Outcome
Type |
Measure |
Description |
Time frame |
Safety issue |
Primary |
Sinonasal symptoms and signs |
Prevalence of reported clinical symptoms at different age groups, including rhinitis, sinusitis, snoring |
at baseline |
|
Primary |
Course of sinonasal symptoms and signs (year 1) |
Change from baseline prevalence of reported clinical symptoms at different age groups, including rhinitis, sinusitis, snoring, at 12 months |
at 12 months from recruitment |
|
Primary |
Course of sinonasal symptoms and signs (year 2) |
Change from baseline prevalence of reported clinical symptoms at different age groups, including rhinitis, sinusitis, snoring, at 24 months |
at 24 months from recruitment |
|
Primary |
Otological symptoms and signs |
Prevalence of reported clinical symptoms at different age groups, including ear pain, hearing problems, ear discharge |
at baseline |
|
Primary |
Course of otological symptoms and signs (year 1) |
Change from baseline prevalence of reported clinical symptoms at different age groups, including ear pain, hearing problems, ear discharge, at 12 months |
at 12 months from recruitment |
|
Primary |
Course of otological symptoms and signs (year 2) |
Change from baseline prevalence of reported clinical symptoms at different age groups, including ear pain, hearing problems, ear discharge, at 24 months |
at 24 months from recruitment |
|
Primary |
Nasal endoscopy (description of nasal mucosa) |
Description of nasal mucosa as seen via nasal endoscopy examination |
at baseline |
|
Primary |
Nasal endoscopy (changes of nasal mucosa at year 1) |
Changes in nasal mucosa from baseline as seen via nasal endoscopy examination at 12 months |
at 12 months from recruitment |
|
Primary |
Nasal endoscopy (changes of nasal mucosa at year 2) |
Changes in nasal mucosa from baseline as seen via nasal endoscopy examination at 24 months |
at 24 months from recruitment |
|
Primary |
Nasal endoscopy (nasal polyps) |
Prevalence of nasal polyps at baseline |
at baseline |
|
Primary |
Nasal endoscopy (nasal polyps at year 1) |
Changes in prevalence of nasal polyps from baseline to 12 months |
at 12 months from recruitment |
|
Primary |
Nasal endoscopy (nasal polyps at year 2) |
Changes in prevalence of nasal polyps from baseline to 24 months |
at 24 months from recruitment |
|
Primary |
Sinonasal examination (Lidholdt score) |
Lidholdt score at baseline |
at baseline |
|
Primary |
Sinonasal examination (Lidholdt score at year 1) |
Changes in Lidholdt score from baseline to 12 months |
at 12 months from recruitment |
|
Primary |
Sinonasal examination (Lidholdt score at year 2) |
Changes in Lidholdt score from baseline to 24 months |
at 24 months from recruitment |
|
Primary |
Ear examination (ear discharge) |
Prevalence of ear discharge at baseline |
at baseline |
|
Primary |
Ear examination (ear discharge at year 1) |
Changes in prevalence of ear discharge from baseline to 12 months |
at 12 months from recruitment |
|
Primary |
Ear examination (ear discharge at year 2) |
Changes in prevalence of ear discharge from baseline to 24 months |
at 24 months from recruitment |
|
Primary |
Otoscopy (description of the tympanic membrane) |
Description of tympanic membrane as seen via otoscopy examination |
at baseline |
|
Primary |
Otoscopy (description of the tympanic membrane at year 1) |
Changes in the tympanic membrane from baseline to 12 months as seen via otoscopy examination |
at 12 months from recruitment |
|
Primary |
Otoscopy (description of the tympanic membrane at year 2) |
Changes in the tympanic membrane from baseline to 24 months as seen via otoscopy examination |
at 24 months from recruitment |
|
Primary |
Tympanometry |
Results of tympanometry (tympanogram type for both ears) at baseline |
at baseline |
|
Primary |
Tympanometry (at year 1) |
Changes in tympanogram (for both ears) from baseline to 12 months |
at 12 months from recruitment |
|
Primary |
Tympanometry (at year 2) |
Changes in tympanogram (for both ears) from baseline to 24 months |
at 24 months from recruitment |
|
Primary |
Audiometry |
Results of audiometry: type of audiometry and results based on WHO hearing loss grades (for both ears) |
at baseline |
|
Primary |
Audiometry (at year 1) |
Changes in audiometry results from baseline to 12 months |
at 12 months from recruitment |
|
Primary |
Audiometry (at year 2) |
Changes in audiometry results from baseline to 24 months |
at 24 months from recruitment |
|