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OpenTrials
Completed

NCT Number: NCT05479201

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

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.

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Key information

Age range

4 year–8 year

Sex eligibility

All sexes

Study type

Observational

Primary location

Sjukrahusid a Akureyri

Akureyri, 600, Iceland

About this study

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.

Who can participate

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

Inclusion criteria

  • Children 4-8-years old

Exclusion criteria

  • Children with atrial fibrillation or ventricular trigemini

Treatment and study plan

Home based sleep test

Diagnostic Test

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

Other names: SleepImage (FDA K182618)

Primary outcomes

  1. Prevalence of OSA in 4-8 year old children

    Time frame: Baseline

    Apnea Hypopnea Index (AHI)

Secondary outcomes

  1. 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)

    Time frame: Baseline

    Apnea Hypopnea Index (AHI)

Other outcomes

  1. Intra-night variability in OSA

    Time frame: Baseline

    Apnea Hypopnea Index (AHI)

Sponsors and collaborators

Lead sponsor

Akureyri Hospital

Other Gov

Collaborators

  • MyCardio

Registry information

Important dates

Study start
2022
Primary completion
2023
Study completion
2023
First posted
Jul 29, 2022
Registry last updated
Jul 13, 2023

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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