Validation of Pediatric Sleep Questionnaire on a Swedish Cohort

NCT06367400 | Recruiting

• 1 other identifier: SwePSQ
• Study Type: observational
• Target: 520
• Locations: 1 country
• Sites: 1

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.

Conditions

Obstructive Sleep Apnea; Sleep Disorder; Sleep Disorders in Children; Obstructive Sleep Apnea of Child

Keywords

OSDB; PSQ; Pediatrics

Outcome Measures

Primary Outcomes (2)

• 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.

  Baseline

• Changes of baseline PSQ after treatment

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

  6 months to 12 months

Secondary Outcomes (3)

• PSQ vs OSA-18

  6 months

• PSQ vs. PSG

  6 months

• PSQ levels of healthy controls vs children with OSDB

  6 months

Other Outcomes (1)

• 5 and 10 years follow-up

  11 years

Study Arms (1)

PSQ-cohort

Patients recruited from Akademiska Sjukhuset, Örebro, Västra Götaland, Skåne, Stockholm and Umeå.

Diagnostic Test: Pediatric Sleep Questionnaire

Interventions

Pediatric Sleep Questionnaire DIAGNOSTIC_TEST

Questionnaire with 22 questions of symptoms of OSDB

PSQ-cohort

Eligibility Criteria

• Age: 18 Months - 15 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Child (0-17)
• Sampling Method: Non-Probability Sample

Study Population

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

You may qualify if:

• Children with OSDB-symptoms referred to ENT-clinics
• Age between 18 months and 15 years old.
• Good knowledge of the Swedish language

You may not qualify if:

• Craniofacial abnormalities
• Mb Down
• neuromuscular disorders
• do not understand swedish

Sponsors & Collaborators

• Uppsala University: lead
• Karolinska Institutet: collaborator
• Örebro University, Sweden: collaborator
• Umeå University: collaborator
• Göteborg University: collaborator

Study Sites (1)

Akademiska hospital

Uppsala, Sweden

RECRUITING

MeSH Terms

Conditions

Sleep Apnea, Obstructive; Sleep Wake Disorders

Condition Hierarchy (Ancestors)

Sleep Apnea Syndromes; Apnea; Respiration Disorders; Respiratory Tract Diseases; Sleep Disorders, Intrinsic; Dyssomnias; Nervous System Diseases; Neurologic Manifestations; Signs and Symptoms; Pathological Conditions, Signs and Symptoms; Mental Disorders

Central Study Contacts

Isabella Sjölander

CONTACT

018-6110000; isabella.sjolander@uu.se

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: PROSPECTIVE
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: April 3, 2024
• First Posted: April 16, 2024
• Study Start: March 1, 2024
• Primary Completion: December 31, 2024
• Study Completion (Estimated): December 31, 2034
• Last Updated: April 16, 2024

Record last verified: 2024-04

Data Sharing

• IPD Sharing: Will not share

Locations

SE (1)