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临床试验/NCT04053738
NCT04053738已完成不适用

An Intelligent Bed To Monitor And Reduce Snoring

Swiss Federal Institute of Technology2 个研究点 分布在 1 个国家目标入组 22 人开始时间: 2017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
22
试验地点
2
主要终点
Effect on snoring

研究概览

简要总结

Habitual snoring is a widespread complication. Most snorers snore predominately when sleeping in supine position. Therefore, therapeutic interventions force snorers to avoid supine position. Devices that restrict the sleeping position or raise alarms when the user obtains the supine position cause discomfort or disrupt sleep resulting in low compliance. Therefore, anti-snoring mechanisms, which lift the trunk of the user without disturbing sleep, have been proposed.

We set out to investigate whether individual interventions provided by beds with lifting mechanisms are able to stop snoring within three minutes (success rate) and whether the bed reduces the snoring index (number of total snores divided by total time in bed). In addition, we investigat whether the trunk elevation provided by the bed is interfering with the subjective sleep quality assessed using the Groningen Sleep Quality Score.

Subjects are observed for four nights (adaptation, baseline, and two intervention nights). During intervention nights, the bed lifts the trunk of the user in closed-loop manner. Subjects are divided in three groups (non-snorers, snorer group one, and snorer group two). Non-snorers are lifted by the bed at random time points during the night. In snorer group one, a stepwise increase of the bed inclination is compared with going directly to a randomly selected angle. In snorer group two, the influence of a small inclination angle (10°) and a big inclination angle (20°) is compared..

研究设计

研究类型
Interventional
分配方式
Randomized
干预模型
Crossover
主要目的
Treatment
盲法
Single (Participant)

盲法说明

Participants were not informed prior to going to bed whether the night would be an intervention night or not

入排标准

年龄范围
18 Years 至 100 Years(Adult, Older Adult)
性别
All
接受健康志愿者

入选标准

  • 未提供

排除标准

  • Pregnancy
  • Previously diagnosed sleep-related breathing disorders
  • Chronic lower back pain
  • Heart insufficiency that might impede sleeping in supine position
  • Inability to follow the procedures of the study, e.g. due to language problems

研究组 & 干预措施

Baseline

No Intervention

Participants slept in the anti-snoring bed in the laboratory, but the bed did not provide any intervention

Anti-snoring Intervention

Experimental

Participants slept in the anti-snoring bed in the laboratory, and the bed moved the trunk of the participant

干预措施: Anti-snoring bed (Device)

结局指标

主要结局

Effect on snoring

时间窗: whole night - 4 nights

Number of episodes of snoring that are terminated by intervention. Snoring activity was monitored using a portable home-monitoring device (Apnea Link plus, purchased from ResMed, Switzerland). This device records oxygen saturation, nasal airflow, and breathing effort. The device comes with a software package that automatically scores the data according to the sleep scoring rules of the American Academy of Sleep Medicine (AASM). Since audio based detection has been reported to be the most reliable way of snoring detection , we also used a sound level meter (XL2 Audio and acoustic Analyzer, purchased from NTi Audio, Lichtenstein) for manual visual-audio scoring of snoring sound. The sound level meter was placed approximately in the position where you would usually expect the head of the bed partner. Manual visual-audio scoring of the data collected with the noise level meter was performed using the XL2 data explorer.

次要结局

  • Self-Reported Sleep Quality(upon awakening - 4 nights)

研究者

申办方类型
Other
责任方
Sponsor

研究点 (2)

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