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

NCT ID: NCT05479201

Last Updated: 2023-07-13

Basic Information

• Recruitment Status: COMPLETED
• Total Enrollment: 386 participants
• Study Classification: OBSERVATIONAL
• Study Start Date: 2022-08-05
• Study Completion Date: 2023-06-30

Brief 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.

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.

Conditions

Obstructive Sleep Apnea (OSA)

Study Design

• Observational Model Type: COHORT
• Study Time Perspective: PROSPECTIVE

Study Groups

Children 4-8 years of age

Home based sleep test

Intervention Type: DIAGNOSTIC_TEST

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

Interventions

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)

Intervention Type: DIAGNOSTIC_TEST

Other Intervention Names

SleepImage (FDA K182618)

Eligibility Criteria

Inclusion Criteria

• Children 4-8-years old

Exclusion Criteria

• Children with atrial fibrillation or ventricular trigemini

• Minimum Eligible Age: 4 Years
• Maximum Eligible Age: 8 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

MyCardio

UNKNOWN

Sponsor Role: collaborator

Akureyri Hospital

OTHER_GOV

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Principal Investigators

Hannes Pedersen, MD

Role: PRINCIPAL_INVESTIGATOR

University of Iceland

Locations

Sjukrahusid a Akureyri

Akureyri, , Iceland

Countries

Iceland

Other Identifiers

VSN-22-096

Identifier Type: -

Identifier Source: org_study_id