Clinical trial NCT06141707: Adaptation and Validation of Pediatric Sleep Questionnaire (PSQ) in Arabic
Official title: Adaptation and Validation of Pediatric Sleep Questionnaire (PSQ) in Arabic
Study type: OBSERVATIONAL
Overall status: NOT_YET_RECRUITING
Conditions: Obstructive Sleep Apnea
Keywords: obstructive sleep apnea, pediatric sleep questionnaire
Lead sponsor: Minia University
Sponsor class: OTHER
First posted: 2023-11-21
Enrollment: 152
Sex: ALL
Minimum age (years): 2
Maximum age (years): 18
Standard ages: CHILD
ADULT
Accepts healthy volunteers: yes
Observational model: OTHER
Time perspective: PROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: children diagnosed as obstructive sleep apnea

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.

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.

Eligibility criteria: 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

Primary outcomes:
measure: total score
timeFrame: baseline
Secondary outcomes:
Other outcomes:
Locations:
Study officials:
affiliation: Minia University
name: Fatma W Shahin, MD
role: STUDY_DIRECTOR
References:
citation: Chervin RD, Hedger K, Dillon JE, Pituch KJ. Pediatric sleep questionnaire (PSQ): validity and reliability of scales for sleep-disordered breathing, snoring, sleepiness, and behavioral problems. Sleep Med. 2000 Feb 1;1(1):21-32. doi: 10.1016/s1389-9457(99)00009-x.