Assesment of Olfactory Disorders and Performance of a New Olfactory Test in Children With Congenital CMV
Condition: Congenital Cytomegalovirus Infection
MeSH terms: Infections; Cytomegalovirus Infections
Study type: Observational

Summary: 
      CMV lesions were found in the olfactory system of children with congenital CMV infection but
      no study has hitherto examined the impact of congenital CMV infection on olfaction. So the
      investigators propose in this study to assess the proportion of children with olfactory
      deficits among children with congenital CMV infection. Second this study will also evaluate
      performances of a new olfactory test, based on discrimination of binary odorant mixtures.
    

Detailed description: 
      Cytomegalovirus (CMV) is the first cause of congenital deafness resulting from viral
      infection. Hearing loss may occur several years after birth in childhood and be often
      progressive. Detection of hearing impairment is of major interest for children because it
      will allow the early use of a hearing aid minimizing the impact of these deficits on the
      cognitive development.

      The study hypothesis is that a link might exist between hearing deficits and olfactory
      deficits in these children due to viral lesions on the two sensory systems. Thus early
      exploration of olfaction might allow early detection of starting deterioration of hearing or
      predict the occurrence of deafness. Moreover, this exploration is easy, non invasive, fast to
      set up and adapted to very young children. No study has hitherto assessed the impact of
      congenital CMV infection on olfaction.

      The proportion of children with olfactory deficits will be assessed among children with
      congenital CMV infection, using parts of a discrimination test of simple odorants (Sniffin'
      Sticks, Burghardt, Wedel, Germany). The performances of a new olfactory test developed by the
      investigators that uses binary mixtures of odorants, will also be assessed. These tests of
      nasal chemosensory performance are based on pen-like odor dispensing devices and measure odor
      discrimination ability of young children in less than 15 min. Finally, this study aims at
      demonstrate, if it exists, the association between olfactory deficits and hearing loss in
      children with congenital CMV infection.

      This study will be conducted in 80 patients and 40 healthy subjects (3-10years). The healthy
      children will be matched for age and gender. Selection will be made based on medical records
      during the course of standard care visit. After collection of informed consent, olfactory
      tests will be performed.
    

Intervention name(s): olfactory tests, otoacoustic emissions (OAE)
Intervention type(s): Other
Intervention description(s): Two series of olfactory tests will be performed : 1) the first one with simple odorants and 2) the second one with binary mixtures of odorants. These tests of nasal chemosensory performance are based on pen-like odor dispensing devices (Sniffin' Sticks, Burghardt, Wedel, Germany) and measure odor discrimination ability of young children in less than 15 min.
Observational model: Case-Control
Time perspective: Cross-Sectional
Sampling method: Non-Probability Sample
Study population: 
        80 children with congenital CMV infection will be included in a monocentre study : 40
        children which symptomatic CMV infection at birth and 40 children with asymptomatic form of
        infection at birth. To evaluate the performance of the new olfactory test, 40 controlled
        healthy children matched for age and gender will also be included.
      
Keywords: Olfaction; CMV