跳至主要内容
临床试验/NCT01223859
NCT01223859已完成不适用

The Impact of Pretreatment Assessment of Oropharynx on Interstitial Soft Palate Radiofrequency Surgery Outcome - a Multi-center Study in Patients With Habitual Snoring

University of Helsinki0 个研究点目标入组 74 人开始时间: 2008年1月1日最近更新:
适应症
干预措施

试验速览

阶段
不适用
状态
已完成
入组人数
74
主要终点
VAS

研究概览

简要总结

Interstitial radiofrequency (RF) surgery of the soft palate (SP) is an established option in the treatment of habitual snoring. The decision making process in the management of habitual snoring would benefit from diagnostic guidelines for oropharyngeal findings. The aim was to investigate the correlation of systematic clinical pretreatment oropharyngeal examination scores with the efficacy of interstitial RF surgery of SP in a multi-center study

详细描述

TABLE 1. The inclusion and exclusion criterion used for the multicenter study.

Criteria Inclusion Exclusion _____________

Age (years) 18-65 < 18, > 65

Habitual snoring yes no Excessive daytime sleepiness no yes

BMI (kg/m2) < 28 > 28

研究设计

研究类型
Interventional
分配方式
Non Randomized
干预模型
Single Group
主要目的
Treatment
盲法
None

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
是

入选标准

  • •The inclusion and exclusion criterion used for the multicenter study.
  • •Criteria Inclusion Exclusion _____________
  • •Age (years) 18-65 < 18, > 65
  • •Habitual snoring yes no Excessive daytime sleepiness no yes
  • •BMI (kg/m2) < 28 > 28
  • •AHI (events/hour) < 15 > 15
  • •Overjet (mm) < 5 > 5 Clinical suspicion of obstruction no yes at base of tongue
  • •Size of palatine tonsils (grade) 0-II III-IV
  • •Nose breathing problems no yes
  • •Pharyngeal tonsil hypertrophy no yes
  • •A bed partner to assess snoring yes no
  • •_____________
  • •Abbreviations: BMI = body mass index, AHI = apnea-hypopnea index.

排除标准

  • 未提供

研究组 & 干预措施

intervention

Experimental

Interstitial soft palate RF surgery

干预措施: Interstitial soft palate surgery (Procedure)

结局指标

主要结局

VAS

时间窗: 3 months postoperatively

Visual analogue scale snoring patient and bed partner

次要结局

未报告次要终点

研究者

申办方类型
Other

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