Sensors for Communication for Persons Who Cannot Communicate Unequivocally

Cerebral Palsy Clinical Trial

Official title:

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

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT04199299
• Other study ID #: Understand me!
• Status: Recruiting
• Start date: February 1, 2020
• Est. completion date: December 31, 2032

Study information

• Verified date: February 2024
• Source: University of Oslo
• Contact: Bjørnar Hassel, PhD
• Phone: 004798829754
• Email: bjornar.hassel[@]medisin.uio.no
• Is FDA regulated: No
• Study type: Observational

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 100
• Est. completion date: December 31, 2032
• Est. primary completion date: December 31, 2030
• Accepts healthy volunteers: No
• Gender: All
• Age group: 5 Years to 80 Years

Eligibility

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

Related Conditions & MeSH terms

• Autism
• Cerebral Palsy
• Intellectual Disability

Intervention

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.

Locations

Country	Name	City	State
Norway	University of Oslo	Oslo

Sponsors (1)

Lead Sponsor	Collaborator
University of Oslo

Country where clinical trial is conducted

Norway, 

References & Publications (2)

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. — View 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. — View Citation

Outcome

Type	Measure	Description	Time frame	Safety issue
Other	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
Primary	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	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