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临床试验/NCT04199299
NCT04199299招募中不适用

The Use of Sensors to Improve Communication for Persons With Intellectual Disability Who Cannot Communicate Unequivocally

University of Oslo1 个研究点 分布在 1 个国家目标入组 100 人开始时间: 2020年2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
100
试验地点
1
主要终点
Caregivers' practice detailed in structured interview

研究概览

简要总结

Some persons with intellectual disability or comprehensive cerebral palsy cannot communicate unequivocally how they are, how they react to situations and people, whether they are in pain or experience discomfort, anger or fear. Their modes of communication (sounds, grimacing etc) may be unintelligible or ambiguous to their caregivers.

With the use of heart and/or respiration monitors the investigators aim to give these persons a means to communicate their immediate reactions or responses. The respiration monitor is meant to register sleep at night, so that the participants can communicate whether they have slept well or not the previous night.

详细描述

Heart rate (HR) is considered to reflect a persons autonomic response to situations, whether external (what happens around us) or internal (pain or pleasure, joy or fear). Some persons with severe intellectual disability or comprehensive cerebral palsy or childhood autism cannot communicate unequivocally, either because they lack the cognitive prerequisites and language or because they lack control over their muscles used for speech.

The investigators believe that these persons, through their heart rate, as registered with a commercially available chest belt or wrist watch, may communicate something about their well being and their reactions, preferences, aversions and fears.

Many persons with intellectual disability, comprehensive cerebral palsy or childhood autism (the participants in this study) have sleep problems, but these may go unnoticed. Participants often have a fixed schedule for the day, and this is carried out irrespective of the shape they are in, e.g. irrespective of how well they have slept the night before. The challenges may then be too much for a sleep-deprived person, and frustration and even self harm and aggressive behavior may be the result. With the use of a respiration monitor that assesses sleep from the person's breathing pattern, the person in question may be able to communicate to her/his caregivers how the previous night's sleep was.

Information about heart rate and sleep may contribute to better care and health services for persons who are unable to communicate unequivocally because of intellectual disability, autism and/or cerebral palsy.

研究设计

研究类型
Observational
观察模型
Case Only
时间视角
Prospective

入排标准

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

入选标准

  • intellectual disability with or without autism and/or cerebral palsy that render the participant unable to communicate his/her needs and reactions unequivocally.

排除标准

  • allergic skin reaction to chest strap

结局指标

主要结局

Caregivers' practice detailed in structured interview

时间窗: 10 years

Does the practice of the care for persons who cannot communicate unequivocally change after introduction of pulse- and respiration sensors? These questions are addressed in a structured interview with caregivers prior to and 2 months after the introduction of pulse- and respiration sensors.

次要结局

  • Caregivers' understanding of the user detailed in structured interview(10 years)

研究者

申办方类型
Other
责任方
Principal Investigator
主要研究者

Bjørnar Hassel

Professor, Senior consultant

University of Oslo

研究点 (1)

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