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NCT Number: NCT04199299

Sensors for Communication for Persons Who Cannot Communicate Unequivocally

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.

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Key information

Conditions

Intellectual Disability Autism Autism Spectrum Disorder Autistic Disorder Brain Damage, Chronic Brain Diseases Central Nervous System Diseases Cerebral Palsy Child Development Disorders, Pervasive Mental Disorders Nervous System Diseases Neurobehavioral Manifestations Neurodevelopmental Disorders Neurologic Manifestations Pathological Conditions, Signs and Symptoms Signs and Symptoms

Age range

5 year–80 year

Sex eligibility

All sexes

Study type

Observational

Primary location

About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

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

Exclusion criteria

  • allergic skin reaction to chest strap

Treatment and study plan

Heart rate and respiration rate sensors

Device

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.

Primary outcomes

  1. Caregivers' practice detailed in structured interview

    Time frame: 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.

Secondary outcomes

  1. Caregivers' understanding of the user detailed in structured interview

    Time frame: 10 years

    Does introduction of pulse- and respiration sensors to allow participants to communicate pain, anxiety, sleeplessness etc., change caregivers' understanding of the participants' situation, needs and personality? These questions are addressed in a structured interview with caregivers prior to and 2 months after the introduction of pulse- and respiration sensors.

Other outcomes

  1. Frequency of self harm or aggressive behavior measured by daily registration

    Time frame: 10 years

    Self harm and aggressive behavior are registered daily in the participants' dwellings, offering a means of comparing the frequency of such behavior before and after the introduction of pulse - and respiration sensors.

Study contacts

Contact information is provided by the study sponsor or research team.

Bjørnar Hassel, PhD

CONTACT

[email protected]

004798829754

Emilie SM Kildal

CONTACT

[email protected]

004745481949

Sponsors and collaborators

Lead sponsor

University of Oslo

Other

Registry information

Official study title

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

Important dates

Study start
2020
Primary completion
2030
Study completion
2032
First posted
Dec 13, 2019
Registry last updated
Jul 4, 2025

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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