Tonsillar HypertrophyNCT06577051
Evaluation of Eustachian Tube Function With 226 and 1000 Hz Probes in Children Undergoing Tonsillectomy ± Adenoidectomy
An observational study of Tonsillar Hypertrophy and Eustachian Tube Dysfunction, run by Sumeyra DOLUOGLU at 1 site in Turkey (Türkiye).
Trial 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. Read more about this study
- Who is it for?
- Ages 4 to 15 years
- Conditions the study is for
- Tonsillar Hypertrophy, Eustachian Tube Dysfunction, Tympanic Membrane Disorder
- What is being tested?
- Eustachian tube function test with 226 and 1000 Hz probes
- How many people
- 128 participants
- Where
- 1 siteTurkey (Türkiye)
- Study dates
- 20 Aug 2024to 30 Nov 2024
- Phase
- Observational
- 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 4 to 15 years
- All sexes
- No healthy volunteers
- Child
Study population: Pediatric patients aged 4-15 years who underwent tonsillectomy ± adenoidectomy for chronic tonsillitis or sleep breathing disorder without eustachian tube dysfunction were included in the study.
Who may be able to join
- 4-15 years old child patient
- No preoperative tubal dysfunction detected in the patient
- Willingness to participate in the study by the patient and his/her parents
- The patient has no craniofacial anomaly, genetic disorder, cleft palate-lip anomaly
- No bleeding disorder or disease
Who cannot join
- <3 years old, >15 years old paediatric patient
- Tubal dysfunction detected preoperatively
- Not wanting to participate in the study at any stage of the study
- The patient has craniofacial anomaly, genetic disorder, cleft palate-lip anomaly
- Having a bleeding disorder or disease
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Evaluation of Eustachian Tube Function With 226 and 1000 Hz Probes in Children Undergoing Tonsillectomy ± Adenoidectomy Without Tubal Dysfunction
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.
- Conditions
- Tonsillar Hypertrophy, Eustachian Tube Dysfunction, Tympanic Membrane Disorder, Eustachian Tube Dysfunction of Both Ears
- Being tested
- Eustachian tube function test with 226 and 1000 Hz probes
- Keywords
- Eustachian tube, Tubal dysfunction, Tympanometry, High-frequency tympanometry, Eustachian tube dysfunction
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Eustachian tube function test with 226 and 1000 Hz probesDiagnostic test
In children undergoing tonsillectomy ± adenoidectomy without eustachian dysfunction, tympanometry with 226 Hz and 1000 Hz probes, ipsi and contralateral acoustic reflexes with 226 Hz probe, eustachian function test with 226 Hz probe (automatic Williams test) and play audiometry in young children and pure tone audiometry in older children are aimed to control tubal functions in preoperative period, postoperative day 1 and week 2.
| Study group | Role | What they receive |
|---|---|---|
| Children undergoing tonsillectomy ± adenoidectomy without tubal dysfunction | * 4-15 years old child patient
* No preoperative tubal dysfunction detected in the patient
* Willingness to participate in the study by the patient and his/her parents
* The patient has no craniofacial anomaly, genetic disorder, cleft palate-lip anomaly
* No bleeding disorder or disease Receives: Diagnostic Test: Eustachian tube function test with 226 and 1000 Hz probes |
What is being measured
The primary outcome is the main question the study is designed to answer.
Evaluation the functionality of the eustachian tube with odiometric tests
Evaluation the functionality of the eustachian tube, which was presumed to be compromised on the initial post-adenotonsillectomy day, and ascertainment whether it had recuperated by the second week. Tympanometry with 226 and 1000 Hz probes, eustachian function test with 226 Hz probe, ipsi and contralateral acoustic reflexes with 226 Hz probe and pure tone-play audiometry were performed in all patients one day before the operation. All tests were repeated on postoperative day 1 before the patient was discharged. All tests were repeated at the 2nd postoperative week.
Measured: 14 days
Secondary outcomes (1)
Evaluation the functionality of the eustachian tube with tympanometry the 226 Hz and 1000 Hz probes
It was investigated which of the 226 Hz and 1000 Hz probes used in these tests detected earlier recovery findings.
Measured: 21 days
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted29 Aug 2024
- Study start20 Aug 2024
- Primary completion28 Nov 2024
- Study completion30 Nov 2024
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for Tonsillar HypertrophyStudies of the same condition, open and under way.
- 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
- Observational
- Observational model
- Case-control
- Time perspective
- Prospective
- Enrolment
- 128 participants (actual)
Sponsor and investigators
- Lead sponsor
- Sumeyra DOLUOGLU
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor-investigator, Sumeyra DOLUOGLU, Saglik Bilimleri Universitesi
- Investigators
- Sumeyra Doluoglu, MD, Principal investigator, Saglik Bilimleri Universitesi
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06577051
- Sponsor's protocol ID
- SumeyraDoluoglu
- Status last verified
- Apr 2025
- First submitted
- 21 Aug 2024
- Last updated
- 15 Apr 2025
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Undecided
Publications
Doluoglu S, Gazeloglu AZ, Ulger N, Camalan BV, Dagli M. Evaluation of Eustachian tube function with dynamic and static tests in children undergoing adenotonsillectomy: A prospective clinical study. Int J Pediatr Otorhinolaryngol. 2025 Sep;196:112488. doi: 10.1016/j.ijporl.2025.112488. Epub 2025 Jul 14.
PubMed 40663994
Study at a glance
From the registry record, last updated by the sponsor on 15 Apr 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Evaluation of Eustachian Tube Function With 226 and 1000 Hz Probes in Children Undergoing Tonsillectomy ± Adenoidectomy Without Tubal Dysfunction
- ClinicalTrials.gov ID
- NCT06577051
- Acronym / sponsor ID
- SumeyraDoluoglu
- Conditions
- Tonsillar Hypertrophy, Eustachian Tube Dysfunction, Tympanic Membrane Disorder, Eustachian Tube Dysfunction of Both Ears
- Keywords
- Eustachian tube, Tubal dysfunction, Tympanometry, High-frequency tympanometry, Eustachian tube dysfunction
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 128 participants (actual)
- Lead sponsor
- Sumeyra DOLUOGLUUniversity, hospital or other
- Study start
- 20 Aug 2024 (actual)
- Primary completion
- 28 Nov 2024 (actual)
- Study completion
- 30 Nov 2024 (actual)
- First posted
- 29 Aug 2024 (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.
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.
Study design
- Observational model
- Case-control
- Time perspective
- Prospective
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Children undergoing tonsillectomy ± adenoidectomy without tubal dysfunction | – | Diagnostic Test: Eustachian tube function test with 226 and 1000 Hz probes* 4-15 years old child patient * No preoperative tubal dysfunction detected in the patient * Willingness to participate in the study by the patient and his/her parents * The patient has no craniofacial anomaly, genetic disorder, cleft palate-lip anomaly * No bleeding disorder or disease |
Who may qualify
- Ages
- 4 to 15 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child
- Study population
- Pediatric patients aged 4-15 years who underwent tonsillectomy ± adenoidectomy for chronic tonsillitis or sleep breathing disorder without eustachian tube dysfunction were included in the study.
Key inclusion criteria (5 listed)
- 4-15 years old child patient
- No preoperative tubal dysfunction detected in the patient
- Willingness to participate in the study by the patient and his/her parents
- The patient has no craniofacial anomaly, genetic disorder, cleft palate-lip anomaly
- No bleeding disorder or disease
Key exclusion criteria (5 listed)
- <3 years old, >15 years old paediatric patient
- Tubal dysfunction detected preoperatively
- Not wanting to participate in the study at any stage of the study
- The patient has craniofacial anomaly, genetic disorder, cleft palate-lip anomaly
- Having a bleeding disorder or disease
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 |
|---|---|---|
| Eustachian tube function test with 226 and 1000 Hz probesIn children undergoing tonsillectomy ± adenoidectomy without eustachian dysfunction, tympanometry with 226 Hz and 1000 Hz probes, ipsi and contralateral acoustic reflexes with 226 Hz probe, eustachian function test with 226 Hz probe (automatic Williams test) and play audiometry in young children and pure tone audiometry in older children are aimed to control tubal functions in preoperative period, postoperative day 1 and week 2. | Diagnostic test | Children undergoing tonsillectomy ± adenoidectomy without tubal dysfunction |
Primary outcome
Evaluation the functionality of the eustachian tube with odiometric tests
Time frame: 14 days
Evaluation the functionality of the eustachian tube, which was presumed to be compromised on the initial post-adenotonsillectomy day, and ascertainment whether it had recuperated by the second week. Tympanometry with 226 and 1000 Hz probes, eustachian function test with 226 Hz probe, ipsi and contralateral acoustic reflexes with 226 Hz probe and pure tone-play audiometry were performed in all patients one day before the operation. All tests were repeated on postoperative day 1 before the patient was discharged. All tests were repeated at the 2nd postoperative week.
1 secondary outcome
Evaluation the functionality of the eustachian tube with tympanometry the 226 Hz and 1000 Hz probes
Time frame: 21 days
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 15 Apr 2025.
- Derived from this study: PubMed 40663994Doluoglu S, Gazeloglu AZ, Ulger N, Camalan BV, Dagli M. Evaluation of Eustachian tube function with dynamic and static tests in children undergoing adenotonsillectomy: A prospective clinical study. Int J Pediatr Otorhinolaryngol. 2025 Sep;196:112488. doi: 10.1016/j.ijporl.2025.112488. Epub 2025 Jul 14.
- Individual participant dataSharing planned: Undecided
Related trials for Tonsillar Hypertrophy
Recruiting
Photobiomodulation for Pediatric Hypertrophic Tonsils
Pediatric Sleep Apnea, Obstructive Sleep Apnea
Not yet recruiting
Full-wrap Versus Conventional Suspension for Reducing Soft Palate Injury Rate in Transoral Surgery
Adenoid Hypertrophy, Tonsillar Hypertrophy
Not yet recruiting
Randomized Clinical Trial for Tonsil Surgery in Adults With Obstructive Sleep Apnea and Enlarged Tonsils
Sleep Apnea, Obstructives, Tonsil Hypertrophy
Recruiting
Lateral Pharyngoplasty Outcomes in Children Undergoing Tonsillectomy
Sleep-Disordered Breathing, Sleep Apnea Syndromes in Children
Not yet recruitingObservational study
Evaluation of the Effects of Adenoidectomy and Adenotonsillectomy on Voice in Children
Adenoid Hypertrophy, Tonsillar Hypertrophy
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.
Sumeyra Doluoglu, MD principal investigator
Saglik Bilimleri Universitesi
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Tonsillar Hypertrophy and Eustachian Tube Dysfunction, run by Sumeyra DOLUOGLU at 1 site in Turkey (Türkiye).
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 5 inclusion and 5 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 15 Apr 2025. 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 Turkey (Türkiye). 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. 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?
Evaluation the functionality of the eustachian tube with odiometric tests (time frame: 14 days). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT06577051, which also lists 1 linked publication.
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 15 Apr 2025.