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Protocol for the clinical trial of the effectiveness of Eustachian tube inflation and atomization in the treatment of secretory otitis media

Protocol for the clinical trial of the effectiveness of Eustachian tube inflation and atomization in the treatment of secretory otitis media

Status
Recruiting
Phases
Unknown
Study type
Interventional
Source
ChiCTR
Registry ID
ChiCTR2500103384
Enrollment
Unknown
Registered
2025-05-28
Start date
2024-03-20
Completion date
Unknown
Last updated
2025-06-02

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

Conditions

Otitis media with effusion

Interventions

Eustachian tube inflation atomization group (Children group):The treatment was given twice a day for 5 days, or stopped because of intolerance (pain or acute upper respiratory tract infection), if it
Eustachian tube inflation atomization group (Adult group):The treatment was given twice a day for 5 days, or stopped because of intolerance (pain or acute upper respiratory tract infection), if it rec
Eustachian tube inflation group (Children group):The Eustachian tube inflation group used an electric Eustachian tube inflation device. 2 times a day, 10 minutes a time
The duration of inflation was up to 12 weeks and either stopped because of intolerance (pain or acute upper respiratory tract infection) or healed (healed was defined as bone-air gap =5dB on pure tone
Eustachian tube inflation group(Adult group):The Eustachian tube inflation group used an electric Eustachian tube inflation device. 2 times a day, 10 minutes a time
Drug group (Children group):Mometasone furoate nasal spray (Nesonar, 60 pug /140

Sponsors

Shandong Second People's Hospital
Lead Sponsor

Eligibility

Sex/Gender
All
Age
4 Years to 70 Years

Inclusion criteria

Inclusion criteria: 1. good general health and clear consciousness; 2. provide signed and dated informed consent; 3. express willingness to comply with all study procedures and availability during the study period; 4. Age: children (4-12 years old), adults (18-70 years old), both sexes; 5. Course of disease: the duration of onset was within 4 weeks; 6. hearing loss, pure tone audiometry showed that the air conduction hearing level (500Hz, 1kHz, 2kHz, 4kHz average threshold) decreased by more than 20dB; Or tympanic effusion in otoendoscopy examination; 7. Tympanogram showed type B, C1 or C2;

Exclusion criteria

Exclusion criteria: 1. recent nasal, sinusitis or upper respiratory tract infection, and retrograde ear infection; 2. patients with congenital or secondary Eustachian tube atresia; 3. patients with nasopharyngeal tumors, nasopharyngeal carcinoma and systemic malignant tumors; 4. patients with adenoid hypertrophy; 5. patients with patulous Eustachian tube; 6. recent nasal or nasopharynx bleeding; 7. with cleft lip and palate and unable to seal the nasopharyngeal cavity; 8. vocal fold spasm or paralysis; 9. patients with recent middle ear surgery; 10. during pregnancy or lactation; 11. combined with other diseases, antibiotics or hormone drugs should be taken.

Design outcomes

Primary

MeasureTime frame
hearing result;

Secondary

MeasureTime frame
Effusion in the tympanic cavity;Eustachian tube function;Degree of ear fullness;

Countries

China

Contacts

Public ContactLi Li

Shandong Second People's Hospital

honey-ly@126.com+86 151 6886 3996

Outcome results

None listed

Source: ChiCTR (via WHO ICTRP) · Data processed: Feb 4, 2026