Randomized Clinical Trial for Tonsil Surgery in Adults With Obstructive Sleep Apnea and Enlarged Tonsils (TONOS)
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.
研究概览
详细说明
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.
研究类型
注册 (估计的)
阶段
- 不适用
联系人和位置
学习联系方式
- 姓名：Jaakko M Piitulainen, MD, PhD
- 电话号码：+35823130000
- 邮箱：jaakko.piitulainen@utu.fi
研究联系人备份
- 姓名：Henrik Sjöblom, MD
- 电话号码：+35823130000
- 邮箱：henrik.sjoblom@varha.fi
学习地点
-
-
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Helsinki、芬兰
- Helsinki University Hospital
-
接触：
- Johanna Ruohoalho, MD, PhD
- 电话号码：+35894711
- 邮箱：firstname.lastname@hus.fi
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接触：
- Vanhapiha Nelli, MD
-
Oulu、芬兰
- Oulu University Hospital
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接触：
- Aleksi Laajala, MD
- 电话号码：+35886699500
- 邮箱：firstname.lastname@oulu.fi
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接触：
- Alakärppä Antti, MD, PhD
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Tampere、芬兰
- Tampere University Hospital
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接触：
- Saara Markkanen, MD, PhD
- 电话号码：+3583311611
- 邮箱：firstname.lastname@pirha.fi
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接触：
- Saara Lesonen, MD
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Turku、芬兰
- Turku University Hospital
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接触：
- Henrik M Sjöblom, MD
- 电话号码：+35823130000
- 邮箱：hmsjob@utu.fi
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接触：
- Jenny Knubb, MD
- 电话号码：+35823130000
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-
参与标准
资格标准
适合学习的年龄
- 成人
- 年长者
接受健康志愿者
描述
Inclusion Criteria:
- BMI < 35
- Tonsil size 2 - 4
- Otherwise healthy patient fit for tonsil surgery
- Apnea-hypopnea index > 15
- Obstructive sleep apnea symptoms
Exclusion Criteria:
- Pathological hemostasis or use of anticoagulation
- Craniofacial deformities
- Neurological condition with muscular hypotonia
- Other surgical treatment for OSA
学习计划
研究是如何设计的？
设计细节
- 主要用途：治疗
- 分配：随机化
- 介入模型：并行分配
- 屏蔽：三倍
武器和干预
参与者组/臂 |
干预/治疗 |
|---|---|
|
有源比较器：Tonsillectomy
TE will be performed by dissection in the peritonsillar plane. Parts of the upper and lateral palatal mucosal arches will be incised, and an extracapsular dissection for complete tonsil excision will be performed. The surgical instrumentation (eg. cold steel, monopolar diathermy with a pen electrode, bipolar scissors, coblation technique or a microdebrider) is selected by the surgeon. |
TE will be performed by dissection in the peritonsillar plane.
Parts of the upper and lateral palatal mucosal arches will be incised, and an extracapsular dissection for complete tonsil excision will be performed.
|
|
有源比较器：Tonsillotomy
TT will be performed by removing approximately 60 - 90% of the tonsillar tissue, leaving a rim of tonsillar tissue on the tonsillar fossae. The tonsil capsule will not be breached. The surgical instrumentation (eg. cold steel, monopolar diathermy with a pen electrode, bipolar scissors, coblation technique or a microdebrider) is selected by the surgeon. |
TT will be performed by removing approximately 60 - 90% of the tonsillar tissue, leaving a rim of tonsillar tissue on the tonsillar fossae.
The tonsil capsule will not be breached.
|
研究衡量的是什么？
主要结果指标
结果测量 |
措施说明 |
大体时间 |
|---|---|---|
|
Changes in AHI at baseline and after surgery
大体时间：baseline, 4-6, 24 and 60 months after surgery.
|
The primary outcome is changes in AHI measured with home sleep study
|
baseline, 4-6, 24 and 60 months after surgery.
|
次要结果测量
结果测量 |
措施说明 |
大体时间 |
|---|---|---|
|
Daytime sleepiness
大体时间：Baseline and 6, 12, 24 and 60 months after surgery
|
Measured with Epworth Sleepiness Scale (ESS) questionnaire (patient-reported).
Points 0-18, higher is worse.
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Baseline and 6, 12, 24 and 60 months after surgery
|
|
Changes in insomnia symptoms
大体时间：Baseline and 6, 12, 24 and 60 months after surgery
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Measured with Insomnia Severity Index (ISI) questionnaire, points range 0-28, higher is worse.
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Baseline and 6, 12, 24 and 60 months after surgery
|
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Surgical success rate
大体时间：Baseline and 6, 12, 24 and 60 months after surgery
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Defined according to Sher's criteria: a reduction in AHI of >50% and a total AHI of <20 after surgery
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Baseline and 6, 12, 24 and 60 months after surgery
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Surgical cure rate
大体时间：Baseline and 6, 12, 24 and 60 months after surgery
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Defined as a total AHI of <5 after surgery
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Baseline and 6, 12, 24 and 60 months after surgery
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Changes in nocturnal desaturation
大体时间：Before surgery and 4-6, 24 and 60 months after surgery
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Changes in nocturnal desaturation measured with oxygen saturation (SaO2) mean, min, and SpO2 <90% (T90) and ODI3, measured with home sleep study
|
Before surgery and 4-6, 24 and 60 months after surgery
|
合作者和调查者
调查人员
- 研究主任：Jaakko M Piitulainen, MD, PhD、Turku University Hospital
- 首席研究员：Henrik Sjöblom, MD、Turku University Hospital
- 首席研究员：Jenny Knubb, MD、Turku University Hospital
研究记录日期
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研究完成 (估计的)
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首次提交
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首次发布 (实际的)
研究记录更新
最后更新发布 (实际的)
上次提交的符合 QC 标准的更新
最后验证
更多信息
与本研究相关的术语
其他研究编号
- VARHA/28047/13.02.02/2025
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