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Clinical Trials/NCT06367400
NCT06367400
Recruiting
Not Applicable

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

Uppsala University1 site in 1 country520 target enrollmentMarch 1, 2024

Overview

Phase
Not Applicable
Intervention
Not specified
Conditions
Obstructive Sleep Apnea
Sponsor
Uppsala University
Enrollment
520
Locations
1
Primary Endpoint
Level of baseline PSQ
Status
Recruiting
Last Updated
2 years ago

Overview

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.

Registry
clinicaltrials.gov
Start Date
March 1, 2024
End Date
December 31, 2034
Last Updated
2 years ago
Study Type
Observational
Sex
All

Investigators

Sponsor
Uppsala University
Responsible Party
Sponsor

Eligibility Criteria

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
  • neuromuscular disorders
  • do not understand swedish

Outcomes

Primary Outcomes

Level of baseline PSQ

Time Frame: 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

Time Frame: 6 months to 12 months

Changes of baseline PSQ with 6 months follow-up, after treatment/surgery

Secondary Outcomes

  • PSQ levels of healthy controls vs children with OSDB(6 months)
  • PSQ vs OSA-18(6 months)
  • PSQ vs. PSG(6 months)

Study Sites (1)

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