Validation of Pediatric Sleep Questionnaire on a Swedish Cohort

April 11, 2024 updated by: Uppsala University

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

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.

Study Overview

Status

Recruiting

Conditions

Intervention / Treatment

Study Type

Observational

Enrollment (Estimated)

520

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Contact

Study Locations

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

  • Child

Accepts Healthy Volunteers

No

Sampling Method

Non-Probability Sample

Study Population

The study population will be included from the ENT-clinics or the waiting lists to surgical treatments.

Description

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 Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

Cohorts and Interventions

Group / Cohort
Intervention / Treatment
PSQ-cohort
Patients recruited from Akademiska Sjukhuset, Örebro, Västra Götaland, Skåne, Stockholm and Umeå.
Diagnostic test: Pediatric Sleep Questionnaire
Questionnaire with 22 questions of symptoms of OSDB

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
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.
Baseline
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
6 months to 12 months

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
PSQ vs OSA-18
Time Frame: 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.
6 months
PSQ vs. PSG
Time Frame: 6 months
PSQ-levels compared to Polysomnography outcomes
6 months
PSQ levels of healthy controls vs children with OSDB
Time Frame: 6 months
Compare the PSQ-levels of children with OSDB-symptoms to children without OSDB-symptoms
6 months

Other Outcome Measures

Outcome Measure
Measure Description
Time Frame
5 and 10 years follow-up
Time Frame: 11 years
PSQ and OSA-18 compared to baseline and after 6months compared to levels at 5 and 10 years follow-up
11 years

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Uppsala University

Collaborators

Karolinska Institutet
Göteborg University
Umeå University
Örebro University, Sweden

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

March 1, 2024

Primary Completion (Estimated)

December 31, 2024

Study Completion (Estimated)

December 31, 2034

Study Registration Dates

First Submitted

April 3, 2024

First Submitted That Met QC Criteria

April 11, 2024

First Posted (Actual)

April 16, 2024

Study Record Updates

Last Update Posted (Actual)

April 16, 2024

Last Update Submitted That Met QC Criteria

April 11, 2024

Last Verified

April 1, 2024

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • SwePSQ

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

NO

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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