Randomized Clinical Trial for Tonsil Surgery in Adults With Obstructive Sleep Apnea and Enlarged Tonsils

Overview

The aim is to investigate whether the tissue-preserving tonsil surgery technique is as effective as complete tonsil removal in the treatment of obstructive sleep apnea. The primary outcome measure is the change in the apnea-hypopnea index (AHI) before surgery and at 4-6, 24, and 60 months after surgery.

Adult reviews suggest tonsillotomy (TT) reduces morbidity compared to tonsillectomy (TE). In pediatric populations, the effectiveness of partial tonsil surgery for sleep apnea (OSA) is well-documented. It remains unclear if TT is non-inferior to TE in adults in the treatment of OSA. This study compares TE with TT in adults using change in apnea-hypopnea index as the primary endpoint. The hypothesis is that TT is non-inferior compared to TE in treating patients with moderate or severe OSA and grade 2 to 4 tonsil size. Participants are blinded to the allocated intervention with an allocation ratio 1:1. Participants will be recruited from patients referred to an outpatient hospital clinic. The trial will be carried out in four tertiary hospitals in Finland.

Conditions

Interventions

Eligibility

Locations (4)

Outcomes

Central Contacts