NCT06141707

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

Trial Health

35
At Risk

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Trial has exceeded expected completion date
Enrollment
152

participants targeted

Target at P50-P75 for all trials

Timeline
Completed

Started Jan 2025

Shorter than P25 for all trials

Status
not yet recruiting

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

November 15, 2023

Completed
6 days until next milestone

First Posted

Study publicly available on registry

November 21, 2023

Completed
1.1 years until next milestone

Study Start

First participant enrolled

January 1, 2025

Completed
Same day until next milestone

Primary Completion

Last participant's last visit for primary outcome

January 1, 2025

Completed
1 month until next milestone

Study Completion

Last participant's last visit for all outcomes

February 1, 2025

Completed
Last Updated

December 10, 2024

Status Verified

December 1, 2024

Enrollment Period

Same day

First QC Date

November 15, 2023

Last Update Submit

December 5, 2024

Conditions

Keywords

obstructive sleep apnea, pediatric sleep questionnaire

Outcome Measures

Primary Outcomes (1)

  • total score

    total score in degree

    baseline

Study Arms (3)

OSA group

This group will include 66 parents in charge of participants with SRBDs.

Other: Arabic pediatric sleep questionnaire

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.

Other: Arabic pediatric sleep questionnaire

control group

control group will include 66 children with no OSA

Other: Arabic pediatric sleep questionnaire

Interventions

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.

OSA groupcontrol groupreliability group

Eligibility Criteria

Age2 Years - 18 Years
Sexall
Healthy VolunteersYes
Age GroupsChild (0-17), Adult (18-64)
Sampling MethodNon-Probability Sample
Study Population

children diagnosed as obstructive sleep apnea

You may qualify if:

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

You may not qualify if:

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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Related Publications (1)

  • 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.

MeSH Terms

Conditions

Sleep Apnea, Obstructive

Condition Hierarchy (Ancestors)

Sleep Apnea SyndromesApneaRespiration DisordersRespiratory Tract DiseasesSleep Disorders, IntrinsicDyssomniasSleep Wake DisordersNervous System Diseases

Study Officials

  • Fatma W Shahin, MD

    Minia University

    STUDY DIRECTOR

Central Study Contacts

Wafaa H Abdelhakeem, MD

CONTACT

Study Design

Study Type
observational
Observational Model
OTHER
Time Perspective
PROSPECTIVE
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Principal Investigator

Study Record Dates

First Submitted

November 15, 2023

First Posted

November 21, 2023

Study Start

January 1, 2025

Primary Completion

January 1, 2025

Study Completion

February 1, 2025

Last Updated

December 10, 2024

Record last verified: 2024-12