Validation of Pediatric Sleep Questionnaire on a Swedish Cohort

Trial statusRecruiting
Trial phaseNot listed
Trial typeObservational
Biological sexAll
Age18-15
SponsorUppsala University

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 volunteers

Qualifiers

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

Design model

Cohort

Time perspective

Prospective

Treatments tested in this trial

  • Pediatric Sleep Questionnaire

    Diagnostic test

    Questionnaire with 22 questions of symptoms of OSDB

Treatment groups

520 Participants
are divided into 1 treatment group
Group A: PSQ-cohort1 intervention

Trial outcomes

Primary outcomes

1

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.

Time frame
Baseline
2

Changes of baseline PSQ after treatment

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

Time frame
6 months to 12 months

Secondary outcomes

1

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.

Time frame
6 months
2

PSQ vs. PSG

PSQ-levels compared to Polysomnography outcomes

Time frame
6 months
3

PSQ levels of healthy controls vs children with OSDB

Compare the PSQ-levels of children with OSDB-symptoms to children without OSDB-symptoms

Time frame
6 months

Other outcomes

1

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

Time frame
11 years

Sponsors and contacts

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Uppsala University

Lead sponsor

Karolinska Institutet

Collaborator

Örebro University, Sweden

Collaborator

Umeå University

Collaborator

Göteborg University

Collaborator