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Clinical Trial Details — Status: Completed

Administrative data

NCT number NCT04836403
Other study ID # CMUH105-REC1-138(AR-1)
Secondary ID
Status Completed
Phase
First received
Last updated
Start date December 1, 2016
Est. completion date December 31, 2017

Study information

Verified date August 2021
Source China Medical University Hospital
Contact n/a
Is FDA regulated No
Health authority
Study type Observational

Clinical Trial 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.


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.


Recruitment information / eligibility

Status Completed
Enrollment 116
Est. completion date December 31, 2017
Est. primary completion date December 31, 2017
Accepts healthy volunteers Accepts Healthy Volunteers
Gender All
Age group 2 Years to 12 Years
Eligibility Inclusion Criteria: Children with one or more of the following symptoms, purulent nasal discharge, nasal congestion, cough, or postnasal drip for at least 1 month. Exclusion Criteria: - craniofacial anomalies - cognitive deficits - illiteracy in traditional Chinese.

Study Design


Related Conditions & MeSH terms


Intervention

Other:
Sinus and nasal quality of life survey questionnaire (SN-5)
The SN-5 consists of five questions on a 7-point scale that assesses the frequency of the following symptoms: (1) nasal obstruction, (2) sinus infection, (3) allergies, (4) emotional distress, and (5) activity limitations. The scoring system is as follows: 1 indicates "none of the time," 2 indicating "hardly any time at all," 3 indicates "a small part of the time," 4 indicates "some of the time," 5 indicates "a good part of the time," 6 indicates "most of the time," and 7 indicates "all of the time." Higher scores indicate more severe sinonasal symptoms. One item from a global faces scale scored from 0 to 10 is used to evaluate overall QoL related to nasal or sinus disease. Higher scores on this scale indicate a less severe impact of nasal or sinus disease. The scores from the first five items (1-7 each)

Locations

Country Name City State
n/a

Sponsors (1)

Lead Sponsor Collaborator
China Medical University Hospital

Outcome

Type Measure Description Time frame Safety issue
Primary Test-retest reliability A nontreatment group was administered the SN-5 1 week later to assess test-retest reliability. 1 week
Primary Concurrent validity The correlation between SN-5 and VAS scores was used to analyze the concurrent validity of the SN-5. baseline
Primary Discriminant validity Discriminant validity was assessed by calculating the difference between the SN-5 scores for participants with rhinosinusitis and for the healthy participants. These differences were analyzed with the Mann-Whitney U test. baseline
Secondary the mean scores of SN-5 To evaluate the responsiveness of the treatment , the author compare the mean score of treatment group after 4-week-treatment compared to baseline mean score of SN-5 before treatment.Data analyzed with the Wilcoxon signed-rank test. Effects were evaluated through intention-to-treat analysis. 4 week
Secondary correlation with score of SN-5 and score of OSA-18 quality of life questionnaire (OSA-18) To evaluate the correlation of SN-5 and OSA-18, Spearman correlation coefficients between the SN-5 and OSA-18 scores were analyzed. baseline and 4 week
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