CompletedNot Applicable

Tonsillectomy and Expansion Sphincter Pharyngoplasty Operations

Turkey (Türkiye)53 participantsStarted 2022-01-01

Plain-language summary

Background: To compare the efficacy of tonsillectomy and expansion sphincter pharyngoplasty (ESP) in the surgical treatment of obstructive sleep apnea (OSA). Methods: Patients with Friedman grade III-IV tonsil hypertrophy and OSA diagnosed with polysomnography were separated into two groups according to the surgery performed, as the classic tonsillectomy group (Group 1) and the ESP group (Group 2). The primary endpoint of the study was to determine the Apnea-Hypopnea Index (AHI) value. The preoperative and postoperative AHI scores and the decreases in these scores were noted. The change in AHI was calculated as a percentage (preoperative AHI - postoperative AHI/ preoperative AHI x 100) and the two groups were compared. An AHI value of \<10 events/hour was accepted as cure.

Who can participate

Age range

27 Years – 64 Years

Sex

ALL

See this in plain English?

AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.

Inclusion Criteria: * patients aged \>27 years * Apnea-Hypopnea Index (AHI) value of ≥10. Exclusion Criteria: * absent preoperative and/or postoperative PSG * craniofacial anomaly such as evident retrognathia * severe cardiac, respiratory, or neurological disease * an evident obstruction at the tongue base level in the endoscopic examination

Questions worth asking your doctor

Bring these to your next appointment. They're a starting point for a shared conversation — not a sign you qualify or a recommendation to enrol.

1Based on my diagnosis and history, is this trial worth exploring for me — or is there a standard treatment we should try first?
2What does this trial's phase tell us about how much is already known about its safety and benefit?
3What would taking part actually involve for me — visits, tests, time, and travel?
4What are the known and possible risks or side effects I should weigh, and how would they be monitored?
5If this trial isn't the right fit, what other options or trials would you suggest I look into?

Generated to help you prepare — always confirm anything about your own eligibility and care with the study team and your doctor.

Questions for the trial coordinator

The trial coordinator is the person who runs the study day to day. These cover the practical side — logistics, costs, and what taking part would actually mean for your life. The study team confirms whether you meet the criteria; these are questions to ask, not a sign you qualify.

1What does taking part actually involve week to week — how many visits, where, and how long does each one take?
2What costs are covered by the study, and what might I have to pay for myself, including travel, parking, or time off work?
3What happens during screening, and what happens if the study team confirms I don't meet the criteria after those tests?
4Who pays for the scans, blood work, and other tests the trial requires — the study, my insurance, or me?
5How will being in the trial affect my regular care, and will my own doctor stay informed and involved?
6Can I leave the trial at any point if I change my mind, and what would happen to my care if I do?

A starting point for the conversation — always confirm anything about your own eligibility, costs, and care with the study team and your doctor.

What they're measuring

Apnea-Hypopnea Index (AHI)

Timeframe: 1 hour

Trial details

NCT IDNCT06119841

SponsorSaglik Bilimleri Universitesi

Sponsor typeOTHER

Study typeINTERVENTIONAL

Primary completion2023-02-28

View on ClinicalTrials.gov More Obstructive Sleep Apnea trials