Factors Correlated With Obstructive Sleep Apnea in Children and Adolescents

March 14, 2023 updated by: Noéli Boscato, PhD, Federal University of Pelotas

Factors Correlated With Obstructive Sleep Apnea in Children and Adolescents Diagnosed by Polysomnography: Cross-sectional Study

Obstructive Sleep Apnea (OSA) is a severe condition of sleep respiratory disorders. It is characterized by partial (hypopnea) or total (apnea) obstruction of the upper airways, negatively affecting the general and oral health of children and adolescents. The Dentistry plays a fundamental role in OSA diagnosis and early intervention, minimizing health damage and progression of the disease into adulthood. Current scientific evidence related to OSA and associated factors, as well as the prevalence and severity of the disease in children and adolescents is still scarce and presents divergences in these age groups. A retrospective cross-sectional study will be conducted to investigate the prevalence, severity and correlation between sociodemographic, behavioral, clinical and sleep quality related factors and OSA in children and adolescents diagnosed by polysomnography (PSG), using the criteria recommended by the American Academy of Sleep Medicine (AASM). The sample will consist of individuals who answered the questionnaires, performed the PSG at the Pelotas Sleep Institute and met the study inclusion criteria.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

Detailed Description

Obstructive Sleep Apnea (OSA) is a severe condition among sleep respiratory disorders, characterized by intermittent episodes of partial (hypopnea) or total (apnea) obstruction of the upper airways during sleep. These obstructive episodes result in hypoxemia and hypercapnia, changes in intrathoracic pressure and sleep arousals, consequently leading sleep fragmentation and a non-restorative sleep pattern.

OSA affects 1 to 4% of the world's pediatric population, with a higher incidence between 2 to 8 years old, negatively affecting the general and oral health of children and adolescents. Studies show divergences regarding the prevalence among sexes, either showing similar rates for girls and boys, or a predilection of the disease for the male sex. Although scientific evidence reports known OSAs risk factors like adenotonsilar hypertrophy and obesity, there is still divergence of which associated characteristics are present in children and adolescents.

Diagnostic criteria of OSA in this population follows the recommendations of American Academy of Sleep Medicine (AASM) through the International Classification of Sleep Disorders (ICSD-3), which determines full-night PSG as the gold standard test for the diagnosis and severity of OSA, as it promotes a quantitative and objective assessment of disturbances in breathing and sleep patterns. Although parents' report of child behavior and symptoms is essential for establishing the diagnosis of OSA, the factors evaluated in the anamnesis and clinical examination, in general, do not present adequate accuracy for the diagnosis of OSA. The use of clinical history and physical examination alone is not suitable for a definite diagnose of OSA when compared to PSG. Besides, most questionnaires used as alternative diagnostic methods do not meet the necessary criteria to be considered as acceptable tools in the identification of children and adolescents with OSA.

There is evidence in the literature regarding OSA's significant morbidity in children and adolescents, leading to cardiovascular, metabolic and neurocognitive complications, resulting in reduced quality of life. Also, OSA is associated with several craniofacial and dental changes, such as retrognathia, class II malocclusion, vertical face growth and sleep bruxism. It becomes clear the importance of the dentist in identifying factors associated with OSA in children and adolescents, this being the first step towards early and definitive diagnosis, followed by adequate treatment, to minimize the health damage in this population. Therefore, this study aims to study the risk factors correlated with OSA, the prevalence and severity of illness in children and adolescents, considering that the current scientific evidence is divergent.

A retrospective cross-sectional study will be conducted to investigate the prevalence, severity and associations between diagnosis by gold-standard PSG examination and the sociodemographic, clinical conditions, sleep quality and sleep structure of children and adolescents, following the recommended criteria by the AASM. Also, this study aims to evaluate the association of sleep bruxism (SB) and OSA. The sample will consist of participants, between 1 and 18 years, who were referred to Pelotas Sleep Institute, answered the questionnaires (self-reported or parent-reported) and performed PSG for diagnostic purposes.

Study Type

Observational

Enrollment (Actual)

187

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

  • Brazil
    • RS
      • Pelotas, RS, Brazil, 96015-560
        • Federal University of Pelotas

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

1 year to 18 years (Child, Adult)

Accepts Healthy Volunteers

N/A

Genders Eligible for Study

All

Sampling Method

Non-Probability Sample

Study Population

Participants in the child and adolescent age group, referred to the Pelotas Sleep Institute for polysomnography in the period from January 2012 to December 2017.

Description

Inclusion Criteria:

  • Children (1 to 11 years) and adolescents (12 to 18 years), who were referred to a sleep laboratory
  • Participants who performed polysomnography and answered questionnaires (self-reported or parent-reported) at Pelotas Sleep Institute.

Exclusion Criteria:

  • Participants who present a history of syndromes, neuromuscular or neurological disorders;
  • Participants whose questionnaires were not completed.

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: Case-Only
  • Time Perspectives: Cross-Sectional

Cohorts and Interventions

Group / Cohort
Intervention / Treatment
Children and adolescents submitted to PSG in sleep laboratory
Children (1 to 11 years) and adolescents (12 to 18 years), who were referred to a sleep laboratory and submitted to full-night polysomnography due to suspicious of sleep disorders.
Diagnostic test: Polysomnography
Polysomnography, referred to as type I, allows assessing several sleep physiologic parameters (eg, EEG, electrooculogram, electromyogram, electrocardiogram, airflow, respiratory effort, oxygen saturation), whereas audio-video recording enables to document tooth-grinding sounds and distinguishing between rhythmic masticatory muscle activity (RMMA) and orofacial and other muscular activity during sleep. The apnea and hypopnea index (AHI) is defined as the number of obstructive apneas and hypopneas per hour of sleep. Obstructive Sleep Apnea is defined in PSG when AHI≥1 and is divided into the following categories, according to severity: mild OSA (AHI 1-4.9), moderate OSA (AHI 5-9.9) and severe OSA (IAH≥10). Based on the RMMA index (number of episodes per hour of sleep), sleep bruxism is diagnosed when episodes are greater than or equal to 2 (low-frequency SB, mild bruxism) or episodes are greater than or equal to 4 (high frequency SB, severe bruxism).

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Prevalence and severity of Obstructive Sleep Apnea (OSA) in children and adolescents evaluated by polysomnography
Time Frame: day 1
Children and adolescents will be evaluated to investigate the prevalence and severity of OSA, according to the criteria of de American Association of Sleep Medicine. Participants will be diagnosed with OSA if they present: a) self-report or parent-report of snoring or difficulty breathing during sleep; and b) one or more obstructive apneas per hour of sleep in polysomnography. The apnea-hypopnea index (AHI) was calculated as the average number of apnea-hypopnea episodes per hour of sleep. Individuals with an AHI ≥ 1 were diagnosed with OSA via PSG, and its severity was classified as mild (AHI ≥ 1 and < 5 events/h), moderate (AHI ≥ 5 and < 10 events/h), and severe OSA (AHI ≥ 10 events/h).
day 1

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Sociodemographic and clinical condition variables
Time Frame: day 1

The following sociodemographic data will be evaluated:

1.1 Age: participants between (1 to 11 years) will be classified as children and participants between (12 to 18 years) will be classified as adolescents; 1.2 Sex: participants will be classified as (male or female); 1.3 Parental education: participants will be classified according to their parental education (< 8 years or ≥ 8 years); 1.4 Family structure: participants will be classified according to their family structure as (nuclear or non-nuclear).

The following clinical condition data will be evaluated:

1.5 Body mass index (BMI). Weight and height will be combined to report BMI in kg/m^2): children and adolescents will be classified as obese/ overweight/underweight/ (≥ 95th percentile/ 85th to < 95th percentile/< 5th percentile, respectively) or normal weight (5th to < 85th percentile), according to World Health Organization Child Growth Standards.
day 1
Sleep quality variables
Time Frame: day 1

Sleep Quality will be evaluated with the following questions:

  1. Bedtime: how many hours does your child sleep (<8 hours or ≥8 hours); how long does it take to sleep (up to 15min, or >15 min); child resists going to bed at bedtime (no or yes); child feels anxiety or fear at bedtime (no or yes);
  2. Sleep behavior: child wakes up more than twice during the night (no or yes); child is restless and moves a lot during sleep (no or yes); child has suffocation or difficulty breathing during the night (no or yes); child sweats a lot during the night (no or yes); child grit his/her teeth while sleeping (no or yes); child has nightmares (no or yes); child snores during the night (no or yes) child has sleep enuresis (no or yes);
  3. Morning wake up: child has difficulty waking up (no or yes); child feels tired after waking up (no or yes); child is sleepy during the day (no or yes); child has headache in the morning (no or yes); child has mouth breathing during the day (no or yes).
day 1
Sleep structure variables
Time Frame: day 1
Sleep structure was evaluated with the following polysomnography data: sleep onset latency in minutes, rapid eye movement (REM) sleep latency in minutes, wake up after sleep onset (WASO) in minutes, total sleep time in minutes, sleep efficiency (good >85% or bad <84.9%), non-rapid eye movement (NREM) sleep time in stages N1 (%), N2 (%), and N3 (%), rapid eye movement (REM) sleep time (%), arousal, respiratory disturbance index (RDI), index of apnea and hypopnea (IAH).
day 1
Sleep Bruxism detection
Time Frame: day 1
Children and adolescents will be diagnosed with SB, according the criteria of de American Association of Sleep Medicine, if they present: a) regular or frequent tooth grinding sounds occurring during sleep; and b) transient morning jaw muscle pain or fatigue; and/or temporal headache (AASM, 2014).
day 1

Collaborators and Investigators

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

Sponsor

Federal University of Pelotas

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

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)

April 1, 2020

Primary Completion (Actual)

July 1, 2020

Study Completion (Actual)

March 15, 2021

Study Registration Dates

First Submitted

March 28, 2020

First Submitted That Met QC Criteria

March 28, 2020

First Posted (Actual)

March 31, 2020

Study Record Updates

Last Update Posted (Actual)

March 16, 2023

Last Update Submitted That Met QC Criteria

March 14, 2023

Last Verified

March 1, 2023

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • FUPelotas6

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

UNDECIDED

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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