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Completed NCT07242001

Laser Acupuncture for Otitis Media With Effusion in Children

Conditions: Otitis Media With Effusion

Sex: All
Ages: 2 Years – 10 Years
Healthy volunteers: No
Phase: NA
Enrollment: 32
Sponsor: Indonesia University

Location: Universitas Indonesia Jakarta Pusat DKI Jakarta

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.

Eligibility Criteria

Inclusion Criteria: * 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. Exclusion Criteria: * 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.

Interested in this study? View the official listing for contact and enrollment details.

View on ClinicalTrials.gov

Source: ClinicalTrials.gov (NCT07242001). StuddyBuddy aggregates publicly available trial information.