Sensors for Communication for Persons Who Cannot Communicate Unequivocally

The Use of Sensors to Improve Communication for Persons With Intellectual Disability 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.

Study Overview

• Status: Recruiting
• Conditions: Cerebral Palsy; Intellectual Disability; Autism
• Intervention / Treatment: Device: Heart rate and respiration rate sensors

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.

• Study Type: Observational
• Enrollment (Estimated): 100

Contacts and Locations

• Study Contact: Name: Bjørnar Hassel, PhD; Phone Number: 004798829754; Email: bjornar.hassel@medisin.uio.no
• Study Contact Backup: Name: Emilie SM Kildal; Phone Number: 004745481949; Email: eskildal@sv.uio.no

Study Locations

• Norway
  • Oslo, Norway, 0450
    • Recruiting
    • University of Oslo
    • Contact: Bjørnar Hassel, PhD; Phone Number: 004798829754; Email: bjornar.hassel@medisin.uio.no
    • Contact: Emilie SM Kildal; Phone Number: 004745481949; Email: eskildal@sv.uio.no

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 5 years to 80 years (Child, Adult, Older Adult)
• Accepts Healthy Volunteers: No

• 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.

Description

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

Study Plan

How is the study designed?

Number of groups / cohorts

1

Cohorts and Interventions

Group / Cohort

Intervention / Treatment

Persons who cannot communicate unequivocally; Persons with intellectual disability, childhood autism, and/or cerebral palsy who cannot communicate unequivocally and therefore cannot communicate their needs and wishes, e.g. whether they are uncomfortable, in pain, scared, angry, happy, pleased.

Device: 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.

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Caregivers' practice detailed in structured interview	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.	10 years

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Caregivers' understanding of the user detailed in structured interview	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.	10 years

Other Outcome Measures

Outcome Measure	Measure Description	Time Frame
Frequency of self harm or aggressive behavior measured by daily registration	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.	10 years

Collaborators and Investigators

• Sponsor: University of Oslo
• Investigators: Principal Investigator: Bjørnar Hassel, PhD, University of Oslo

Publications and helpful links

General Publications

• 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.
• 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.

Helpful Links

• First published article from the study

Study record dates

Study Major Dates

• Study Start (Actual): February 1, 2020
• Primary Completion (Estimated): December 31, 2030
• Study Completion (Estimated): December 31, 2032

Study Registration Dates

• First Submitted: April 25, 2019
• First Submitted That Met QC Criteria: December 12, 2019
• First Posted (Actual): December 13, 2019

Study Record Updates

• Last Update Posted (Actual): February 20, 2024
• Last Update Submitted That Met QC Criteria: February 16, 2024
• Last Verified: February 1, 2024

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Mental Disorders; Brain Diseases; Central Nervous System Diseases; Nervous System Diseases; Neurologic Manifestations; Neurobehavioral Manifestations; Brain Damage, Chronic; Neurodevelopmental Disorders; Cerebral Palsy; Intellectual Disability
• Other Study ID Numbers: Understand me!

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No