Prevalence of Obstructive Sleep Apnoea (OSA) Among 4-8 Years Old Children in the General Population

Obstructive Sleep Apnea (OSA) Clinical Trial

Official title:

Prevalence of Obstructive Sleep Apnoea (OSA) Among 4-8 Years Old Children in the General Population

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT05479201
• Other study ID #: VSN-22-096
• Status: Completed
• Start date: August 5, 2022
• Est. completion date: June 30, 2023

Study information

• Verified date: July 2022
• Source: Akureyri Hospital
• Contact: n/a
• Is FDA regulated: No
• Study type: Observational

Clinical Trial Summary

The purpose of this study is to estimated prevalence of obstructive sleep apnea (OSA) in 4-8 year old children. To date, most studies estimating prevalence of sleep apnea in young children are based on utilizing subjective questionnaires. The few studies that have utilized objective sleep measures have tested only those children suspected of sleep apnea based on subjective questionnaires, finding prevalence in the range of 1-13%. Untreated OSA is associated with significant morbidities in children, affecting their behavior, cognitive development, cardiovascular-and cardio metabolic health, endocrine and immune function. Better understanding of prevalence of sleep apnea in young children should be beneficial. This study will help to understand the prevalence of sleep apnea in each age-group of children 4-8 years of age and whether certain groups, such as children with obesity or asthma have higher prevalence and/or more severe disease.

The primary objective of this study is to get better understanding of prevalence and severity of sleep apnea in young children using objective sleep measures for all participants.

Description:

The study is a population-based, observational study of 4-8 year old children located in Akureyri, Iceland. All parents in this geographical area will be invited for their child/children to participate in the study.

Parents of all participating children will be asked to answer questionnaires to assess general health, sleep habits, behavior and quality of life and then measure their sleep for five consecutive nights with a home based sleep test.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 386
• Est. completion date: June 30, 2023
• Est. primary completion date: June 15, 2023
• Gender: All
• Age group: 4 Years to 8 Years

Eligibility

Inclusion Criteria:

• Children 4-8-years old

Exclusion Criteria:

• Children with atrial fibrillation or ventricular trigemini

Related Conditions & MeSH terms

• Apnea
• Obstructive Sleep Apnea (OSA)
• Sleep Apnea Syndromes
• Sleep Apnea, Obstructive

Intervention

Diagnostic Test:
• Home based sleep test
Home based sleep test to calculate apnea hypopnea index (AHI) for evaluation of sleep apnea, sleep quality (SQI) and sleep duration (SD)

Locations

Country	Name	City	State
Iceland	Sjukrahusid a Akureyri	Akureyri

Sponsors (2)

Lead Sponsor	Collaborator
Akureyri Hospital	MyCardio

Country where clinical trial is conducted

Iceland, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Other	Intra-night variability in OSA	Apnea Hypopnea Index (AHI)	Baseline
Primary	Prevalence of OSA in 4-8 year old children	Apnea Hypopnea Index (AHI)	Baseline
Secondary	Prevalence of OSA defined by a specific age range (4-5-year-old/5-6-year-old/6-7-year-old/7-8-year-old)	Apnea Hypopnea Index (AHI)	Baseline