跳至主要内容
临床试验/NCT04387812
NCT04387812招募中不适用

Evaluation of the Frequency and Severity of Sleep Abnormalities in Patients With Parkinson's Disease (PD)

Tel-Aviv Sourasky Medical Center2 个研究点 分布在 1 个国家目标入组 240 人开始时间: 2020年6月1日最近更新:
适应症

试验速览

阶段
不适用
状态
招募中
入组人数
240
试验地点
2
主要终点
Changes in sleep architecture

研究概览

简要总结

Sleep disturbances are one of the most common non-motor symptoms in PD, with an estimated prevalence as high as 40-90%. Sleep disturbances (particularly sleep duration, sleep fragmentation, Rapid Eye Movement (REM) sleep behavior disorder and sleep-disordered breathing) have been associated with an increased risk of neurodegeneration and are an independent risk for cognitive decline and dementia in PD.

Although much is currently unknown about sleep changes in PD, sleep-related symptoms are increasingly recognized as a major contributor to disease burden and reduced quality of life among people with PD. The "gold standard" evaluation of nocturnal sleep is polysomnographic monitoring (PSG).

This study proposes to use novel wireless skin electrodes and wearable sensors to provide a "home PSG test" incorporating several physiologic recordings, over multiple nights in the person's home, enabling the objective evaluation of night-to-night fluctuations.

详细描述

Background Sleep disturbances are one of the most common non-motor symptoms in PD, with an estimated prevalence as high as 40-90%. Sleep disturbances (particularly sleep duration, sleep fragmentation, Rapid Eye Movement (REM) sleep behaviour disorder and sleep-disordered breathing) have been associated with an increased risk of neurodegeneration and are an independent risk for cognitive decline and dementia in PD. The etiology of impaired sleep and alertness in PD is multifactorial and may be due to the interactions between internal and external factors such as primary sleep disorders, primary neurodegeneration, medication side effects, environmental conditions and genetic factors (either associated with sleep or associated with disease phenotype). Each can contribute to sleep disturbances alone or as modifiers, resulting in variability of presentation and symptoms, affecting both the diagnosis, and the treatment of these disorders. Although much is currently unknown about sleep changes in PD, sleep-related symptoms are increasingly recognized as a major contributor to disease burden and reduced quality of life among people with PD.

The "gold standard" evaluation of nocturnal sleep is polysomnographic monitoring (PSG). PSG consists of measuring neural function, eye movements, muscle activity, respiratory status and electrocardiography activity while the person sleeps over-night in a laboratory setting. This assessment allows for quantification of the different sleep stages during non-REM and REM, evaluation of their distribution over the course of the night, and the identification of impairments in each of these stages. However, PSG is time, cost and labor-intensive, may not reflect the typical behavior of the person due to the unfamiliar environment and irregular sleeping conditions, and more importantly, only provides information on one night of sleep.

In recent years, there is heightened interest in home-based sleep monitoring via wearable sensors to address these shortcomings. Body-fixed electrophysiological sensors can objectively quantify sleep quality, generating a detailed map of the person's sleeping pattern and nocturnal movements. They are relatively inexpensive enabling wide-spread use.

This study proposes to use novel wireless skin electrodes and wearable sensors to provide a "home PSG test" incorporating several physiologic recordings, over multiple nights in the person's home, enabling the objective evaluation of night-to-night fluctuations. By applying these novel tools to the study of people with PD as well as controls and subjects at risk for developing PD, the results of this study will open the door for using a new method for assessment of prodromal signs and disease progression.

Study objective

研究设计

研究类型
Interventional
分配方式
Na
干预模型
Single Group
主要目的
Diagnostic
盲法
None

入排标准

年龄范围
50 Years 至 80 Years(Adult, Older Adult)
性别
All
接受健康志愿者

入选标准

  • Diagnosis of PD (according to UK brain bank or Gelb criteria)
  • Hohen and Yahr stages I-IV
  • Age between 50-80
  • First-degree healthy relatives, carriers of mutations in the LRRK2 and GBA genes
  • Healthy volunteers
  • Healthy subjects with confirmed RBD
  • For patients with PD: only if they have a care partner at home who will be able to assist with the application of the technology
  • Willing and able to sign an informed consent

排除标准

  • Any neurological condition other than PD (e.g. Stroke, MSA, parkinsonism)
  • Severe cognitive impairment (MoCA<24)
  • Psychiatric disorders
  • Low back pain or any orthopaedic problem or pain that will prevent the subject from sleeping in the sleep lab or wearing the wearable sensors
  • For men: a beard (because of the tattoo adhesion

结局指标

主要结局

Changes in sleep architecture

时间窗: From placing the system to disassembling, up to 1 week

Frequency of RBD and severity of sleep interruptions

次要结局

  • Geriatric Depression Scale(Immediate after disassembling the system (day 7))
  • The Non-Motor Scale(Immediate after disassembling the system (day 7))
  • MDS-UPDRS(Immediate after disassembling the system (day 7))
  • REM Sleep Behavior Disorder Screening Questionnaire(Immediate after disassembling the system (day 7))

研究者

申办方类型
Other Gov
责任方
Sponsor

研究点 (2)

Loading locations...

相似试验

Evaluation of the Frequency and Severity of Sleep... | 临床试验