About this trial
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.
Eligibility criteria
This trial does not accept healthy volunteersQualifiers
Children with OSDB-symptoms referred to ENT-clinics
Age between 18 months and 15 years old.
Good knowledge of the Swedish language
Disqualifiers
Craniofacial abnormalities
Mb Down
neuromuscular disorders
do not understand swedish
Trial population
The study population will be included from the ENT-clinics or the waiting lists to surgical treatments.
Trial design
Cohort
Prospective
Treatments tested in this trial
Pediatric Sleep Questionnaire
Diagnostic testQuestionnaire with 22 questions of symptoms of OSDB
Treatment groups
Trial outcomes
Primary outcomes
Level of baseline PSQ
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
Changes of baseline PSQ with 6 months follow-up, after treatment/surgery
Secondary outcomes
PSQ vs OSA-18
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
PSQ-levels compared to Polysomnography outcomes
PSQ levels of healthy controls vs children with OSDB
Compare the PSQ-levels of children with OSDB-symptoms to children without OSDB-symptoms
Other outcomes
5 and 10 years follow-up
PSQ and OSA-18 compared to baseline and after 6months compared to levels at 5 and 10 years follow-up
Sponsors and contacts
Click on the lead sponsor to view all of their trials.
Uppsala University
Lead sponsor
Karolinska Institutet
Collaborator
Örebro University, Sweden
Collaborator
Umeå University
Collaborator
Göteborg University
Collaborator