Home Polygraphic Recording With Telemedicine Monitoring for Diagnosis and Treatment of Sleep Apnea in Stroke (HOPES)
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 发起方
- 入组人数
- 34
- 试验地点
- 2
- 主要终点
- CPAP adherence in minutes used per night
研究概览
简要总结
Study Objectives:
Meta-analyses report a high prevalence of moderate to severe sleep apnea of more than 50% in stroke patients, with adherence rates for CPAP therapy of only 30%.
The primary objective of this study is to determine whether CPAP adherence in stroke patients with obstructive sleep apnea can be improved by a CPAP training strategy during rehabilitation combined with a telemedicine monitoring system after discharge.
The secondary objective is to compare recording quality as well as subjective and objective sleep data of non-attended level III polygraphy, polysomnography and telemetric CPAP data in the management of sleep apnea in stroke.
Further the investigators aim to study changes in nocturnal systolic blood pressure due to CPAP therapy with the pulse transit time method.
Finally, the investigators intend to study the relationship between CPAP compliance, sleep and medical and neurorehabilition outcome parameters.
Design:
Single-blind, mono-center, randomized controlled trial on standard CPAP treatment as compared with CPAP treatment with a telemedicine monitoring system in stroke patients with moderate to severe OSA.
Setting: Neurorehabilitation center in Vienna, Austria
Patients: Adult subacute (1 to 12 months post stroke) stroke patients 18-70 yrs of age) with moderate to severe OSA (apnea hypopnea index (AHI) ≥ 15/hr) determined by non-attended polysomnography (AHI) ≥ 15/hr of sleep) or level III polygraphy (AHI) ≥ 30/hr of out-of-center sleep testing (OCST), who undergo successful CPAP training and titration (goal AHI< 10) at the neurorehabilitation unit.
Interventions: Patients will be randomized to either standard care with an autotitrating CPAP device or an autotitrating CPAP device that transmits physiologic information (i.e., adherence, air leak, residual AHI) daily to a website that will be reviewed by their homecare provider. If any problems are identified, the patient will be contacted by his homecare provider by telephone. Neurologists performing sleep and neurological scoring will be blinded to the randomization.
Measurements: Recording of the different measuring systems, subjective and objective sleep quality, CPAP adherence after 3 months and 1 year in hours used per night, systolic BP determined by means of a non-linear algorithm and an individual one-point calibration of the pulse transit time obtained with a cuff-based BP measuring system (SOMNOmedics GmbH, Germany) and neurorehabilitation outcome parameters as Barthel Index, Timed Up and Go Test.
详细描述
The investigators intend to perform a single-blind, mono-center, randomized controlled trial on standard CPAP treatment as compared with CPAP treatment with a telemedicine monitoring system in stroke patients with moderate to severe OSA.
Patients accepting CPAP therapy after successful titration will be randomized to either a standard care or a telemedicine group (1:1 ratio) and will subsequently be informed about the study arm by their homecare provider. The study was approved by the Clinical Research Ethics Board of the public health services of Vienna.
Written informed consent for all examinations will be obtained upon patients' admission. If patients agree to undergo CPAP monitoring, further informed consent will be obtained. The study will be performed in accordance with the relevant guidelines of the Declaration of Helsinki, 1964, as amended in Tokyo, 1975, Venice, 1983, Hong Kong, 1989, and Somerset West, 1996.
Screening Sleep Studies
Over the four to eight weeks of neurorehabilitation, each stroke patient ( 19-70 yrs of age) will be offered a nocturnal respirographic screening evaluation of SA (see study flow chart). Within the study period the investigators expect to screen 170 patients per year.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Treatment
- 盲法
- Single (Investigator)
入排标准
- 年龄范围
- 18 Years 至 70 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Adults (18-70 yrs of age) with a subacute stroke (1-12 months)
- •Diagnosis of sleep apnea and acceptance of CPAP therapy:
排除标准
- •Patients with sopor/coma
- •Any form of dementia (Mini-Mental State Examination <20)
- •Previously diagnosed sleep apnea and established CPAP therapy
- •Purely central sleep apnea
- •Chronic obstructive pulmonary disease more than Gold III
- •Severe kidney diseases
- •Coexisting causes of daytime sleepiness (e.g. narcolepsy, night or rotating shift-work; self-reported average sleep duration <4 h)
- •A major psychiatric or any other acute medical condition
- •Patients unable or unwilling to comply with the protocol
结局指标
主要结局
CPAP adherence in minutes used per night
时间窗: after 3 months
次要结局
- systolic BP(Change from baseline systolic blood pressure to CPAP systolic blood pressure at three months)