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