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NCT Number: NCT06367400

Validation of Pediatric Sleep Questionnaire on a Swedish Cohort

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.

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Key information

Conditions

Obstructive Sleep Apnea Apnea Dyssomnias Mental Disorders Nervous System Diseases Neurologic Manifestations Obstructive Sleep Apnea of Child Pathological Conditions, Signs and Symptoms Respiration Disorders Respiratory Tract Diseases Signs and Symptoms Sleep Apnea Syndromes Sleep Apnea, Obstructive Sleep Disorder Sleep Disorders in Children Sleep Disorders, Intrinsic Sleep Wake Disorders

Age range

18 month–15 year

Sex eligibility

All sexes

Study type

Observational

Primary location

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Pediatric Sleep Questionnaire

Diagnostic Test

Questionnaire with 22 questions of symptoms of OSDB

Primary outcomes

  1. 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.

  2. 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

  1. 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.

  2. PSQ vs. PSG

    Time frame: 6 months

    PSQ-levels compared to Polysomnography outcomes

  3. 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

Other outcomes

  1. 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

Study contacts

Contact information is provided by the study sponsor or research team.

Isabella Sjölander

CONTACT

[email protected]

018-6110000

Sponsors and collaborators

Lead sponsor

Uppsala University

Other

Collaborators

  • Göteborg University
  • Karolinska Institutet
  • Umeå University
  • Örebro University, Sweden

Registry information

Official study title

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

Important dates

Study start
2024
Primary completion
2024
Study completion
2034
First posted
Apr 16, 2024
Registry last updated
Apr 16, 2024

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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