Multicenter, National, Randomized, Patient-Blinded, Parallel Group, Non-Inferiority Trial To Compare Tonsillotomy Versus Extracapsular Tonsillectomy in Adults With Obstructive Sleep Apnea and Tonsil Hypertrophy: The TONOS Trial.
试验速览
- 阶段
- 不适用
- 状态
- 尚未招募
- 入组人数
- 132
- 试验地点
- 4
研究概览
简要总结
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.
详细描述
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.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Treatment
- 盲法
- Triple (Participant, Investigator, Outcomes Assessor)
盲法说明
Due to the nature of surgical intervention, surgeon and care providers in the operation theatre are not blinded to treatment allocation. Trial participants, outcome assessors, and data analysts are blinded.
入排标准
- 年龄范围
- 18 Years 至 65 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •BMI < 35
- •Tonsil size 2 - 4
- •Otherwise healthy patient fit for tonsil surgery
- •Apnea-hypopnea index > 15
- •Obstructive sleep apnea symptoms
排除标准
- •Pathological hemostasis or use of anticoagulation
- •Craniofacial deformities
- •Neurological condition with muscular hypotonia
- •Other surgical treatment for OSA
研究者
Jaakko Piitulainen
MD, PhD
Turku University Hospital