Validation of Pediatric Sleep Questionnaire on a Swedish Cohort

Obstructive Sleep Apnea Clinical Trial

Official title:

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

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT06367400
• Other study ID #: SwePSQ
• Status: Recruiting
• Start date: March 1, 2024
• Est. completion date: December 31, 2034

Study information

• Verified date: April 2024
• Source: Uppsala University
• Contact: Isabella Sjölander
• Phone: 018-6110000
• Email: isabella.sjolander[@]uu.se
• Is FDA regulated: No
• Study type: Observational

Clinical Trial 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.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 520
• Est. completion date: December 31, 2034
• Est. primary completion date: December 31, 2024
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Months to 15 Years

Eligibility

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

Related Conditions & MeSH terms

• Apnea
• Obstructive Sleep Apnea
• Obstructive Sleep Apnea of Child
• Parasomnias
• Sleep Apnea Syndromes
• Sleep Apnea, Obstructive
• Sleep Disorder
• Sleep Disorders in Children
• Sleep Wake Disorders

Intervention

Diagnostic Test:
• Pediatric Sleep Questionnaire
Questionnaire with 22 questions of symptoms of OSDB

Locations

Country	Name	City	State
Sweden	Akademiska hospital	Uppsala

Sponsors (5)

Lead Sponsor	Collaborator
Uppsala University	Göteborg University, Karolinska Institutet, Örebro University, Sweden, Umeå University

Country where clinical trial is conducted

Sweden, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Other	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	11 years
Primary	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
Primary	Changes of baseline PSQ after treatment	Changes of baseline PSQ with 6 months follow-up, after treatment/surgery	6 months to 12 months
Secondary	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.	6 months
Secondary	PSQ vs. PSG	PSQ-levels compared to Polysomnography outcomes	6 months
Secondary	PSQ levels of healthy controls vs children with OSDB	Compare the PSQ-levels of children with OSDB-symptoms to children without OSDB-symptoms	6 months