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NCT Number: NCT06141707

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

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.

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Key information

About this study

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:

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

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

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

Exclusion criteria

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

Treatment and study plan

Arabic pediatric sleep questionnaire

Other

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 SRBD.These scales for childhood SRBDs, snoring, sleepiness, and behavior are valid and reliable instruments that can be used to identify SRBDs or associated symptom-constructs in clinical research when polysomnography is not feasible.

Primary outcomes

  1. total score

    Time frame: baseline

    total score in degree

Study contacts

Contact information is provided by the study sponsor or research team.

Wafaa H Abdelhakeem, MD

CONTACT

[email protected]

01091813874

Sponsors and collaborators

Lead sponsor

Minia University

Other

Registry information

Important dates

Study start
2025
Primary completion
2025
Study completion
2025
First posted
Nov 21, 2023
Registry last updated
Dec 10, 2024

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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