Factors Correlated With Obstructive Sleep Apnea in Children and Adolescents

NCT04328402 | Completed DMC

• 1 other identifier: FUPelotas6
• Study Type: observational
• Target: 187
• Locations: 1 country
• Sites: 1

Brief Summary

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.

Conditions

Obstructive Sleep Apnea of Child

Keywords

diagnostic; polysomnography; sleep architecture; obstructive sleep apnea

Outcome Measures

Primary Outcomes (1)

• Prevalence and severity of Obstructive Sleep Apnea (OSA) in children and adolescents evaluated by polysomnography

  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 Outcomes (4)

• Sociodemographic and clinical condition variables

  day 1

• Sleep quality variables

  day 1

• Sleep structure variables

  day 1

• Sleep Bruxism detection

  day 1

Study Arms (1)

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

Interventions

Polysomnography DIAGNOSTIC_TEST

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).

Children and adolescents submitted to PSG in sleep laboratory

Eligibility Criteria

• Age: 1 Year - 18 Years
• Sex: all
• Age Groups: Child (0-17), Adult (18-64)
• 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.

You may qualify if:

• 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.

You may not qualify if:

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

Sponsors & Collaborators

• Federal University of Pelotas: lead

Study Sites (1)

Federal University of Pelotas

Pelotas, Rio Grande do Sul, 96015-560, Brazil

Location

Related Publications (15)

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  PMID: 29068938 BACKGROUND

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  PMID: 24109201 BACKGROUND

• Baidas L, Al-Jobair A, Al-Kawari H, AlShehri A, Al-Madani S, Al-Balbeesi H. Prevalence of sleep-disordered breathing and associations with orofacial symptoms among Saudi primary school children. BMC Oral Health. 2019 Mar 12;19(1):43. doi: 10.1186/s12903-019-0735-3.

  PMID: 30866906 BACKGROUND

• Andersen IG, Holm JC, Homoe P. Obstructive sleep apnea in children and adolescents with and without obesity. Eur Arch Otorhinolaryngol. 2019 Mar;276(3):871-878. doi: 10.1007/s00405-019-05290-2. Epub 2019 Jan 28.

  PMID: 30689039 BACKGROUND

• Baker M, Scott B, Johnson RF, Mitchell RB. Predictors of Obstructive Sleep Apnea Severity in Adolescents. JAMA Otolaryngol Head Neck Surg. 2017 May 1;143(5):494-499. doi: 10.1001/jamaoto.2016.4130.

  PMID: 28241176 BACKGROUND

• Chen T, Hughes ME, Wang H, Wang G, Hong X, Liu L, Ji Y, Pearson C, Li S, Hao L, Wang X. Prenatal, Perinatal, and Early Childhood Factors Associated with Childhood Obstructive Sleep Apnea. J Pediatr. 2019 Sep;212:20-27.e10. doi: 10.1016/j.jpeds.2019.05.053. Epub 2019 Jun 26.

  PMID: 31253409 BACKGROUND

• Sanchez T, Rojas C, Casals M, Bennett JT, Galvez C, Betancur C, Mesa JT, Brockmann PE. [Prevalence and risk factors for sleep-disordered breathing in chilean schoolchildren]. Rev Chil Pediatr. 2018 Dec;89(6):718-725. doi: 10.4067/S0370-41062018005000902. Spanish.

  PMID: 30725060 BACKGROUND

• Krzeski A, Burghard M. Obstructive sleep disordered breathing in children - an important problem in the light of current European guidelines. Otolaryngol Pol. 2018 Jun 29;72(5):9-16. doi: 10.5604/01.3001.0012.1570.

  PMID: 30460910 BACKGROUND

• Goyal M, Johnson J. Obstructive Sleep Apnea Diagnosis and Management. Mo Med. 2017 Mar-Apr;114(2):120-124.

  PMID: 30228558 BACKGROUND

• Certal V, Catumbela E, Winck JC, Azevedo I, Teixeira-Pinto A, Costa-Pereira A. Clinical assessment of pediatric obstructive sleep apnea: a systematic review and meta-analysis. Laryngoscope. 2012 Sep;122(9):2105-14. doi: 10.1002/lary.23465. Epub 2012 Aug 9.

  PMID: 22886768 BACKGROUND

• Brietzke SE, Katz ES, Roberson DW. Can history and physical examination reliably diagnose pediatric obstructive sleep apnea/hypopnea syndrome? A systematic review of the literature. Otolaryngol Head Neck Surg. 2004 Dec;131(6):827-32. doi: 10.1016/j.otohns.2004.07.002.

  PMID: 15577775 BACKGROUND

• Abrishami A, Khajehdehi A, Chung F. A systematic review of screening questionnaires for obstructive sleep apnea. Can J Anaesth. 2010 May;57(5):423-38. doi: 10.1007/s12630-010-9280-x. Epub 2010 Feb 9.

  PMID: 20143278 BACKGROUND

• De Luca Canto G, Singh V, Major MP, Witmans M, El-Hakim H, Major PW, Flores-Mir C. Diagnostic capability of questionnaires and clinical examinations to assess sleep-disordered breathing in children: a systematic review and meta-analysis. J Am Dent Assoc. 2014 Feb;145(2):165-78. doi: 10.14219/jada.2013.26.

  PMID: 24487608 BACKGROUND

• Pabla L, Duffin J, Flood L, Blackmore K. Paediatric obstructive sleep apnoea: can our identification of surgical candidates be evidence-based? J Laryngol Otol. 2018 Apr;132(4):284-292. doi: 10.1017/S0022215118000208. Epub 2018 Feb 14.

  PMID: 29439747 BACKGROUND

MeSH Terms

Conditions

Disease; Sleep Apnea, Obstructive

Interventions

Polysomnography

Condition Hierarchy (Ancestors)

Pathologic Processes; Pathological Conditions, Signs and Symptoms; Sleep Apnea Syndromes; Apnea; Respiration Disorders; Respiratory Tract Diseases; Sleep Disorders, Intrinsic; Dyssomnias; Sleep Wake Disorders; Nervous System Diseases

Intervention Hierarchy (Ancestors)

Monitoring, Physiologic; Diagnostic Techniques and Procedures; Diagnosis

Study Officials

• Noéli Boscato, PhD

  Federal University of Pelotas

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: observational
• Observational Model: CASE ONLY
• Time Perspective: CROSS SECTIONAL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: PhD, Associate Professor, School of Dentistry

Study Record Dates

• First Submitted: March 28, 2020
• First Posted: March 31, 2020
• Study Start: April 1, 2020
• Primary Completion: July 1, 2020
• Study Completion: March 15, 2021
• Last Updated: March 16, 2023

Record last verified: 2023-03

Locations

BR (1)