Validation of Pediatric Sleep Questionnaire on a Swedish Cohort

Recruiting

• Conditions: Sleep Disorder; Obstructive Sleep Apnea; Sleep Disorders in Children; Obstructive Sleep Apnea of Child
• Interventions: Diagnostic Test: Pediatric Sleep Questionnaire

• Registration Number: NCT06367400
• Lead Sponsor: Uppsala University

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.

Detailed Description

Not available

Study Timeline

• Study Start: 2024-03-01
• Status Verified: 2024-04
• Study First Submitted: 2024-04-03
• Study First Submitted QC: 2024-04-11
• Last Update Submitted: 2024-04-11
• Study First Posted: 2024-04-16
• Last Update Posted: 2024-04-16
• Primary Completion: 2024-12-31
• Study Completion: 2034-12-31

Recruitment & Eligibility

• Status: RECRUITING
• Sex: All
• Target Recruitment: 520

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

Study & Design

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Arm && Interventions

Group	Intervention	Description
PSQ-cohort	Pediatric Sleep Questionnaire	Patients recruited from Akademiska Sjukhuset, Örebro, Västra Götaland, Skåne, Stockholm and Umeå.

Primary Outcome Measures

Name	Time	Method
Level of baseline PSQ	Baseline	Level 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 treatment	6 months to 12 months	Changes of baseline PSQ with 6 months follow-up, after treatment/surgery

Secondary Outcome Measures

Name	Time	Method
PSQ levels of healthy controls vs children with OSDB	6 months	Compare the PSQ-levels of children with OSDB-symptoms to children without OSDB-symptoms
PSQ vs OSA-18	6 months	Compare 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. PSG	6 months	PSQ-levels compared to Polysomnography outcomes

Trial Locations

Locations (1)

Akademiska hospital; 🇸🇪 Uppsala, Sweden