NCT Number: NCT02380495
"Studio NaVA" - National Study on Quality of Life in Adolescents Affected by Allergic Rhinitis With or Without Asthma
"Studio Nava" is a National Study aiming to assess allergic rhinitis and asthma outcomes on Quality of Life and Quality of Sleep in adolescent patients by means of Web Survey. "Studio Nava" also proposes the innovative use of a web platform ("http://nava.ibim.cnr.it/") that contains all standardized tools (medical-healthcare web form, ACT, Asthma control test; PSQI, Pittsburgh Sleep Quality Index; T5SS, Total Symptom Score; modified SIDRIA for adolescents; Rhinasthma; VAS scale), that will be available for the doctors after the registration to the web platform. Downloaded questionnaires will be delivered to case-patient, asking him/her to fill them during the waiting time of the visit.
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Notify MeKey information
Conditions
Age range
14 year–17 year
Sex eligibility
All sexes
Study type
Observational
Primary location
Institute of Biomedicine and Molecular Immunology (IBIM), National Research Council, Palermo, Sicily, Italy
Who can participate
Healthy volunteers accepted: No
Only the study team can determine whether someone qualifies for participation.
Inclusion criteria
- Clinical cases n°: 600 adolescents affected by allergic rhinitis with/without asthma, from 14 to 17 years age.
- Controls n°: 600 subject (5 for each participant Pediatrician) of the same age range, without respiratory pathology.
Exclusion criteria
- Subjects that have not allergic rhinitis with/without asthma diagnosis or are <14 years old or >17 years old
Treatment and study plan
Primary outcomes
-
Assessment of the allergic rhinitis impact on quality of life
Time frame: 2 weeks
Secondary outcomes
-
The impact of AR and asthma on quality of sleep
Time frame: 2 weeks
Sponsors and collaborators
Lead sponsor
Stefania La Grutta, MD
Other
Registry information
Official study title
Studio NaVA - Studio Nazionale Sulla Qualità Della Vita in Adolescenti Con Rinite Allergica Con e Senza Asma
Important dates
- Study start
- 2015
- Primary completion
- 2017
- Study completion
- 2017
- First posted
- Mar 5, 2015
- Registry last updated
- May 19, 2017
OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.
View the official ClinicalTrials.gov record (opens in a new tab)This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.
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