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

Sponsor
Minia University (Other)
Overall Status
Not yet recruiting
CT.gov ID
NCT06141707
Collaborator
(none)
152
3

Study Details

Study Description

Brief Summary

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.

Condition or Disease Intervention/Treatment Phase
  • Other: Arabic pediatric sleep questionnaire

Detailed Description

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:

  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.

Study Design

Study Type:
Observational
Anticipated Enrollment :
152 participants
Observational Model:
Other
Time Perspective:
Prospective
Official Title:
Adaptation and Validation of Pediatric Sleep Questionnaire (PSQ) in Arabic
Anticipated Study Start Date :
Dec 1, 2023
Anticipated Primary Completion Date :
Feb 1, 2024
Anticipated Study Completion Date :
Mar 1, 2024

Arms and Interventions

Arm Intervention/Treatment
Group I

G1 is comprised of 20 parents in charge of children and adolescents with SRBDs who will participate in pilot study.

Other: Arabic pediatric sleep questionnaire
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

Group II

G2 132 parents in charge of children and adolescents with and without SRBDs who will answer the final version of the protocol. This group will include 66 parents in charge of participants with SRBDs and 66 parents in charge of participants without SRBDs.

Other: Arabic pediatric sleep questionnaire
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

Group III

G3 is the group that will be used to test the reliability of the Arabic Pediatric Sleep Questionnaire (APSQ); 33 parents in charge will be randomly selected among the 66 parents in charge of subjects with SRBDs in G2.

Other: Arabic pediatric sleep questionnaire
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

Outcome Measures

Primary Outcome Measures

  1. total score [baseline]

    total score in degree

Eligibility Criteria

Criteria

Ages Eligible for Study:
2 Years to 18 Years
Sexes Eligible for Study:
All
Accepts Healthy Volunteers:
Yes
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

Contacts and Locations

Locations

No locations specified.

Sponsors and Collaborators

  • Minia University

Investigators

  • Study Director: Fatma W Shahin, MD, Minia University

Study Documents (Full-Text)

None provided.

More Information

Publications

None provided.
Responsible Party:
Wafaa Helmy Abdelhakeem, Principal Investigator, Minia University
ClinicalTrials.gov Identifier:
NCT06141707
Other Study ID Numbers:
  • Arabic Validation of PSQ
First Posted:
Nov 21, 2023
Last Update Posted:
Nov 21, 2023
Last Verified:
Nov 1, 2023
Individual Participant Data (IPD) Sharing Statement:
Undecided
Plan to Share IPD:
Undecided
Studies a U.S. FDA-regulated Drug Product:
No
Studies a U.S. FDA-regulated Device Product:
No
Keywords provided by Wafaa Helmy Abdelhakeem, Principal Investigator, Minia University
Additional relevant MeSH terms:

Study Results

No Results Posted as of Nov 21, 2023