Assesment of Olfactory Disorders and Performance of a New Olfactory Test in Children With Congenital CMV

NCT ID: NCT02782988

Last Updated: 2021-07-27

Basic Information

• Recruitment Status: COMPLETED
• Total Enrollment: 106 participants
• Study Classification: OBSERVATIONAL
• Study Start Date: 2016-05-31
• Study Completion Date: 2020-05-02

Brief 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.

Conditions

Congenital Cytomegalovirus Infection

Study Design

• Observational Model Type: CASE_CONTROL
• Study Time Perspective: CROSS_SECTIONAL

Study Groups

CMV symptomatic at birth

olfactory tests, otoacoustic emissions (OAE)

olfactory tests, otoacoustic emissions (OAE)

Intervention Type: OTHER

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.

CMV asymptomatic at birth

olfactory tests, otoacoustic emissions (OAE)

olfactory tests, otoacoustic emissions (OAE)

Intervention Type: OTHER

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.

Healthy controls

olfactory tests, otoacoustic emissions (OAE)

olfactory tests, otoacoustic emissions (OAE)

Intervention Type: OTHER

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.

Interventions

olfactory tests, otoacoustic emissions (OAE)

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.

Intervention Type: OTHER

Eligibility Criteria

Inclusion Criteria

• Children ≥ 3 years old and ≤ 10 years old
• Oral consent of the child to participate in the study
• Written informed consent of the two parents
• Congenital CMV infection : 1) asymptomatic form at birth and 2) symptomatic form at birth. The latter is defined by the presence of at least one of the following clinical signs: growth retardation, prematurity,petechiae, splenomegaly, thrombocytopenia, jaundice, low number of platelets, ictere, digestive disorders ...

NOTE: CMV diagnosis is made on the following criteria: positive CMV PCR in urine and / or blood in the first 3 weeks of life or retrospective diagnosis on the presence of a positive PCR on the Guthrie test performed at 3-7 days of life.

Exclusion Criteria

• Medical care incompatible with the objective of the study,
• Patient who would object to the protocol
• No clinical condition that may interfere with the study, e.g.: no chronic sinusitis, nasopharyngitis, etc.

• Minimum Eligible Age: 3 Years
• Maximum Eligible Age: 10 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: Yes

Sponsors

Institut Pasteur

INDUSTRY

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Principal Investigators

Françoise LAZARINI, PhD

Role: STUDY_DIRECTOR

Institut Pasteur, Paris France

Locations

Hopital Bicêtre

Le Kremlin-Bicêtre, , France

Robert Debré Hospital

Paris, , France

Countries

France

Other Identifiers

2015-091

Identifier Type: -

Identifier Source: org_study_id