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

July 11, 2023 updated by: Akureyri Hospital

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.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

Detailed 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.

Study Type

Observational

Enrollment (Actual)

386

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • Iceland
      • Akureyri, Iceland, 600
        • Sjukrahusid a Akureyri

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

4 years to 8 years (Child)

Accepts Healthy Volunteers

N/A

Sampling Method

Non-Probability Sample

Study Population

All children in a pre-specified geographical area 4-8 years of age

Description

Inclusion Criteria:

  • Children 4-8-years old

Exclusion Criteria:

  • Children with atrial fibrillation or ventricular trigemini

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Observational Models: Cohort
  • Time Perspectives: Prospective

Cohorts and Interventions

Group / Cohort
Intervention / Treatment
Children 4-8 years of age
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)
Other Names:
  • SleepImage (FDA K182618)

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Prevalence of OSA in 4-8 year old children
Time Frame: Baseline
Apnea Hypopnea Index (AHI)
Baseline

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
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)
Baseline

Other Outcome Measures

Outcome Measure
Measure Description
Time Frame
Intra-night variability in OSA
Time Frame: Baseline
Apnea Hypopnea Index (AHI)
Baseline

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Akureyri Hospital

Collaborators

MyCardio

Investigators

  • Principal Investigator: Hannes Pedersen, MD, University of Iceland

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

August 5, 2022

Primary Completion (Actual)

June 15, 2023

Study Completion (Actual)

June 30, 2023

Study Registration Dates

First Submitted

July 25, 2022

First Submitted That Met QC Criteria

July 26, 2022

First Posted (Actual)

July 29, 2022

Study Record Updates

Last Update Posted (Actual)

July 13, 2023

Last Update Submitted That Met QC Criteria

July 11, 2023

Last Verified

July 1, 2022

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID Numbers

  • VSN-22-096

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

NO

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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