The Heads-Up Trial: Sleeping in a Head-Up Tilt Position to Alleviate Orthostatic Hypotension, Supine Hypertension and Nocturia in Parkinson's Disease
试验速览
- 阶段
- 不适用
- 状态
- 进行中（未招募）
- 入组人数
- 50
- 试验地点
- 4
- 主要终点
- Average overnight supine blood pressure
研究概览
简要总结
Autonomic dysfunction is common and often underrecognized in Parkinson's disease (PD). Orthostatic hypotension (OH) affects up to a third of PD patients and often coincides with supine hypertension. This co-occurrence complicates pharmacological treatment as treatment of one can negatively affect the other. Head-up tilt sleeping (HUTS) could improve both. This phase II randomized controlled trial (RCT) aims to investigate the efficacy and tolerability of this understudied intervention, leading to optimal implementation strategies.
详细描述
Autonomic dysfunction is common and often underrecognized in Parkinson's disease (PD). Orthostatic hypotension (OH) affects up to a third of PD patients and about half of them also exhibit supine hypertension. In current clinical practice both are undertreated. The common co-occurrence of OH and supine hypertension complicates pharmacological treatment as improvement of one can be accomplished only at the expense of the other. Head-up tilt sleeping (HUTS) is the only intervention known that could improve both. The concept of HUTS is based on several small-scale observational studies and expert opinion. Although HUTS has been proposed as an effective and even first choice non-pharmacological treatment for OH for over three decades, it is often not advised to patients because of lack of evidence on its effectiveness and on how to implement it. The Heads-Up trial is a multicenter home-based double-blind phase II RCT. The study aims to investigate the efficacy and tolerability of HUTS, leading to optimal implementation strategies of HUTS to treat orthostatic hypotension and supine hypertension.
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
- Double (Participant, Investigator)
盲法说明
Both the investigator and the participants are blinded to treatment allocation.
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
- •Orthostatic hypotension defined as a systolic BP decrease of ≥20 mmHg, or a diastolic decrease of ≥10 mmHg, within 3 min after changing from a supine to standing position OR mean standing BP of ≤75 mmHg (marker for symptomatic orthostatic hypotension). In patients with supine hypertension, a decrease in systolic BP of ≥ 30 mmHg is required;
- •Orthostatic intolerance: direct complaints (dizziness, blurry vision, etc.) and/or indirect signs (falls or freezing episodes that relate to postural challenge);
- •Supine hypertension defined as a systolic BP of ≥140 mmHg, and/or diastolic of ≥90 mmHg, after 5 min of supine rest;
- •Idiopathic PD or parkinsonism (multiple system atrophy, progressive supranuclear palsy, corticobasal degeneration, vascular parkinsonism and Lewy body dementia);
- •Ability to walk (with or without a walking aid), as subjectively determined by the researcher;
- •Stable medication regimens for orthostatic hypotension and supine hypertension during the trial;
排除标准
- •Inability to follow instructions and complete questionnaires, as assessed by the researcher;
结局指标
主要结局
Average overnight supine blood pressure
时间窗: Measured four times: in week 1, 3, 5 and 7
Average overnight supine blood pressure (mmHg) from the 24h ambulatory blood pressure measurement (ABPM)
次要结局
- 24h ABPM parameters(In week 1, 3, 5 and 7)
- Orthostatic tolerance(Week 1, 3, 5 and 7)
- Daily supine blood pressure(Daily in week 1 up to and including week 7)
- Orthostatic blood pressure(Measured six times: in-clinic (T0; pre-intervention), in week 1, 3, 5 and 7, and in-clinic on the day after week 7 ends (T1; post-intervention))
- Nocturia(Week 1, 3, 5 and 7)
- Barriers and facilitators of the intervention(Immediately post-intervention (day after week 7, T1))
- Subjective comfort of HUTS (head up tilted sleeping)(Week 1, 3, 5 and 7)
- Falls(Week 1, 3, 5 and 7)
- Overnight change in body weight(Daily in week 1 up to and including week 7)
- Nighttime urine production(Week 1, 3, 5 and 7)