Ignite Creation Date:
2025-12-24 @ 11:51 PM
Ignite Modification Date:
2026-01-01 @ 8:47 PM
Study NCT ID:
NCT06577051
Status:
COMPLETED
Last Update Posted:
2025-04-15
First Post:
2024-08-21
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Evaluation of Eustachian Tube Function With 226 and 1000 Hz Probes in Children Undergoing Tonsillectomy ± Adenoidectomy
Sponsor:
Sumeyra DOLUOGLU
Organization:
Study Overview
Official Title:
Evaluation of Eustachian Tube Function With 226 and 1000 Hz Probes in Children Undergoing Tonsillectomy ± Adenoidectomy Without Tubal Dysfunction
Status:
COMPLETED
Status Verified Date:
2025-04
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
Not Stopped
Has Expanded Access:
False
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
None
Brief Summary:
In children undergoing tonsillectomy ± adenoidectomy without eustachian dysfunction, the objective is to control tubal functions with tympanometry utilising probes at 226 Hz and 1000 Hz, as well as measuring the ipsilateral and contralateral acoustic reflexes with a 226 Hz probe. An eustachian function test with a 226 Hz probe (automatic Williams test) and play audiometry are to be conducted on young children, while pure tone audiometry is to be conducted on older children, in the preoperative period, on the first day after surgery and in the second week after surgery. The primary objective is to ascertain whether the tubal functions, which are hypothesised to be impaired on the first day, return at the latest in the second week, with all tests evaluating the eustachian tube both directly and indirectly. The secondary objective is to determine whether this recovery occurs earlier with the 226 Hz probe or the 1000 Hz probe.
Detailed Description:
None
Study Oversight
Has Oversight DMC:
False
Is a FDA Regulated Drug?:
False
Is a FDA Regulated Device?:
False
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
None
Is an FDA AA801 Violation?: