Obstructive Sleep Apnea of ChildNCT04328402
Factors Correlated With Obstructive Sleep Apnea in Children and Adolescents
An observational study of Obstructive Sleep Apnea of Child, run by Federal University of Pelotas at 1 site in Brazil.
Trial 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. Read more about this study
- Who is it for?
- Ages 1 year to 18 years
- Conditions the study is for
- Obstructive Sleep Apnea of Child
- What is being tested?
- Polysomnography
- How many people
- 187 participants
- Where
- 1 siteBrazil
- Study dates
- 1 Apr 2020to 15 Mar 2021
- 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 1 year to 18 years
- All sexes
- Child, Adult
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.
Who may be able to join
- 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.
Who cannot join
- Participants who present a history of syndromes, neuromuscular or neurological disorders;
- Participants whose questionnaires were not completed.
Trial locations and contacts
1 site in 1 country.
Brazil1 site
Federal University of Pelotas
Pelotas, Rio Grande do Sul, 96015-560
About this study
Official title: 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.
Read the 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.
- Conditions
- Obstructive Sleep Apnea of Child
- Being tested
- Polysomnography
- Keywords
- diagnostic, polysomnography, sleep architecture, obstructive sleep apnea
- Medical subject headings
- Disease, Sleep Apnea, Obstructive
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
PolysomnographyDiagnostic 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).
| Study group | Role | What they receive |
|---|---|---|
| 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. Receives: Diagnostic Test: Polysomnography |
What is being measured
The primary outcome is the main question the study is designed to answer.
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).
Measured: day 1
Secondary outcomes (4)
Sociodemographic and clinical condition variables
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.
Measured: day 1
Sleep quality variables
Sleep Quality will be evaluated with the following questions:
- 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);
- 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);
- 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).
Measured: day 1
Sleep structure variables
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).
Measured: day 1
Sleep Bruxism detection
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).
Measured: day 1
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted31 Mar 2020
- Study start1 Apr 2020
- Primary completion1 Jul 2020
- Study completion15 Mar 2021
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (15)Papers the sponsor has linked to this study.
- Other trials for Obstructive Sleep Apnea of ChildStudies 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
- Case only
- Time perspective
- Cross-sectional
- Enrolment
- 187 participants (actual)
Sponsor and investigators
- Lead sponsor
- Federal University of Pelotas
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Noéli Boscato, PhD, Federal University of Pelotas
- Investigators
- Noéli Boscato, PhD, Principal investigator, Federal University of Pelotas
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04328402
- Sponsor's protocol ID
- FUPelotas6
- Status last verified
- Mar 2023
- First submitted
- 28 Mar 2020
- Last updated
- 16 Mar 2023
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Undecided
Publications
Garg RK, Afifi AM, Garland CB, Sanchez R, Mount DL. Pediatric Obstructive Sleep Apnea: Consensus, Controversy, and Craniofacial Considerations. Plast Reconstr Surg. 2017 Nov;140(5):987-997. doi: 10.1097/PRS.0000000000003752.
PubMed 29068938Kaditis AG, Alonso Alvarez ML, Boudewyns A, Alexopoulos EI, Ersu R, Joosten K, Larramona H, Miano S, Narang I, Trang H, Tsaoussoglou M, Vandenbussche N, Villa MP, Van Waardenburg D, Weber S, Verhulst S. Obstructive sleep disordered breathing in 2- to 18-year-old children: diagnosis and management. Eur Respir J. 2016 Jan;47(1):69-94. doi: 10.1183/13993003.00385-2015. Epub 2015 Nov 5.
PubMed 26541535Tan HL, Gozal D, Kheirandish-Gozal L. Obstructive sleep apnea in children: a critical update. Nat Sci Sleep. 2013 Sep 25;5:109-23. doi: 10.2147/NSS.S51907.
PubMed 24109201Baidas 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.
PubMed 30866906Andersen 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.
PubMed 30689039Baker 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.
PubMed 28241176Chen 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.
PubMed 31253409Sanchez 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.
PubMed 30725060Krzeski 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.
PubMed 30460910Goyal M, Johnson J. Obstructive Sleep Apnea Diagnosis and Management. Mo Med. 2017 Mar-Apr;114(2):120-124.
PubMed 30228558Certal 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.
PubMed 22886768Brietzke 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.
PubMed 15577775Abrishami 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.
PubMed 20143278De 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.
PubMed 24487608Pabla 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.
PubMed 29439747
Study at a glance
From the registry record, last updated by the sponsor on 16 Mar 2023. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Factors Correlated With Obstructive Sleep Apnea in Children and Adolescents Diagnosed by Polysomnography: Cross-sectional Study
- ClinicalTrials.gov ID
- NCT04328402
- Acronym / sponsor ID
- FUPelotas6
- Conditions
- Obstructive Sleep Apnea of Child
- Keywords
- diagnostic, polysomnography, sleep architecture, obstructive sleep apnea
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 187 participants (actual)
- Lead sponsor
- Federal University of PelotasUniversity, hospital or other
- Study start
- 1 Apr 2020 (actual)
- Primary completion
- 1 Jul 2020 (actual)
- Study completion
- 15 Mar 2021 (actual)
- First posted
- 31 Mar 2020 (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.
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.
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 design
- Observational model
- Case only
- Time perspective
- Cross-sectional
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Children and adolescents submitted to PSG in sleep laboratory | – | Diagnostic Test: PolysomnographyChildren (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. |
Who may qualify
- Ages
- 1 year to 18 years
- Sex
- All
- Age groups
- Child, Adult
- 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.
Key inclusion criteria (2 listed)
- 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.
Key exclusion criteria (2 listed)
- Participants who present a history of syndromes, neuromuscular or neurological disorders;
- Participants whose questionnaires were not completed.
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 |
|---|---|---|
| PolysomnographyPolysomnography, 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). | Diagnostic test | Children and adolescents submitted to PSG in sleep laboratory |
Primary outcome
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).
4 secondary outcomes
Sociodemographic and clinical condition variables
Time frame: day 1
Sleep quality variables
Time frame: day 1
Sleep structure variables
Time frame: day 1
Sleep Bruxism detection
Time frame: day 1
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 16 Mar 2023.
- Background: PubMed 29068938Garg RK, Afifi AM, Garland CB, Sanchez R, Mount DL. Pediatric Obstructive Sleep Apnea: Consensus, Controversy, and Craniofacial Considerations. Plast Reconstr Surg. 2017 Nov;140(5):987-997. doi: 10.1097/PRS.0000000000003752.
- Background: PubMed 26541535Kaditis AG, Alonso Alvarez ML, Boudewyns A, Alexopoulos EI, Ersu R, Joosten K, Larramona H, Miano S, Narang I, Trang H, Tsaoussoglou M, Vandenbussche N, Villa MP, Van Waardenburg D, Weber S, Verhulst S. Obstructive sleep disordered breathing in 2- to 18-year-old children: diagnosis and management. Eur Respir J. 2016 Jan;47(1):69-94. doi: 10.1183/13993003.00385-2015. Epub 2015 Nov 5.
- Background: PubMed 24109201Tan HL, Gozal D, Kheirandish-Gozal L. Obstructive sleep apnea in children: a critical update. Nat Sci Sleep. 2013 Sep 25;5:109-23. doi: 10.2147/NSS.S51907.
- Background: PubMed 30866906Baidas 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.
- Background: PubMed 30689039Andersen 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.
- Background: PubMed 28241176Baker 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.
- Background: PubMed 31253409Chen 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.
- Background: PubMed 30725060Sanchez 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.
- Background: PubMed 30460910Krzeski 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.
- Background: PubMed 30228558Goyal M, Johnson J. Obstructive Sleep Apnea Diagnosis and Management. Mo Med. 2017 Mar-Apr;114(2):120-124.
- Background: PubMed 22886768Certal 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.
- Background: PubMed 15577775Brietzke 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.
- Individual participant dataSharing planned: Undecided
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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.
Noéli Boscato, PhD principal investigator
Federal University of Pelotas
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 of Child, run by Federal University of Pelotas at 1 site in Brazil.
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 2 inclusion and 2 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 16 Mar 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 Brazil. 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 and severity of Obstructive Sleep Apnea (OSA) in children and adolescents evaluated by polysomnography (time frame: day 1). 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 NCT04328402, which also lists 15 linked publications.
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 16 Mar 2023.