- ICH GCP
- US Clinical Trials Registry
- Clinical Trial 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:
- 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.
Study Overview
Status
Conditions
Intervention / Treatment
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:
- 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.
Study Type
Enrollment (Estimated)
Contacts and Locations
Study Contact
- Name: Wafaa H Abdelhakeem, MD
- Phone Number: 01091813874
- Email: dr.fofahma@gmail.com
Participation Criteria
Eligibility Criteria
Ages Eligible for Study
- Child
- Adult
Accepts Healthy Volunteers
Sampling Method
Study Population
Description
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
Study Plan
How is the study designed?
Design Details
Cohorts and Interventions
Group / Cohort |
Intervention / Treatment |
|---|---|
|
OSA group
This group will include 66 parents in charge of participants with SRBDs.
|
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.
|
|
reliability group
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 OSA group.
|
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.
|
|
control group
control group will include 66 children with no OSA
|
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.
|
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
|---|---|---|
|
total score
Time Frame: baseline
|
total score in degree
|
baseline
|
Collaborators and Investigators
Sponsor
Investigators
- Study Director: Fatma W Shahin, MD, Minia university
Publications and helpful links
Study record dates
Study Major Dates
Study Start (Estimated)
Primary Completion (Estimated)
Study Completion (Estimated)
Study Registration Dates
First Submitted
First Submitted That Met QC Criteria
First Posted (Actual)
Study Record Updates
Last Update Posted (Estimated)
Last Update Submitted That Met QC Criteria
Last Verified
More Information
Terms related to this study
Additional Relevant MeSH Terms
Other Study ID Numbers
- Arabic Validation of PSQ
Plan for Individual participant data (IPD)
Plan to Share Individual Participant Data (IPD)?
Drug and device information, study documents
Studies a U.S. FDA-regulated drug product
Studies a U.S. FDA-regulated device product
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