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临床试验/NCT06141707
NCT06141707尚未招募不适用

Adaptation and Validation of Pediatric Sleep Questionnaire (PSQ) in Arabic

Minia University0 个研究点目标入组 152 人开始时间: 2025年1月最近更新:
适应症

试验速览

阶段
不适用
状态
尚未招募
发起方
入组人数
152
主要终点
total score

研究概览

简要总结

The gold-standard in the diagnosis of Sleep-Related Breathing Disorders (SRBDs) is polysomnography, but the time, effort, and expense of laboratory studies has limited relevant research and particularly epidemiological research that requires large samples. Research in adults has profited from the existence of several validated questionnaire instruments to assess for Sleep-Related Breathing Disorders (SRBDs) or related symptoms. Pediatric Sleep Questionnaire (PSQ) developed and validated by chervil et al. (2000) is a 22 item questionnaire which had been shown to have a sensitivity of 81% and specificity of 87% for SRBDs.

In this study 152 parents in charge of children and adolescents with and without SRBDs aged from 2 years to 18 years, will participate. collection of the study sample will take place in Phoniatric clinic and otolaryngology clinic, minna University Hospital. This sample will be divided into three groups: G1, G2, and G3.

The validation of the Arabic Pediatric Sleep Questionnaire (APSQ) will be executed in many stages:

  1. Translation, linguistic and cultural adaptation with bilingual Phoniatrician and qualified translator who will perform translation and back translation.
  2. Pilot study with the application of the translated version on a group of SRBDs participants "20 children and adolescents with SRBDs ".
  3. History will be taken from all groups.
  4. Application of the survey in its final version on participants with and without SRBDs.

详细描述

The gold-standard in the diagnosis of Sleep-Related Breathing Disorders (SRBDs) is polysomnography, but the time, effort, and expense of laboratory studies has limited relevant research and particularly epidemiological research that requires large samples. Research in adults has profited from the existence of several validated questionnaire instruments to assess for SRBDs or related symptoms .

Pediatric Sleep Questionnaire (PSQ) developed and validated by chervil et al. (2000) is a 22 item questionnaire which had been shown to have a sensitivity of 81% and specificity of 87% for SRBDs.

This study aims at performing the validation of the Arabic version of the Pediatric Sleep Questionnaire (PSQ), called Arabic Pediatric Sleep Questionnaire (APSQ) by means of translation and cultural adaptation of the instrument and by obtaining psychometric measures of validity and reliability, to verify if the presence of childhood SRBDs and prominent symptom complexes, including snoring, daytime sleepiness, and related behavioral disturbances and to obtain normal scores for pediatric population as regard the APSQ.

In this study 152 parents in charge of children and adolescents with and without SRBDs aged from 2 years to 18 years, will participate. collection of the study sample will take place in Phoniatric clinic and otolaryngology clinic, minna University Hospital. This sample will be divided into three groups: G1, G2, and G3.

The validation of the Arabic Pediatric Sleep Questionnaire (APSQ) will be executed in many stages:

研究设计

研究类型
Observational
观察模型
Other
时间视角
Prospective

入排标准

年龄范围
2 Years 至 18 Years(Child, Adult)
性别
All
接受健康志愿者

入选标准

  • children with obstructive sleep apnea.
  • Age is from 2 to 18 years.

排除标准

  • Presence of acute infection in the upper airway.
  • Previous treatment.
  • Previously diagnosed neurological or psychiatric disorder

结局指标

主要结局

total score

时间窗: baseline

total score in degree

次要结局

未报告次要终点

研究者

发起方
Minia University
申办方类型
Other
责任方
Principal Investigator
主要研究者

Wafaa Helmy Abdelhakeem

Principal Investigator

Minia University

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