Pilot study to investigate the value of sensors for early allergic response detection during a food challenge and drug provocation test.

Pilot study to investigate the value of sensors for early allergic response detection during a food challenge and drug provocation test. - Sensors for Early Allergic response Detection

Status

Active, not recruiting

Phases

Unknown

Study type

Observational

Source

NL-OMON

Registry ID

NL-OMON49920

Enrollment

Registered

2021-08-18

Start date

2021-10-27

Completion date

Unknown

Last updated

2024-04-15

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

Conditions

drug allergy Food Allergy

Interventions

None listed

Eligibility

Age

18 Years to 64 Years

Inclusion criteria

Inclusion criteria: In order to be eligible to participate in this study, a subject must meet the following criteria: o Undergo a food challenge in routine care o At least 18 years of age at the start of the study o Written informed consent

Exclusion criteria

Exclusion criteria: A potential subject who meets any of the following criteria will be excluded from participation in this study: o

Design outcomes

Primary

Measure	Time frame
The primary endpoint is: Change in continuous heart rate, respiratory rate, axillary temperature, non-invasive blood pressure and oxygen saturation between baseline and verum day and when applicable between placebo and verum day.	—

Secondary

Measure	Time frame
The secondary endpoint is: The time that a change in continuous heart rate, respiratory rate, axillary temperature, non-invasive blood pressure and oxygen saturation is seen, before the report of complaints by patient	—

Countries

Netherlands

Outcome results