ID (1)