Night-to-Night Variability of Novel Physiological Parameters in Home Sleep Apnea Testing
试验速览
- 阶段
- 不适用
- 状态
- 招募中
- 入组人数
- 192
- 试验地点
- 2
- 主要终点
- Night-to-night variability of apnea-hypopnea index (events per hour of sleep) over 4 nights
研究概览
简要总结
Obstructive sleep apnea (OSA) is usually diagnosed from a single night of home sleep apnea testing using the apnea-hypopnea index (AHI). However, the AHI varies substantially from night to night, undermining diagnostic accuracy, and shows only modest correlation with symptoms. This variability further limits its usefulness for predicting cardiovascular and other complications. Besides the traditional AHI, more robust physiological markers are needed.
Several emerging physiological metrics - hypoxic burden, ventilatory burden, heart rate variability, autonomic arousals, and the pulse wave amplitude drop index - capture the physiological impact of OSA more comprehensively and demonstrate stronger associations with cardiovascular risk. Despite this promise, their night-to-night variability has not been studied.
A systematic evaluation of both established and novel OSA metrics across nights is essential to identify reliable, stable parameters suitable for clinical routine. This improves diagnostic precision beyond what traditional metrics can provide, enhances patient selection, reduces costs and patient harm, and may improve treatment outcomes.
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
- 18 Years 至 —（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Patients with suspected or diagnosed sleep-disordered breathing, irrespective of disease severity, as defined by the indications for home sleep apnea testing in the German guidelines [15]
- •No active treatment during sleep recordings or within preceding two weeks (e.g., mandibular advancement devices, positive airway pressure therapy)
- •Written informed consent obtained
排除标准
- •Age <18 years
- •Known or suspected neurological sleep disorder (e.g., narcolepsy, parasomnia)
- •Known or suspected psychiatric sleep disorder
- •Known or suspected central and complex sleep apnea
- •Participants who are unable to perform sleep measurements reliably
- •Insufficient knowledge of the project language (German)
- •Inability to give consent
- •Shift workers (with shift work <2 weeks before testing)
研究组 & 干预措施
All participants
Participants will undergo repeated sleep testing using respiratory polygraphy over 4 nights and oximetry over 10 nights, starting in parallel. Before and after the recordings they will fill out symptom questionnaires and patient-reported outcome measures.
结局指标
主要结局
Night-to-night variability of apnea-hypopnea index (events per hour of sleep) over 4 nights
时间窗: 4 nights of respiratory polygraphy
The variability of the apnea-hypopnea index (events per hour of sleep) over 4 nights will be quantified using linear mixed-effects models, accounting for confounding variables.
Night-to-night variability of oxygen desaturation index (events per hour of sleep) over 10 nights
时间窗: 4 nights of respiratory polygraphy and 10 nights of oxymetry
The variability will be quantified using linear mixed-effects models, accounting for confounding variables.
Night-to-night variability of hypoxic burden (minute x percent per hour of sleep) over 10 nights
时间窗: 4 nights of respiratory polygraphy and 10 nights of oxymetry
The variability will be quantified using linear mixed-effects models, accounting for confounding variables.
Night-to-night variability of ventilatory burden over 4 nights
时间窗: 4 nights of respiratory polygraphy
The variability will be quantified using linear mixed-effects models, accounting for confounding variables. Ventilatory burden will be calculated according to Parekh et al.
Night-to-night variability of heart rate variability over 10 nights
时间窗: 4 nights of respiratory polygraphy and 10 nights of oxymetry
The variability will be quantified using linear mixed-effects models, accounting for confounding variables.
Night-to-night variability of pulse wave amplitude drops (events per hour) over 10 nights
时间窗: 4 nights of respiratory polygraphy and 10 nights of oxymetry
The variability will be quantified using linear mixed-effects models, accounting for confounding variables.
次要结局
- Identification of factors contributing to and explaining variability(4 nights of respiratory polygraphy and 10 nights of oxymetry)
- Association between physiological parameters from sleep testing and PROMs(4 nights of respiratory polygraphy and 10 nights of oxymetry)
- Correlation between physiological parameters from sleep testing and patient-reported outcome measures (PROMs)(4 nights of respiratory polygraphy and 10 nights of oxymetry)