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Wearable cough registration to assess children’s asthma control

Wearable cough registration to assess children’s asthma control

Status
Active, not recruiting
Phases
Unknown
Study type
Observational
Source
NL-OMON
Registry ID
NL-OMON20576
Enrollment
30
Registered
2018-07-10
Start date
2018-07-15
Completion date
Unknown
Last updated
2024-06-11

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Asthma, Bronchial hyperresponsiveness, Children, Astma, Bronchiale Hyperreactiviteit, Kinderen.

Interventions

- Wearing several devices
an accelerometer for 4 times 12 consecutive hours to measure cough sounds, an accelerometer to monitor physical activity for a full week an wearing of an ECG-device during phsyical activity. - Using
the C-ACT, the PAQLQ and a custom questionnaire to evaluate the use of an accelerometer in a non-conventional way.

Sponsors

MST Enschede
Lead Sponsor

Eligibility

Inclusion criteria

Inclusion criteria: In order to be eligible to participate in this study, a subject must meet all of the following criteria: • Children with paediatrician diagnosed asthma, or children whom are suspected to suffer from asthma, based on reported symptoms, atopy and physical examination performed by a physician. • Children aged between 4 and 14 years old. • Children whom will receive an ECT.

Exclusion criteria

Exclusion criteria: A potential subject who meets any of the following criteria will be excluded from participation in this study: • Children who are unable to speak Dutch, or whose legal guardians are unable to speak Dutch. • Children for whom it is not possible to wear all wearables. For example due to severe skin disease or an amputation of the arm. • Children with implanted electrical stimulating devices. • Children with a known band-aid allergy. • Children with psychomotor retardation. • Children with chronic diseases (other than asthma). • Children whom were born prematurely (≤ 37 weeks).

Design outcomes

Secondary

MeasureTime frame
The secondary parameters of this study yield: - The correlation between the cough sound parameters and asthma control based on the FOT measurements. FOT based asthma control will be defined as in the statement of the ATS and ERS.67 - The willingness to take part in this study, reflected by the amount of accepted invitations to take part in this study and the amount of invitations send to participate in this study. • The experience of the patients with wearing the cough measuring device in a non-conventional way, reflected by a questionnaire about the GENEActiv device. - The correlation of coughs and it’s parameters measured by the GENEActiv device and by sound recordings. - The change in the cough parameters as a function of FEV1, as measured at home. - The correlation between voluntary and involuntary coughs, measured in a clinical environment. - The correlation between in-home measured voluntary and involuntary coughs. - The correlation of coughs measured by two different accelerometers with different sample frequencies (100 Hz versus 1000 Hz). - The correlation between the perceived asthma control, as determined by the C-ACT and PAQLQ, and the amount of coughs exerted during the day and during the night. - The in-patient variances in cough parameters and their accompanying FEV1, due to sleeping. - The in-patient variances in cough parameters and their accompanying FEV1, due to inhalation of a SABA.

Primary

MeasureTime frame
The main study parameter is to correlate the cough sound parameters to ECT-determined asthma control, reflected by the behaviour of the FEV1 during the ECT.

Contacts

Public ContactE.C. Klaver
e.c.klaver@student.utwente.nl

Outcome results

None listed

Source: NL-OMON (via WHO ICTRP)