Obstructive Sleep Apnea (OSA)NCT05479201
Prevalence of Obstructive Sleep Apnoea (OSA) Among 4-8 Years Old Children in the General Population
An observational study of Obstructive Sleep Apnea (OSA), run by Akureyri Hospital at 1 site in Iceland.
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. Read more about this study
- Who is it for?
- Ages 4 to 8 years
- Conditions the study is for
- Obstructive Sleep Apnea (OSA)
- What is being tested?
- Home based sleep test
- How many people
- 386 participants
- Where
- 1 siteIceland
- Study dates
- 5 Aug 2022to 30 Jun 2023
- Phase
- Observational
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 4 to 8 years
- All sexes
- Child
Study population: All children in a pre-specified geographical area 4-8 years of age
Who may be able to join
- Children 4-8-years old
Who cannot join
- Children with atrial fibrillation or ventricular trigemini
Trial locations and contacts
1 site in 1 country.
About this study
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.
Read the 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)
- Being tested
- Home based sleep test
- Medical subject headings
- Sleep Apnea, Obstructive
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Home based sleep testDiagnostic test
Also called SleepImage (FDA K182618)
Home based sleep test to calculate apnea hypopnea index (AHI) for evaluation of sleep apnea, sleep quality (SQI) and sleep duration (SD)
| Study group | Role | What they receive |
|---|---|---|
| Children 4-8 years of age | Not described Receives: Diagnostic Test: Home based sleep test |
What is being measured
The primary outcome is the main question the study is designed to answer.
Prevalence of OSA in 4-8 year old children
Apnea Hypopnea Index (AHI)
Measured: 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)
Apnea Hypopnea Index (AHI)
Measured: Baseline
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted29 Jul 2022
- Study start5 Aug 2022
- Primary completion15 Jun 2023
- Study completion30 Jun 2023
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for Obstructive Sleep Apnea (OSA)Studies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Cohort
- Time perspective
- Prospective
- Enrolment
- 386 participants (actual)
Sponsor and investigators
- Lead sponsor
- Akureyri Hospital
- Sponsor type
- Other government
- Collaborators
- MyCardio
- Responsible party
- Sponsor
- Investigators
- Hannes Pedersen, MD, Principal investigator, University of Iceland
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05479201
- Sponsor's protocol ID
- VSN-22-096
- Status last verified
- Jul 2022
- First submitted
- 25 Jul 2022
- Last updated
- 13 Jul 2023
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Publications
Magnusdottir S, Ingolfsdottir I, Hilmisson H, Hrolfsdottir L, Birkisson M, Hallgrimsdottir E, Johannesdottir G, Petersen H. Exploring nightly variability in sleep apnea and changes in severity classification with multi night sleep testing in a population based cohort of young children. Front Sleep. 2026 Aug 19;5:1903809. doi: 10.3389/frsle.2026.1903809. eCollection 2026.
PubMed 42687936
Study at a glance
From the registry record, last updated by the sponsor on 13 Jul 2023. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Prevalence of Obstructive Sleep Apnoea (OSA) Among 4-8 Years Old Children in the General Population
- ClinicalTrials.gov ID
- NCT05479201
- Acronym / sponsor ID
- VSN-22-096
- Conditions
- Obstructive Sleep Apnea (OSA)
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 386 participants (actual)
- Lead sponsor
- Akureyri HospitalOther government
- Collaborators
- MyCardio
- Study start
- 5 Aug 2022 (actual)
- Primary completion
- 15 Jun 2023 (actual)
- Study completion
- 30 Jun 2023 (actual)
- First posted
- 29 Jul 2022 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Children 4-8 years of age | – | Diagnostic Test: Home based sleep test |
Who may qualify
- Ages
- 4 to 8 years
- Sex
- All
- Age groups
- Child
- Study population
- All children in a pre-specified geographical area 4-8 years of age
Key inclusion criteria (1 listed)
- Children 4-8-years old
Key exclusion criteria (1 listed)
- Children with atrial fibrillation or ventricular trigemini
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Home based sleep testAlso: SleepImage (FDA K182618)Home based sleep test to calculate apnea hypopnea index (AHI) for evaluation of sleep apnea, sleep quality (SQI) and sleep duration (SD) | Diagnostic test | Children 4-8 years of age |
Primary outcome
Prevalence of OSA in 4-8 year old children
Time frame: Baseline
Apnea Hypopnea Index (AHI)
1 secondary outcome
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
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 13 Jul 2023.
- Derived from this study: PubMed 42687936Magnusdottir S, Ingolfsdottir I, Hilmisson H, Hrolfsdottir L, Birkisson M, Hallgrimsdottir E, Johannesdottir G, Petersen H. Exploring nightly variability in sleep apnea and changes in severity classification with multi night sleep testing in a population based cohort of young children. Front Sleep. 2026 Aug 19;5:1903809. doi: 10.3389/frsle.2026.1903809. eCollection 2026.
- Individual participant dataSharing planned: No
Related trials for Obstructive Sleep Apnea (OSA)
RecruitingObservational study
Development and Validation of a Multimodal Deep Learning Model Using Peripheral Oxygen Saturation and Ballistocardiography Signals for Predicting Apnea-Hypopnea Index in Obstructive Sleep Apnea
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A Study to Learn About the Monthly Dosing Study Medicine Called Berobenatide in Adults With Breathing Problems During Sleep and Overweight or Obesity Who Do Not Use a Breathing Machine (PAP) (VESPER-OSA 2)
Apnea, Sleep Disorders
Not yet recruitingPhase 2
Supplemental Oxygen for Sleep-Disordered Breathing in Adults With Chronic Opioid Use.
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Recruiting
Nightly Wearable Monitoring During Home-Based Submental Electrical Stimulation for Obstructive Sleep Apnea
Obstructive Sleep Apnea
RecruitingPhase 1/2
DRonabinol Treatment of OSA
Obstructive Sleep Apnea
Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Hannes Pedersen, MD principal investigator
University of Iceland
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Obstructive Sleep Apnea (OSA), run by Akureyri Hospital at 1 site in Iceland.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 1 inclusion and 1 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 13 Jul 2023. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Iceland. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Prevalence of OSA in 4-8 year old children (time frame: Baseline). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT05479201, which also lists 1 linked publication.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 13 Jul 2023.