Eligibility Module
The Eligibility Module contains detailed information about who can participate in the clinical trial. This includes eligibility criteria, age restrictions, gender requirements, healthy volunteer status, and study population descriptions, helping researchers understand who is eligible to participate in the study.
Eligibility Module path is as follows:
Study -> Protocol Section -> Eligibility Module
Eligibility Module
Ignite Creation Date:
2025-12-24 @ 2:15 PM
Ignite Modification Date:
2025-12-24 @ 2:15 PM
NCT ID:
NCT05600595
Eligibility Criteria:
Inclusion Criteria:
① Age 3-14 years old.
② Patients diagnosed as snoring or adenoid hypertrophy in children, tonsil hypertrophy and chronic tonsillitis who are to be treated by adenoidectomy or tonsillectomy or tonsillectomy;
③ Conform to 1. Symptoms: snoring during sleep, breathing with mouth open, some with apnea, restless sleep, and a few children with hearing loss. 2. Fiberoptic nasopharyngoscopy showed adenoids and/or tonsil hypertrophy. 3. No family history of deafness, no history of ototoxic drugs. 4. No external ear and maxillofacial deformity. 5. The tympanic pressure curve is "C" or "B". 6. No suppurative medium.
Auricular inflammation and tympanic membrane perforation; Adhesive otitis media, cholesteatoma of middle ear.
④ Patients' families cooperated well.
⑤ The patient's guardian volunteered to participate in this study and signed the informed consent form.
Exclusion Criteria:
* Middle ear catheterization or puncture was performed at the same time;
* Eustachian atresia or cleft lip and palate; There are craniofacial abnormalities or neuromuscular diseases;
* Benign and malignant tumors of nose or nasopharynx;
* Other middle ear diseases (suppurative otitis media, tympanic membrane perforation; Adhesive otitis media, middle ear cholesteatoma, etc.); ⑤ Those who can't cooperate; ⑥ Previous tonsil and adenoid surgery; ⑦ Upper respiratory tract infection in recent two weeks; ⑧ Any other circumstances that researchers think should be excluded from this study;
Healthy Volunteers:
False
Sex:
ALL
Minimum Age:
3 Years
Maximum Age:
14 Years
Study:
NCT05600595
Study Brief:
Protocol Section:
NCT05600595