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

NCT05479201 | Completed

• 1 other identifier: VSN-22-096
• Study Type: observational
• Target: 386
• Locations: 1 country
• Sites: 1

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.

Conditions

Obstructive Sleep Apnea (OSA)

Outcome Measures

Primary Outcomes (1)

• Prevalence of OSA in 4-8 year old children

  Apnea Hypopnea Index (AHI)

  Baseline

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)

  Baseline

Other Outcomes (1)

• Intra-night variability in OSA

  Baseline

Study Arms (1)

Children 4-8 years of age

Diagnostic Test: Home based sleep test

Interventions

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)

Also known as: SleepImage (FDA K182618)

Children 4-8 years of age

Eligibility Criteria

• Age: 4 Years - 8 Years
• Sex: all
• Age Groups: Child (0-17)
• Sampling Method: Non-Probability Sample

Study Population

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

You may qualify if:

• Children 4-8-years old

You may not qualify if:

• Children with atrial fibrillation or ventricular trigemini

Sponsors & Collaborators

• Akureyri Hospital: lead
• MyCardio: collaborator

Study Sites (1)

Sjukrahusid a Akureyri

Akureyri, 600, Iceland

Location

MeSH Terms

Conditions

Sleep Apnea, Obstructive

Condition Hierarchy (Ancestors)

Sleep Apnea Syndromes; Apnea; Respiration Disorders; Respiratory Tract Diseases; Sleep Disorders, Intrinsic; Dyssomnias; Sleep Wake Disorders; Nervous System Diseases

Study Officials

• Hannes Pedersen, MD

  University of Iceland

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: PROSPECTIVE
• Sponsor Type: OTHER GOV
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: July 25, 2022
• First Posted: July 29, 2022
• Study Start: August 5, 2022
• Primary Completion: June 15, 2023
• Study Completion: June 30, 2023
• Last Updated: July 13, 2023

Record last verified: 2022-07

Data Sharing

• IPD Sharing: Will not share

Locations

IC (1)