To assess the feasibility of using the U-SNIFF in various European countries (e.g. the Netherlands). To validate the developed odor identification test for children (U-SNIFF), in various European countries. (e.g. the Netherlands). To assess the test…
ID
Source
Brief title
Condition
- Other condition
Synonym
Health condition
geen aandoeningen: zintuigelijk onderzoek naar het reukvermogen
Research involving
Sponsors and support
Intervention
Outcome measures
Primary outcome
Odor identification scores (total amount of correct answers) at the first and
second test session.
Secondary outcome
n/a
Background summary
Tools for measuring olfactory function in adults have been well established.
Although studies have shown that olfactory impairment in children may occur as
a consequence of a number of diseases or head trauma, until today no consensus
on how to evaluate the sense of smell in children exists in Europe. To
determine childrens' smell function, recently an odor identification test has
been developed in Germany (U-SNIFF). However, no cross-cultural validation has
been done to assess its use in other countries within and outside of Europe.
Study objective
To assess the feasibility of using the U-SNIFF in various European countries
(e.g. the Netherlands).
To validate the developed odor identification test for children (U-SNIFF), in
various European countries. (e.g. the Netherlands).
To assess the test-retest reliability of the U-SNIFF.
Study design
This protocol is part of a larger multicenter study, including Argentina,
Brazil, China, Iran, the Netherlands, Norway, Oman, the Philippines, Rumania,
Russia, Thailand, and is headed by Uniklikum TU Dresden, Germany. This is an
observational study, that will twice measure olfactory function in children.
Duration of each test session will be approximately 15-30-minutes; the test
sessions will be at least two days apart.
The smell test consists of 12 pens filled with the following odors: apple,
banana, butter, coffee, grass, fish, rose, lemon, onion, orange, peach,
strawberry.
Study burden and risks
This is a group-related study: participation of the children is essential in
this study, since the purpose of the study is to validate an odor
identification test for use in children. Results for adults cannot be
extrapolated to children. The study is non-therapeutic to the participant. The
risk of participating in the study is negligible and the burden of
participating is minimal. The total study duration will be maximally 60minutes
per participant and consist of smelling every-day odors. Odors will be used in
concentrations that can be found in consumer products, that are non-toxic
and/or can be considered safe.
Stippeneng 4
Wageningen 6708 WE
NL
Stippeneng 4
Wageningen 6708 WE
NL
Listed location countries
Age
Inclusion criteria
children, aged 6, 7, or 8 years
Self-reported normal sense of smell
Permission from their parents to participate
Willing to participate
Exclusion criteria
- Known smell dysfunction
- Disease that is known to influence the sense of smell (e.g. renal failure, epilepsy)
- Acute and chronic rhinosinusitis/sinusitis
- Has known allergic or aversive reactions to certain odors
Design
Recruitment
Followed up by the following (possibly more current) registration
No registrations found.
Other (possibly less up-to-date) registrations in this register
No registrations found.
In other registers
| Register | ID |
|---|---|
| CCMO | NL63829.081.17 |