Sensors for Communication for Persons Who Cannot Communicate Unequivocally
Trial statusRecruiting
Trial phaseNot listed
Trial typeObservational
Biological sexAll
Age5-80
SponsorUniversity of Oslo
About this trial
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.
Eligibility criteria
This trial does not accept healthy volunteersQualifiers
intellectual disability with or without autism and/or cerebral palsy that render the participant unable to communicate his/her needs and reactions unequivocally.
Disqualifiers
allergic skin reaction to chest strap
Trial 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.
Trial design
Design model
Case-only
Time perspective
Prospective
Treatments tested in this trial
Heart rate and respiration rate sensors
DeviceThe 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.
Treatment groups
100 Participants
are divided into 1 treatment groupGroup A: Persons who cannot communicate unequivocally1 intervention
Trial outcomes
Primary outcomes
1
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.
Time frame
10 yearsSecondary outcomes
1
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.
Time frame
10 yearsOther outcomes
1
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.
Time frame
10 yearsSponsors and contacts
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Source ClinicalTrials.gov