NCT07399041

Brief 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. 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.

Trial Health

63
Monitor

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
36

participants targeted

Target at P25-P50 for all trials

Timeline
3mo left

Started Feb 2026

Shorter than P25 for all trials

Geographic Reach
1 country

1 active site

Status
not yet recruiting

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

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Study Timeline

Key milestones and dates

Study Progress53%
Feb 2026Aug 2026

First Submitted

Initial submission to the registry

January 23, 2026

Completed
9 days until next milestone

Study Start

First participant enrolled

February 1, 2026

Completed
9 days until next milestone

First Posted

Study publicly available on registry

February 10, 2026

Completed
5 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

July 1, 2026

Expected
1 month until next milestone

Study Completion

Last participant's last visit for all outcomes

August 1, 2026

Last Updated

February 10, 2026

Status Verified

February 1, 2026

Enrollment Period

5 months

First QC Date

January 23, 2026

Last Update Submit

February 2, 2026

Conditions

Adenoid HypertrophyTonsillar HypertrophyVoice Disorders in Children

Keywords

AdenoidectomyAdenotonsillectomyPediatric VoiceNasalancepraat

Outcome Measures

Primary Outcomes (4)

  • 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.

    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.

    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.

    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.

    Preoperative, 1 month postoperative, and 3 months postoperative

Secondary Outcomes (3)

  • Change in Nasalance Scores After Surgery

    Preoperative, 1 month postoperative, and 3 months postoperative

  • Change in Pediatric Voice Handicap Index Scores

    Preoperative, 1 month postoperative, and 3 months postoperative

  • Change in Pediatric Voice-Related Quality of Life Scores

    Preoperative, 1 month postoperative, and 3 months postoperative

Study Arms (1)

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.

Eligibility Criteria

Age4 Years - 13 Years
Sexall
Healthy VolunteersNo
Age GroupsChild (0-17)
Sampling MethodNon-Probability Sample
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.

You may qualify if:

  • Aged 4-13 years
  • Scheduled for primary adenoidectomy or adenotonsillectomy

You may not qualify if:

  • 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
  • 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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Gaziosmanpaşa Training and Research Hospital

Istanbul, 34245, Turkey (Türkiye)

Location

Related Publications (3)

  • An evaluation of the effects of adenoidectomy on voice and speech function in children. Medine Kara, Kayhan Öztürk, Bedri Özer. Kulak Burun Bogaz Ihtis Derg 2013;23(4):225-231. doi: 10.5606/kbbihtisas.2013.09476.

    BACKGROUND

  • Adenotonsillektominin 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

  • 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.

    PMID: 31742023BACKGROUND

Study Officials

  • DERYA CEBECİ, MD

    Gaziosmanpaşa Training and Research Hospital, Department of Otolaryngology

    PRINCIPAL INVESTIGATOR

Central Study Contacts

DERYA CEBECİ, MD

CONTACT

+90 536 243 20 20drderyacebeci@gmail.com

Study Design

Study Type
observational
Observational Model
COHORT
Time Perspective
PROSPECTIVE
Sponsor Type
OTHER GOV
Responsible Party
SPONSOR

Study Record Dates

First Submitted

January 23, 2026

First Posted

February 10, 2026

Study Start

February 1, 2026

Primary Completion (Estimated)

July 1, 2026

Study Completion (Estimated)

August 1, 2026

Last Updated

February 10, 2026

Record last verified: 2026-02

Data Sharing

IPD Sharing
Will not share

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.

Locations

TU(1)