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临床试验/NCT02204696
NCT02204696撤回不适用

The Role of Tonsillectomy in Adults With Marked Tonsillar Hypertrophy and Obstructive Sleep Apnea

University of Southern California1 个研究点 分布在 1 个国家开始时间: 2010年12月最近更新:
适应症

试验速览

阶段
不适用
状态
撤回
试验地点
1
主要终点
apnea-hypopnea index

研究概览

简要总结

The purpose of the study is to determine if tonsillectomy eliminates symptoms of obstructive sleep apnea in patients with obstructive sleep apnea and marked tonsillar hypertrophy with normal soft palate and uvula length.

详细描述

Purpose: To determine if tonsillectomy eliminates symptoms of obstructive sleep apnea in patients with obstructive sleep apnea and marked tonsillar hypertrophy with normal soft palate and uvula length.

Specific Aims: 1. To determine if tonsillectomy eliminates obstructive sleep apnea as determined by polysomnography. 2. To determine if tonsillectomy eliminates excessive daytime sleepiness and other obstructive sleep apnea symptoms.

Rationale: Current surgical procedures for obstructive sleep apnea include tonsillectomy with soft palate surgery (including uvulopalatopharyngoplasty). Tonsillectomy alone may provide sufficient benefit in adults with marked tonsillar hypertrophy and normal soft palate and uvula length, avoiding the need for additional soft palate surgery.

Intervention: Tonsillectomy will be performed as standard of care, in patients who would be undergoing said surgery regardless of study. Study intervention includes multiple home sleep studies to determine effect of tonsillectomy in impacting symptoms of sleep apnea.

Study Population: Inclusion criteria: Subjects must be at least 18 years old, have documented obstructive sleep apnea; be willing to undergo 3 home sleep studies; and have markedly hypertrophic (3+ or 4+) tonsils. Exclusion criteria: Subjects must not have any craniofacial abnormality; normal soft palate length (<4 cm) and uvula length ((<2 cm); must have no history of chronic obstructive pulmonary disease, untreated psychological disorder, restless leg syndrome, alcohol or drug abuse; must have a body mass index <35; must not plan to use continuous positive airway pressure during the study period, and lack significant nasal obstruction. The subjects will serve as their own control.

研究设计

研究类型
Observational
观察模型
Cohort
时间视角
Prospective

入排标准

年龄范围
17 Years 至 —(Child, Adult, Older Adult)
性别
All
接受健康志愿者

入选标准

  • At least 18 years of age
  • Documented obstructive sleep apnea (with central apneas of the total number of apneas plus hypopneas)
  • Able to complete all forms in English and follow-up appointments
  • Willing to undergo 3 home sleep studies; and markedly hypertrophic (3+ or 4+) tonsils
  • Tonsil size of 3+ or 4+ corresponds to tonsils that occupy more than 50% of the space between the tonsillar fossa (side of the throat) and midline

排除标准

  • No craniofacial abnormality
  • No history of COPD, untreated psychological disorder, other sleep disorder, alcohol or drug abuse
  • Body mass index <35 kg/m2
  • Unable to tolerate other treatments for obstructive sleep apnea
  • Soft palate length > 4 cm
  • Uvula length > 2 cm
  • No significant nasal obstruction

结局指标

主要结局

apnea-hypopnea index

时间窗: 8 weeks

This will be determined by home sleep study.

次要结局

  • Epworth Sleepiness Scale score(8 weeks)
  • Functional Outcomes of Sleep Questionnaire score(8 weeks)

研究者

申办方类型
Other
责任方
Principal Investigator
主要研究者

Eric Kezirian

Professor

University of Southern California

研究点 (1)

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