Clinical trial NCT04199299: Sensors for Communication for Persons Who Cannot Communicate Unequivocally
Official title: The Use of Sensors to Improve Communication for Persons With Intellectual Disability Who Cannot Communicate Unequivocally
Study type: OBSERVATIONAL
Overall status: RECRUITING
Conditions: Intellectual Disability
Autism
Cerebral Palsy
Lead sponsor: University of Oslo
Sponsor class: OTHER
First posted: 2019-12-13
Enrollment: 100
Sex: ALL
Minimum age (years): 5
Maximum age (years): 80
Standard ages: CHILD
ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: CASE_ONLY
Time perspective: PROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: Participants are persons with intellectual disability (ID) and/or cerebral palsy (CP) that render the participant unable to communicate unequivocally. Participants with ID will typically have severe (IQ score 20-35) or profound (IQ score \<20) ID. However, some may have moderate ID (IQ score 35-50) combined with autism of a degree that renders them unable to communicate unequivocally.

Participants with CP typically have a severe variant that implies impaired control over muscles involved in communication (speech, gaze direction, gesticulation, pointing, mimic/grimacing), rendering them unable to communicate unequivocally. However, some participants with CP may also have ID, which contributes to the communication difficulties.

Brief summary: 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.

Detailed description: 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.

Eligibility criteria: 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

Primary outcomes:
measure: Caregivers' practice detailed in structured interview
timeFrame: 10 years
Secondary outcomes:
measure: Caregivers' understanding of the user detailed in structured interview
timeFrame: 10 years
Other outcomes:
measure: Frequency of self harm or aggressive behavior measured by daily registration
timeFrame: 10 years
Locations:
city: Oslo
country: Norway
facility: University of Oslo
Study officials:
affiliation: University of Oslo
name: Bjørnar Hassel, PhD
role: PRINCIPAL_INVESTIGATOR
References:
citation: 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.
citation: 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.