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Clinical Trial Details — Status: Completed

Administrative data

NCT number NCT05479201
Other study ID # VSN-22-096
Secondary ID
Status Completed
Phase
First received
Last updated
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
Health authority
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
Accepts healthy volunteers
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

Study Design


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
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