Adenoid HypertrophyNCT07399041
Evaluation of the Effects of Adenoidectomy and Adenotonsillectomy on Voice in Children
An observational study of Adenoid Hypertrophy and Tonsillar Hypertrophy, run by Gaziosmanpasa Research and Education Hospital at 1 site in Turkey (Türkiye).
Trial summary
This prospective study aims to evaluate the effects of adenoidectomy and adenotonsillectomy on voice and speech functions in children. Changes in voice quality and resonance may occur after the removal of adenoid and tonsillar tissues, particularly in pediatric patients with enlarged adenoids or tonsils. Read more about this study
- Who is it for?
- Ages 4 to 13 years
- Conditions the study is for
- Adenoid Hypertrophy, Tonsillar Hypertrophy, Voice Disorders in Children
- How many people
- 36 participants
- Where
- 1 siteTurkey (Türkiye)
- Study dates
- Feb 2026to Aug 2026
- Phase
- Observational
- Are there results?
- Not yet: the study is under way
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 13 years
- All sexes
- No healthy volunteers
- Child
Study population: This study includes children aged 4-13 years who are scheduled for primary adenoidectomy or adenotonsillectomy. The aim is to evaluate the effects of these surgical procedures on voice and speech function, using both objective acoustic measurements and validated pediatric voice-related quality of life questionnaires.
Who may be able to join
- Aged 4-13 years
- Scheduled for primary adenoidectomy or adenotonsillectomy
Who cannot join
- Does not meet inclusion criteria
- Refuses to participate in the study
- Diagnosis of vocal cord disorders
- History of vocal cord surgery
- History of cleft palate or cleft lip
- Hearing loss requiring a hearing aid
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- Chronic diseases that may impair wound healing, including: hypertension, diabetes mellitus, immunodeficiency, autoimmune diseases, rheumatologic diseases, connective tissue disorders, renal failure, liver failure, chronic heart disease
- Known bleeding diathesis
- Use of anticoagulant or antiplatelet drugs
- Upper respiratory tract infection within the last 2 weeks
- Patients undergoing revision adenoidectomy
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
Turkey (Türkiye)1 site
Gaziosmanpaşa Training and Research Hospital
Istanbul, 34245
DERYA CEBECİ, MD, +90 536 243 20 20, drderyacebeci@gmail.com
About this study
Official title: A Prospective Single-Center Study Evaluating the Effects of Adenoidectomy and Adenotonsillectomy on Voice and Speech Functions in Children
This prospective study aims to evaluate the effects of adenoidectomy and adenotonsillectomy on voice and speech functions in children. Changes in voice quality and resonance may occur after the removal of adenoid and tonsillar tissues, particularly in pediatric patients with enlarged adenoids or tonsils.
Objective voice assessments, including acoustic, aerodynamic, and nasalance measurements, as well as subjective voice-related quality of life questionnaires, will be performed before surgery and at the first and third months after surgery. The results of this study are expected to help clinicians better inform families about possible voice changes following adenoidectomy and adenotonsillectomy procedures.
Read the detailed description
This is a prospective, single-center observational study designed to evaluate the effects of adenoidectomy and adenotonsillectomy on voice and speech functions in pediatric patients.
A minimum of 36 children aged between 4 and 13 years who are scheduled for primary adenoidectomy or adenotonsillectomy will be included in the study. Written informed consent will be obtained from the parents or legal guardians of all participants prior to enrollment. All patients will undergo routine otolaryngological examination.
Voice recordings will be obtained in a sound-isolated room one day before surgery and at the first and third postoperative months. Recordings will be performed using an AKG P5-S dynamic microphone (AKG®, Vienna, Austria) and a Behringer UMC22 audio interface (Behringer®, Willich, Germany). The microphone will be positioned at approximately a 90-degree angle and 10 cm from the mouth while the patient is seated.
Participants will be instructed to sustain the vowel /a/ at a comfortable pitch and loudness following deep inspiration, repeated three times. The longest sustained phonation will be recorded as the maximum phonation time and used as an aerodynamic parameter.
Acoustic analysis will be performed using Praat software (Version 6.1.39; Paul Boersma and David Weenink, University of Amsterdam). Sustained vowel samples of 3-5 seconds will be analyzed to obtain fundamental frequency (F0), jitter, shimmer, and harmonics-to-noise ratio (HNR) values.
Nasalance measurements will be conducted using a Plex device and a dynamic microphone to evaluate nasal resonance and determine whether resonance values fall within normal limits.
All voice recordings will be captured using Audacity software and analyzed using Praat. Subjective voice assessment will be performed using the Pediatric Voice Handicap Index and the Pediatric Voice-Related Quality of Life questionnaires, both of which have been validated in Turkish. These questionnaires will be administered preoperatively and at the first and third postoperative months.
The study aims to provide objective and subjective data regarding voice changes following adenoidectomy and adenotonsillectomy and to support preoperative counseling of families regarding potential postoperative voice outcomes.
- Keywords
- Adenoidectomy, Adenotonsillectomy, Pediatric Voice, Nasalance, praat
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
| Study group | Role | What they receive |
|---|---|---|
| Children Undergoing Adenoidectomy or Adenotonsillectomy | Children aged 4-13 years scheduled for routine adenoidectomy or adenotonsillectomy. Participants are followed prospectively to evaluate changes in voice and speech parameters before surgery and at postoperative 1st and 3rd months. |
What is being measured
The primary outcome is the main question the study is designed to answer.
Change in Fundamental Frequency (F0)
Fundamental frequency (F0), expressed in Hertz (Hz), will be measured using objective acoustic voice analysis with Praat software. Measurements will be obtained from sustained vowel /a/ recordings and compared between preoperative and postoperative evaluations.
Measured: Preoperative, 1 month postoperative, and 3 months postoperative
Change in Jitter Percentage
Jitter, expressed as a percentage (%), will be measured from sustained vowel /a/ recordings using Praat software. Preoperative jitter values will be compared with postoperative measurements at the 1st and 3rd months to assess changes in frequency stability after surgery.
Measured: Preoperative, 1 month postoperative, and 3 months postoperative
Change in Shimmer Percentage
Shimmer, expressed as a percentage (%), will be measured from sustained vowel /a/ recordings using Praat software. Measurements obtained preoperatively will be compared with postoperative values at the 1st and 3rd months to evaluate changes in amplitude stability following surgery.
Measured: Preoperative, 1 month postoperative, and 3 months postoperative
Change in Harmonics-to-Noise Ratio (HNR)
Harmonics-to-noise ratio (HNR), measured in decibels (dB), will be obtained from sustained vowel /a/ recordings using Praat software. Preoperative and postoperative (1st and 3rd months) values will be compared to assess changes in voice signal quality after surgery.
Measured: Preoperative, 1 month postoperative, and 3 months postoperative
Secondary outcomes (3)
Change in Nasalance Scores After Surgery
Nasalance will be measured using a nasalance measurement system with a plex device and dynamic microphone. Nasalance scores are expressed as percentages ranging from 0% to 100%, with higher scores indicating increased nasal resonance. Preoperative and postoperative measurements will be compared.
Measured: Preoperative, 1 month postoperative, and 3 months postoperative
Change in Pediatric Voice Handicap Index Scores
Subjective voice outcomes will be assessed using the Pediatric Voice Handicap Index (PVHI). The total score ranges from 0 to 92, with higher scores indicating greater perceived voice-related handicap. The validated Turkish version of the questionnaire will be administered preoperatively and postoperatively.
Measured: Preoperative, 1 month postoperative, and 3 months postoperative
Change in Pediatric Voice-Related Quality of Life Scores
Voice-related quality of life will be evaluated using the Pediatric Voice-Related Quality of Life (PVRQOL) questionnaire. Scores range from 0 to 100, with higher scores indicating better voice-related quality of life. The validated Turkish version will be used.
Measured: Preoperative, 1 month postoperative, and 3 months postoperative
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted10 Feb 2026
- Study startFeb 2026 (estimated)
- Primary completionJul 2026 (estimated)
- Study completionAug 2026 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (3)Papers the sponsor has linked to this study.
- Other trials for Adenoid 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
- Cohort
- Time perspective
- Prospective
- Enrolment
- 36 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Gaziosmanpasa Research and Education Hospital
- Sponsor type
- Other government
- Responsible party
- Sponsor
- Investigators
- DERYA CEBECİ, MD, Principal investigator, Gaziosmanpaşa Training and Research Hospital, Department of Otolaryngology
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07399041
- Sponsor's protocol ID
- ENT-PROS-AD-AT-2026
- Status last verified
- Feb 2026
- First submitted
- 23 Jan 2026
- Last updated
- 10 Feb 2026
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No: Individual participant data (IPD) from this study will not be shared outside of the research team due to the sensitive nature of pediatric patient data and privacy considerations.
Publications
Kara M, Ozturk K, Ozer B. An evaluation of the effects of adenoidectomy on voice and speech function in children. Kulak Burun Bogaz Ihtis Derg. 2013 Jul-Aug;23(4):225-31. doi: 10.5606/kbbihtisas.2013.09476.
PubMed 23834133Adenotonsillektominin Akustik, Algısal ve Aerodinamik Ses Parametrelerine Etkisi. Beyhan Yılmaz, Engin Sengul, Musa Özbay, Salih Bakır. Dicle Tıp Dergisi /Dicle Medical Journal 2016; 43 (2): 333-338. doi: 10.5798/diclemedj.0921.2016.02.0691
Inja RR, Paul RR, Varghese L, Santosh S, Sebastian T, Mathews SS. Voice Change Following Adenotonsillectomy in Pediatric Population: Myth or Reality?-A Pilot Study. Indian J Otolaryngol Head Neck Surg. 2019 Oct;71(Suppl 1):574-579. doi: 10.1007/s12070-018-1412-6. Epub 2018 Jun 4.
PubMed 31742023
Study at a glance
From the registry record, last updated by the sponsor on 10 Feb 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Prospective Single-Center Study Evaluating the Effects of Adenoidectomy and Adenotonsillectomy on Voice and Speech Functions in Children
- ClinicalTrials.gov ID
- NCT07399041
- Acronym / sponsor ID
- ENT-PROS-AD-AT-2026
- Keywords
- Adenoidectomy, Adenotonsillectomy, Pediatric Voice, Nasalance, praat
- Study type
- Observational
- Recruitment status
- Not yet recruiting
- Enrolment
- 36 participants (estimated)
- Lead sponsor
- Gaziosmanpasa Research and Education HospitalOther government
- Study start
- Feb 2026 (estimated)
- Primary completion
- Jul 2026 (estimated)
- Study completion
- Aug 2026 (estimated)
- First posted
- 10 Feb 2026 (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.
This prospective study aims to evaluate the effects of adenoidectomy and adenotonsillectomy on voice and speech functions in children. Changes in voice quality and resonance may occur after the removal of adenoid and tonsillar tissues, particularly in pediatric patients with enlarged adenoids or tonsils.
Objective voice assessments, including acoustic, aerodynamic, and nasalance measurements, as well as subjective voice-related quality of life questionnaires, will be performed before surgery and at the first and third months after surgery. The results of this study are expected to help clinicians better inform families about possible voice changes following adenoidectomy and adenotonsillectomy procedures.
Detailed description
This is a prospective, single-center observational study designed to evaluate the effects of adenoidectomy and adenotonsillectomy on voice and speech functions in pediatric patients.
A minimum of 36 children aged between 4 and 13 years who are scheduled for primary adenoidectomy or adenotonsillectomy will be included in the study. Written informed consent will be obtained from the parents or legal guardians of all participants prior to enrollment. All patients will undergo routine otolaryngological examination.
Voice recordings will be obtained in a sound-isolated room one day before surgery and at the first and third postoperative months. Recordings will be performed using an AKG P5-S dynamic microphone (AKG®, Vienna, Austria) and a Behringer UMC22 audio interface (Behringer®, Willich, Germany). The microphone will be positioned at approximately a 90-degree angle and 10 cm from the mouth while the patient is seated.
Participants will be instructed to sustain the vowel /a/ at a comfortable pitch and loudness following deep inspiration, repeated three times. The longest sustained phonation will be recorded as the maximum phonation time and used as an aerodynamic parameter.
Acoustic analysis will be performed using Praat software (Version 6.1.39; Paul Boersma and David Weenink, University of Amsterdam). Sustained vowel samples of 3-5 seconds will be analyzed to obtain fundamental frequency (F0), jitter, shimmer, and harmonics-to-noise ratio (HNR) values.
Nasalance measurements will be conducted using a Plex device and a dynamic microphone to evaluate nasal resonance and determine whether resonance values fall within normal limits.
All voice recordings will be captured using Audacity software and analyzed using Praat. Subjective voice assessment will be performed using the Pediatric Voice Handicap Index and the Pediatric Voice-Related Quality of Life questionnaires, both of which have been validated in Turkish. These questionnaires will be administered preoperatively and at the first and third postoperative months.
The study aims to provide objective and subjective data regarding voice changes following adenoidectomy and adenotonsillectomy and to support preoperative counseling of families regarding potential postoperative voice outcomes.
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Children Undergoing Adenoidectomy or Adenotonsillectomy | – | –Children aged 4-13 years scheduled for routine adenoidectomy or adenotonsillectomy. Participants are followed prospectively to evaluate changes in voice and speech parameters before surgery and at postoperative 1st and 3rd months. |
Who may qualify
- Ages
- 4 to 13 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child
- Study population
- This study includes children aged 4-13 years who are scheduled for primary adenoidectomy or adenotonsillectomy. The aim is to evaluate the effects of these surgical procedures on voice and speech function, using both objective acoustic measurements and validated pediatric voice-related quality of life questionnaires.
Key inclusion criteria (2 listed)
- Aged 4-13 years
- Scheduled for primary adenoidectomy or adenotonsillectomy
Key exclusion criteria (11 listed)
- Does not meet inclusion criteria
- Refuses to participate in the study
- Diagnosis of vocal cord disorders
- History of vocal cord surgery
- History of cleft palate or cleft lip
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Primary outcome
Change in Fundamental Frequency (F0)
Time frame: Preoperative, 1 month postoperative, and 3 months postoperative
Fundamental frequency (F0), expressed in Hertz (Hz), will be measured using objective acoustic voice analysis with Praat software. Measurements will be obtained from sustained vowel /a/ recordings and compared between preoperative and postoperative evaluations.
Change in Jitter Percentage
Time frame: Preoperative, 1 month postoperative, and 3 months postoperative
Jitter, expressed as a percentage (%), will be measured from sustained vowel /a/ recordings using Praat software. Preoperative jitter values will be compared with postoperative measurements at the 1st and 3rd months to assess changes in frequency stability after surgery.
Change in Shimmer Percentage
Time frame: Preoperative, 1 month postoperative, and 3 months postoperative
Shimmer, expressed as a percentage (%), will be measured from sustained vowel /a/ recordings using Praat software. Measurements obtained preoperatively will be compared with postoperative values at the 1st and 3rd months to evaluate changes in amplitude stability following surgery.
Change in Harmonics-to-Noise Ratio (HNR)
Time frame: Preoperative, 1 month postoperative, and 3 months postoperative
Harmonics-to-noise ratio (HNR), measured in decibels (dB), will be obtained from sustained vowel /a/ recordings using Praat software. Preoperative and postoperative (1st and 3rd months) values will be compared to assess changes in voice signal quality after surgery.
3 secondary outcomes
Change in Nasalance Scores After Surgery
Time frame: Preoperative, 1 month postoperative, and 3 months postoperative
Change in Pediatric Voice Handicap Index Scores
Time frame: Preoperative, 1 month postoperative, and 3 months postoperative
Change in Pediatric Voice-Related Quality of Life Scores
Time frame: Preoperative, 1 month postoperative, and 3 months postoperative
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 10 Feb 2026.
- Background: PubMed 23834133Kara M, Ozturk K, Ozer B. An evaluation of the effects of adenoidectomy on voice and speech function in children. Kulak Burun Bogaz Ihtis Derg. 2013 Jul-Aug;23(4):225-31. doi: 10.5606/kbbihtisas.2013.09476.
- BackgroundAdenotonsillektominin Akustik, Algısal ve Aerodinamik Ses Parametrelerine Etkisi. Beyhan Yılmaz, Engin Sengul, Musa Özbay, Salih Bakır. Dicle Tıp Dergisi /Dicle Medical Journal 2016; 43 (2): 333-338. doi: 10.5798/diclemedj.0921.2016.02.0691
- Background: PubMed 31742023Inja RR, Paul RR, Varghese L, Santosh S, Sebastian T, Mathews SS. Voice Change Following Adenotonsillectomy in Pediatric Population: Myth or Reality?-A Pilot Study. Indian J Otolaryngol Head Neck Surg. 2019 Oct;71(Suppl 1):574-579. doi: 10.1007/s12070-018-1412-6. Epub 2018 Jun 4.
- Individual participant dataSharing planned: No. Individual participant data (IPD) from this study will not be shared outside of the research team due to the sensitive nature of pediatric patient data and privacy considerations.
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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.
DERYA CEBECİ, MD principal investigator
Gaziosmanpaşa Training and Research Hospital, Department of Otolaryngology
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 Adenoid Hypertrophy and Tonsillar Hypertrophy, run by Gaziosmanpasa Research and Education Hospital 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 2 inclusion and 11 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: opening soon, as of the sponsor's last update on 10 Feb 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 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?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact DERYA CEBECİ, MD (+90 536 243 20 20, drderyacebeci@gmail.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Change in Fundamental Frequency (F0) (time frame: Preoperative, 1 month postoperative, and 3 months postoperative). The study lists 4 primary outcomes in all. 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 NCT07399041, which also lists 3 linked publications.
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 10 Feb 2026.