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临床试验/NCT05643352
NCT05643352进行中(未招募)不适用

Patient-reported Outcomes of Barbed Reposition Pharyngoplasty in Unilevel Palatal Snoring: a Prospective Study

AZ Delta2 个研究点 分布在 1 个国家目标入组 16 人开始时间: 2022年10月1日最近更新:
适应症

试验速览

阶段
不适用
状态
进行中(未招募)
发起方
AZ Delta
入组人数
16
试验地点
2
主要终点
Change in Snoring score

研究概览

简要总结

The aim of the study is to determine whether there is a statistically significant difference in snoring intensity before and after performing a Barbed Reposition Pharyngoplasty as a single-level snoring procedure. The investigators aim to determine whether this is a valid alternative to the more classical techniques of pharyngoplasty. Furthermore, the investigators also wish to map the various postoperative complications and compare them with those of the more conventional techniques. The investigators compare the snoring intensity before surgery with the snoring intensity at 2 weeks (first postoperative control), at 6 weeks (second postoperative control) and at 6 months (Third postoperative control).

For the evaluation of snoring, the investigators use 4 scales/questionnaires. These questionnaires are currently also used as standard at the outpatient clinic for snoring problems. These 4 scales/questionnaires are completed at every check-up.

During the first postoperative check-up, the postoperative side effects are checked (bleeding, infection, readmission, needed consultation with another doctor, date of resumption of work). The investigators also map the pain with a visual analog scale and measure this the day after the operation and let the patient fill it in 3 days, 1 week and 2 weeks after the operation.

研究设计

研究类型
Interventional
分配方式
Na
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 —(Adult, Older Adult)
性别
All
接受健康志愿者

入选标准

  • single-level retro-palatal collapse observed during drug-induced sleep endoscopy (DISE)

排除标准

  • OSAS defined as having an obstructive AHI (OAHI) ≥ 30
  • Obese patients with a body mass index (BMI) ≥ 30 kg/m².
  • Patients with multilevel airway collapse observed during DISE
  • Patients younger than 18 years old.

结局指标

主要结局

Change in Snoring score

时间窗: At 2 weeks, at 6 weeks and at 6 months

Seld-reported subjective score that describes the overall loudness of snoring with score of 0 meaning no snoring and 10 meaning extreme snoring

Change in Snoring intensity

时间窗: At 2 weeks, at 6 weeks and at 6 months

Seld-reported subjective score from 0 to 10 that describes the impact of snoring with 0 meaning no snoring and 10 meaning sleeping separately from partner

Change in Snoring severity

时间窗: At 2 weeks, at 6 weeks and at 6 months

Seld-reported subjective score that describes the severity of snoring (frequency, duration,...). Score from 0 to 9 with 0 meaning never snoring and 9 meaning snoring every night during the entire night with sounds audible from another floor

次要结局

  • Change in Epworth Sleepiness Scale(At 2 weeks, at 6 weeks and at 6 months)

研究者

发起方
AZ Delta
申办方类型
Other
责任方
Sponsor

研究点 (2)

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