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Validation of Pediatric Sleep Questionnaire on a Swedish Cohort

Validation of Pediatric Sleep Questionnaire, a Multi-center Study in Sweden

Status
Recruiting
Phases
Unknown
Study type
Observational
Source
ClinicalTrials.gov
Registry ID
NCT06367400
Enrollment
520
Registered
2024-04-16
Start date
2024-03-01
Completion date
2034-12-31
Last updated
2024-04-16

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Obstructive Sleep Apnea, Obstructive Sleep Apnea of Child, Sleep Disorder, Sleep Disorders in Children

Keywords

OSDB, PSQ, Pediatrics

Brief summary

This study is aimed to validate the questionnaire called Pediatric Sleep Questionnaire on a Swedish cohort of children from 18 months to 15 years old with obstructive sleep disordered breathing.

Interventions

DIAGNOSTIC_TESTPediatric Sleep Questionnaire

Questionnaire with 22 questions of symptoms of OSDB

Sponsors

Karolinska Institutet
CollaboratorOTHER
Örebro University, Sweden
CollaboratorOTHER
Umeå University
CollaboratorOTHER
Göteborg University
CollaboratorOTHER
Uppsala University
Lead SponsorOTHER

Study design

Observational model
COHORT
Time perspective
PROSPECTIVE

Eligibility

Sex/Gender
ALL
Age
18 Months to 15 Years
Healthy volunteers
No

Inclusion criteria

* Children with OSDB-symptoms referred to ENT-clinics * Age between 18 months and 15 years old. * Good knowledge of the Swedish language

Exclusion criteria

* Craniofacial abnormalities * Mb Down * neuromuscular disorders * do not understand swedish

Design outcomes

Primary

MeasureTime frameDescription
Level of baseline PSQBaselineLevel of baseline PSQ of children who are referred to surgery. A level of \>33% yes i.e. 8/22 indicates medium to severe OSA and less than five yes indicates a healthy status. Minimum is 0 yes and maximum is 22 where 22 is the most severe disease. PSQ has a score from 0 to 22 where every yes on the scale is one point. A level of 8 yes (\>33%) indicates moderate to severe OSDB and less than five indicates no OSDB.
Changes of baseline PSQ after treatment6 months to 12 monthsChanges of baseline PSQ with 6 months follow-up, after treatment/surgery

Secondary

MeasureTime frameDescription
PSQ vs OSA-186 monthsCompare PSQ-levels with OSA-18 levels OSA-18 is accounted as a scale from 18 to 126 points where a higher rate is a more severe disease. Score less than 60 suggests a mild impact on quality of life. Scores between 60 and 80 a moderate impact and a score higher than 80 severe impact. OSA-18 has a summary of 18 - 126 points where a higher level indicates worse quality of life. A score less than 60 indicates a mild impact on quality of life and score between 60 and 80 indicates moderate impact whereas a score above 80 indicates a high impact.
PSQ vs. PSG6 monthsPSQ-levels compared to Polysomnography outcomes
PSQ levels of healthy controls vs children with OSDB6 monthsCompare the PSQ-levels of children with OSDB-symptoms to children without OSDB-symptoms

Other

MeasureTime frameDescription
5 and 10 years follow-up11 yearsPSQ and OSA-18 compared to baseline and after 6months compared to levels at 5 and 10 years follow-up

Countries

Sweden

Contacts

Primary ContactIsabella Sjölander
isabella.sjolander@uu.se018-6110000

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026