Ignite Creation Date:
2025-12-24 @ 7:45 PM
Ignite Modification Date:
2026-02-21 @ 4:09 AM
Study NCT ID:
NCT04836403
Status:
COMPLETED
Last Update Posted:
2021-08-05
First Post:
2021-03-29
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Validation of the Chinese Version of the Sinus and Nasal Quality of Life Survey (SN-5)
Sponsor:
China Medical University Hospital
Organization:
Study Overview
Official Title:
Validation of the Chinese Version of the Sinus and Nasal Quality of Life Survey (SN-5) and Correlation With Pediatric Obstructive Sleep Apnea and Asthma
Status:
COMPLETED
Status Verified Date:
2021-08
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
Not Stopped
Has Expanded Access:
False
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
None
Brief Summary:
The purpose of our study was to validate the Chinese version of the Sinus and Nasal Quality of Life Survey (SN-5)and correlation with the incidence of pediatric obstructive sleep apnea and asthma.
The study will enroll pediatric patients of rhino-sinusitis and their parents to finish Questionnaire 1, including Chinese version of SN-5, visual analogue scale (VAS), Pediatric allergy disease Pediatric Allergic Disease Quality of Life Questionnaire (PADQLQ), OSA-18 quality of Life Survey, and asthma-diagnostic questionnaire . Some patients re-tested SN-5 in 1 week later. After four weeks, participants finish these questionnaire 2, including SN-5, VAS, and PADQLQ. In addition, the author will invite health children without rhino-sinusitis disease and their parents to fill in Questionnaire 1. The Chinese version of SN-5 will be validated to establish its reliability and validity.
The study will enroll pediatric patients of rhino-sinusitis and their parents to finish Questionnaire 1, including Chinese version of SN-5, visual analogue scale (VAS), Pediatric allergy disease Pediatric Allergic Disease Quality of Life Questionnaire (PADQLQ), OSA-18 quality of Life Survey, and asthma-diagnostic questionnaire . Some patients re-tested SN-5 in 1 week later. After four weeks, participants finish these questionnaire 2, including SN-5, VAS, and PADQLQ. In addition, the author will invite health children without rhino-sinusitis disease and their parents to fill in Questionnaire 1. The Chinese version of SN-5 will be validated to establish its reliability and validity.
Detailed Description:
The purpose of the study was to validate the Chinese version of the Sinus and Nasal Quality of Life Survey (SN-5)and correlation with the incidence of pediatric obstructive sleep apnea and asthma.
The study will enroll pediatric patients of rhino-sinusitis and parents to finish Questionnaire 1, including Chinese version of SN-5, visual analogue scale (VAS), Pediatric allergy disease Pediatric Allergic Disease Quality of Life Questionnaire (PADQLQ), OSA-18 quality of Life Survey, and asthma-diagnostic questionnaire . Some patients re-tested SN-5 in 1 week later. After four weeks, they finish these questionnaire 2, including SN-5, VAS, and PADQLQ. In addition, the author will invite health children without rhino-sinusitis disease and their parents to fill in Questionnaire 1. The Chinese version of SN-5 will be validated to establish its reliability and validity.
From December 2016 to December 2017, healthy volunteers and children with persistent sinonasal symptoms were enrolled. Guardians of the participants completed the SN-5, a visual analog scale (VAS) of nasal symptoms, and the Obstructive Sleep Apnea-18 (OSA-18) ; the responses were used to assess internal consistency, discriminant validity, and treatment responsiveness. A nontreatment group was administered the SN-5 1 week later to assess test-retest reliability.
The study will enroll pediatric patients of rhino-sinusitis and parents to finish Questionnaire 1, including Chinese version of SN-5, visual analogue scale (VAS), Pediatric allergy disease Pediatric Allergic Disease Quality of Life Questionnaire (PADQLQ), OSA-18 quality of Life Survey, and asthma-diagnostic questionnaire . Some patients re-tested SN-5 in 1 week later. After four weeks, they finish these questionnaire 2, including SN-5, VAS, and PADQLQ. In addition, the author will invite health children without rhino-sinusitis disease and their parents to fill in Questionnaire 1. The Chinese version of SN-5 will be validated to establish its reliability and validity.
From December 2016 to December 2017, healthy volunteers and children with persistent sinonasal symptoms were enrolled. Guardians of the participants completed the SN-5, a visual analog scale (VAS) of nasal symptoms, and the Obstructive Sleep Apnea-18 (OSA-18) ; the responses were used to assess internal consistency, discriminant validity, and treatment responsiveness. A nontreatment group was administered the SN-5 1 week later to assess test-retest reliability.
Study Oversight
Has Oversight DMC:
False
Is a FDA Regulated Drug?:
False
Is a FDA Regulated Device?:
False
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
None
Is an FDA AA801 Violation?: