Sensors for Communication for Persons Who Cannot Communicate Unequivocally

Официальное название

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

Обзор

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.

Подробное описание

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.

Вмешательства

• Устройство Heart rate and respiration rate sensors
  The use of sensors to monitor physiological variables (e.g. heart rate, sleep). The design is a before-and-after comparison with respect to whether the use of sensors has changed the caregivers' practice and their (perceived) understanding of the participant. The frequency of participants' self harm or aggressive behavior after as compared to before the introduction of pulse- and respiration monitors will also be charted.

Первичные конечные точки

• Caregivers' practice detailed in structured interview [Срок оценки: 10 years]

Вторичные конечные точки (1)

• Caregivers' understanding of the user detailed in structured interview [Срок оценки: 10 years]

Критерии участия

Критерии включения

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

Критерии исключения

• allergic skin reaction to chest strap

Критерии приведены из реестра в оригинале (на английском). Окончательную оценку соответствия проводит исследовательский центр.

Здоровые добровольцы: Нет

Дизайн исследования

Модель наблюдения

Только случаи

Центры проведения

Норвегия · 1 центр

• University of Oslo — Oslo

Публикации

• Kildal ESM, Quintana DS, Szabo A, Tronstad C, Andreassen O, Naerland T, Hassel B. Heart rate monitoring to detect acute pain in non-verbal patients: a study protocol for a randomized controlled clinical trial. BMC Psychiatry. 2023 Apr 14;23(1):252. doi: 10.1186/s12888-023-04757-1. PMID 37060049
• Kildal E, Stadskleiv K, Boysen ES, Oderud T, Dahl IL, Seeberg TM, Guldal S, Strisland F, Morland C, Hassel B. Increased heart rate functions as a signal of acute distress in non-communicating persons with intellectual disability. Sci Rep. 2021 Mar 19;11(1):6479. doi: 10.1038/s41598-021-86023-6. PMID 33742078

Идентификаторы

NCT: NCT04199299 · Understand me!

Первоисточники (государственные реестры)

• ClinicalTrials.gov (NIH, США)

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