Otitis Media With EffusionNCT07242001
Laser Acupuncture for Otitis Media With Effusion in Children
A study testing Laser Acupuncture in people with Otitis Media With Effusion, run by Universitas Indonesia at 1 site in Indonesia.
Trial 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… Read more about this study
- Who is it for?
- Ages 2 to 10 years
- Conditions the study is for
- Otitis Media With Effusion
- What is being tested?
- Laser Acupuncture
- Type of treatment
- Medical device
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 32 participants
- Where
- 1 siteIndonesia
- Study dates
- 29 Dec 2025to 22 Apr 2026
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 2 to 10 years
- All sexes
- No healthy volunteers
- Child
Who may be able to join
- 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.
Who cannot join
- 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.
Trial locations and contacts
1 site in 1 country.
About this study
Official title: The Effectiveness of Laser Acupuncture in the Management of Otitis Media With Effusion in Children
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.
Read more
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.
Read the detailed description
This is a double-blind, randomized controlled trial designed to assess the effectiveness and safety of laser acupuncture as an adjunctive therapy for Otitis Media with Effusion (OME) in children. A total of 32 participants aged 2-10 years will be randomly assigned to either a treatment group (receiving active laser acupuncture and standard decongestants) or a control group (receiving sham laser acupuncture and standard decongestants). The intervention consists of four sessions over two weeks. The primary outcome is the improvement of middle ear function, measured by a change in tympanometry results from Type B to Type A. Secondary outcomes include the rate of OME recurrence at one month and the incidence of adverse events during the therapy period. This study will provide evidence on whether laser acupuncture is a beneficial, non-invasive treatment option for this common pediatric condition.
- Conditions
- Otitis Media With Effusion
- Being tested
- Laser Acupuncture, Sham Laser Acupuncture
- Medical subject headings
- Otitis Media with Effusion
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Laser AcupunctureDevice
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.
Sham Laser AcupunctureDevice
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.
| Study group | Role | What they receive |
|---|---|---|
| Intervention Group | Experimental | Active laser acupuncture and standard decongestants. Receives: Device: Laser Acupuncture |
| Control Group | Sham comparator | Sham laser acupuncture and standard decongestants. Receives: Device: Sham Laser Acupuncture |
What is being measured
The primary outcome is the main question the study is designed to answer.
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).
Measured: Baseline and immediately after the final (4th) therapy session at 2 weeks.
Secondary outcomes (3)
Recurrence Rate of OME
The number of participants who experience a recurrence of OME symptoms after the intervention period will be recorded, assessed via weekly monitoring.
Measured: From the end of the intervention over a 1-month follow-up period.
Time to First Recurrence
ime (in days/weeks) from the end of the intervention to the first documented recurrence of OME will be measured.
Measured: From the end of the intervention over a 1-month follow-up period.
Incidence of Adverse Events
The total number, type, and severity of adverse events reported by participants will be documented throughout the therapy period.
Measured: At the end of each of the four acupuncture therapy sessions.
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted21 Nov 2025
- Study start29 Dec 2025
- Primary completion26 Mar 2026
- Study completion22 Apr 2026
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Otitis Media With EffusionStudies of the same condition, open and under way.
- More trials run by Universitas IndonesiaThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Model description
- The treatment group receiving active laser acupuncture and standard decongestants while the control group receiving sham laser acupuncture and standard decongestants.
- Masking
- Double blind
- Who is masked
- Participant, Outcomes assessor
- Enrolment
- 32 participants (actual)
Sponsor and investigators
- Lead sponsor
- Universitas Indonesia
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Agitha Melita Putri, Universitas Indonesia
- Investigators
- KPEK FKUI-RSCM, Principal investigator, The Health Research Ethics Commitee - Faculty of Medicine Universitas Indonesia and Dr. Cipto Mangunkusumo National Hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07242001
- Sponsor's protocol ID
- 25-09-1474
- Status last verified
- Jun 2026
- First submitted
- 17 Nov 2025
- Last updated
- 4 Jun 2026
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 4 Jun 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- The Effectiveness of Laser Acupuncture in the Management of Otitis Media With Effusion in Children
- ClinicalTrials.gov ID
- NCT07242001
- Acronym / sponsor ID
- 25-09-1474
- Conditions
- Otitis Media With Effusion
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 32 participants (actual)
- Lead sponsor
- Universitas IndonesiaUniversity, hospital or other
- Study start
- 29 Dec 2025 (actual)
- Primary completion
- 26 Mar 2026 (actual)
- Study completion
- 22 Apr 2026 (actual)
- First posted
- 21 Nov 2025 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Detailed description
This is a double-blind, randomized controlled trial designed to assess the effectiveness and safety of laser acupuncture as an adjunctive therapy for Otitis Media with Effusion (OME) in children. A total of 32 participants aged 2-10 years will be randomly assigned to either a treatment group (receiving active laser acupuncture and standard decongestants) or a control group (receiving sham laser acupuncture and standard decongestants). The intervention consists of four sessions over two weeks. The primary outcome is the improvement of middle ear function, measured by a change in tympanometry results from Type B to Type A. Secondary outcomes include the rate of OME recurrence at one month and the incidence of adverse events during the therapy period. This study will provide evidence on whether laser acupuncture is a beneficial, non-invasive treatment option for this common pediatric condition.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind (participant, outcomes assessor)
- Number of arms
- 2
- Model description
- The treatment group receiving active laser acupuncture and standard decongestants while the control group receiving sham laser acupuncture and standard decongestants.
| Arm | Type | Receives |
|---|---|---|
| Intervention Group | Experimental | Device: Laser AcupunctureActive laser acupuncture and standard decongestants. |
| Control Group | Sham comparator | Device: Sham Laser AcupunctureSham laser acupuncture and standard decongestants. |
Who may qualify
- Ages
- 2 to 10 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child
Key inclusion criteria (4 listed)
- 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.
Key exclusion criteria (6 listed)
- 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.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Laser AcupunctureLaser 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. | Device | Intervention Group |
| Sham Laser AcupunctureSham 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. | Device | Control Group |
Primary outcome
Change in Tympanogram Results
Time frame: Baseline and immediately after the final (4th) therapy session at 2 weeks.
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).
3 secondary outcomes
Recurrence Rate of OME
Time frame: From the end of the intervention over a 1-month follow-up period.
Time to First Recurrence
Time frame: From the end of the intervention over a 1-month follow-up period.
Incidence of Adverse Events
Time frame: At the end of each of the four acupuncture therapy sessions.
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 4 Jun 2026.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
KPEK FKUI-RSCM principal investigator
The Health Research Ethics Commitee - Faculty of Medicine Universitas Indonesia and Dr. Cipto Mangunkusumo National Hospital
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Laser Acupuncture in people with Otitis Media With Effusion, run by Universitas Indonesia at 1 site in Indonesia.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 4 inclusion and 6 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 4 Jun 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Indonesia. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. Some participants in this study may receive a placebo. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Change in Tympanogram Results (time frame: Baseline and immediately after the final (4th) therapy session at 2 weeks.). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 4 Jun 2026.