Validierung Der Peripher Arteriellen Tonometrie Zur Diagnostik Schlafbezogener Atmungsstörungen Bei Patienten Mit Systolischer Herzinsuffizienz
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 发起方
- 入组人数
- 30
- 试验地点
- 1
- 主要终点
- Apnea-Hypopnea-Index (AHI)
研究概览
简要总结
A prospective validation study: Level I-full night-polysomnography (PSG) versus a diagnostic device with measurement of the peripheral arterial tone (PAT) of patients with chronic heart failure (CHF) and sleep-disordered breathing (SDB).
详细描述
Patients with chronic heart failure (CHF), reduced left ventricular ejection fraction (LVEF<45%) and predicted sleep-disordered breathing (SDB) receive a diagnostic device (WatchPAT 200 (TM)) and polysomnography (PSG) simultaneously during on night in a hospital sleep lab.
The WatchPAT 200 (TM) is a wrist worn diagnostic device for detecting SDB. Its main part is the measurement of the peripheral arterial tone (PAT) via a plethysmographic based finger-mounted probe. It can measure the level of sympathetic activation of the autonomic nervous system. Pulse rate, oxygen saturation and snoring/body position levels are calculated, too. A software program (zzzPAT (TM)) with a special algorithm analyzes the raw data and creates a sleep report. Therefore the property of the WatchPAT 200 (TM) proclaims that the WatchPAT 200 (TM) can detect sleep events and SDB.
The PSG is scored by sleep lab physicians/technicians blinded to the zzzPAT (TM)-software results using current American Academy of Sleep Medicine (AASM) guidelines.
Both results will be compared and the results of the device will be validated and evaluated against the results of the "Gold Standard" polysomnography.
研究设计
- 研究类型
- Interventional
- 分配方式
- Non Randomized
- 干预模型
- Crossover
- 主要目的
- Diagnostic
- 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
- •reduced left ventricular ejection fraction (LVEF) < 45 %
- •indication for a polysomnography
排除标准
- •allergies against the device or parts of the device
- •psychogenic or neurological disorders which do not allow a sufficient patient compliance
- •osteogenetic disorders which do not allow a painless investigation
- •pregnancy
研究组 & 干预措施
Polysomnography
The PSG is known as the "Gold Standard" for detecting SDB: experienced sleep physicians and technicians score events (apnea/hypopnea) using current AASM Guidelines.
干预措施: WatchPAT 200 (TM) (Device)
Polysomnography
The PSG is known as the "Gold Standard" for detecting SDB: experienced sleep physicians and technicians score events (apnea/hypopnea) using current AASM Guidelines.
干预措施: Polysomnography (Other)
Diagnostic Device (WatchPAT 200 (TM))
The WatchPAT 200 (TM) is a wrist worn diagnostic device for detecting SDB. Its main part is the measurement of the peripheral arterial tone (PAT) via a plethysmographic based finger-mounted probe. It can measure the level of sympathetic activation of the autonomic nervous system. Pulse rate, oxygen saturation and snoring/body position levels are calculated, too. A software program (zzzPAT (TM)) with a special algorithm analyzes the raw data and creates a sleep report. Therefore the property of the WatchPAT 200 (TM) proclaims that the WatchPAT 200 (TM) can detect sleep events and SDB.
干预措施: WatchPAT 200 (TM) (Device)
Diagnostic Device (WatchPAT 200 (TM))
The WatchPAT 200 (TM) is a wrist worn diagnostic device for detecting SDB. Its main part is the measurement of the peripheral arterial tone (PAT) via a plethysmographic based finger-mounted probe. It can measure the level of sympathetic activation of the autonomic nervous system. Pulse rate, oxygen saturation and snoring/body position levels are calculated, too. A software program (zzzPAT (TM)) with a special algorithm analyzes the raw data and creates a sleep report. Therefore the property of the WatchPAT 200 (TM) proclaims that the WatchPAT 200 (TM) can detect sleep events and SDB.
干预措施: Polysomnography (Other)
结局指标
主要结局
Apnea-Hypopnea-Index (AHI)
时间窗: one night of sleep
Index is stated per hour (/h)
次要结局
- Respiratory Parameters: Obstructive Hypopnea(one night of sleep)
- Respiratory Parameters: Central Hypopnea(one night of sleep)
- Respiratory Parameters: Hypopnea total(one night of sleep)
- Respiratory Parameters: Central Apnea(one night of sleep)
- Respiratory Parameters: Mixed Apnea(one night of sleep)
- Sleep: Total sleep time(one night of sleep)
- Sleep: Sleep latency(one night of sleep)
- Sleep: Rapid-Eye-Movement (REM) sleep latency(one night of sleep)
- Sleep: Time in bed(one night of sleep)
- Sleep: latency to S3(one night of sleep)
- Sleep: Wake(one night of sleep)
- Sleep: S1 stadium/total sleep time(one night of sleep)
- Sleep: S2 stadium/total sleep time(one night of sleep)
- Sleep: S3 stadium/total sleep time(one night of sleep)
- Sleep: REM sleep/total sleep time(one night of sleep)
- Sleep: Sleep Efficiency(one night of sleep)
- Respiratory Parameters: longest Hypopnea(one night of sleep)
- Sleep: Number of Wakes(one night of sleep)
- Respiratory Parameters: Oxygen-Desaturation-Index (ODI)(one night of sleep)
- Respiratory Parameters: longest Apnea(one night of sleep)
- Respiratory Parameters: Obstructive Apnea(one night of sleep)
- Respiratory Parameters: Mean Oxygen Saturation (sO2)(one night of sleep)
- Respiratory Parameters: Minimum Oxygen Saturation (sO2)(one night of sleep)
- Respiratory Parameters: Maximum Oxygen Saturation (sO2)(one night of sleep)
- Respiratory Parameters: Mean of Desaturations Nadirs(one night of sleep)
- Respiratory Parameters: Mean of Desaturations(one night of sleep)
- Respiratory Parameters: Time Oxygen Saturation (TsO2) < 90%(one night of sleep)
- Respiratory Parameters: Apnea + Hypopnea total(one night of sleep)
- Respiratory Parameters: Desaturations(one night of sleep)
- Respiratory Parameters: Respiratory-Disturbance-Index (RDI)(one night of sleep)
- Differences of results of patients with central sleep apnea (CSA) or obstructive sleep apnea (OSA)(one night of sleep)
研究者
Thomas Bitter
Dr. med
Heart and Diabetes Center North-Rhine Westfalia