Sleep-disordered BreathingNCT01344746
Leukotrienes Pathway in Chinese Children With Sleep-disordered Breathing
An observational study of Sleep-disordered Breathing, run by Beijing Children's Hospital at 1 site in China.
Trial summary
Our goals are to demonstrate an active leukotrienes (LTs) mediated inflammatory response is involved in pathophysiology of sleep-disordered breathing (SDB), and to provide a theoretical evidence for LTs modify therapy in treating pediatric patients with SDB. Read more about this study
- Who is it for?
- Ages 2 to 12 yearsHealthy volunteers can take part
- Conditions the study is for
- Sleep-disordered Breathing
- How many people
- 225 participants
- Where
- 1 siteChina
- Study dates
- Dec 2010to Apr 2012
- 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 2 to 12 years
- All sexes
- Healthy volunteers accepted
- Child
Study population: Consecutive children referred to the sleep center for PSG due to symptoms of SDB from December 2009 to June 2010 were enrolled in the study. Normal age-, sex-, and weight-matched children without a history of snoring participated as control subjects, who were recruited from a community-based physical check-up activity.
Who may be able to join
- Subjects who were aged from 2 to 12 years ( 2 years ≤ subjects' age ≤ 12 years).
- Subjects who were in the presence of habitual snoring (snoring as reported by parents > 3 nights/week) and his/her history of habitual snoring were at least 3 months could be recruited in snoring group.
- Subjects who didn't have a history of snoring could be recruited as control subjects
Who cannot join
- Subjects who have cardiovascular, neuromuscular, craniofacial or genetic disorders; acute or chronic inflammation disease, e.g. asthma, allergic rhinitis or other allergies.
- Subjects who receive pharmacologic treatment including antibiotics, aspirin, nonsteroidal anti-inflammatory drugs, corticosteroids, and LTRAs within last 1 month.
- Subjects who already had undergone T\&A in the past.
- Subjects who were receiving oral appliances or CPAP (Continuous Positive Airway Pressure ) treatment.
Trial locations and contacts
1 site in 1 country.
About this study
Our goals are to demonstrate an active leukotrienes (LTs) mediated inflammatory response is involved in pathophysiology of sleep-disordered breathing (SDB), and to provide a theoretical evidence for LTs modify therapy in treating pediatric patients with SDB.
The investigators have hypothesized that the pathophysiology of pediatric SDB involves specific systemic and local upper airway inflammatory response mediated by LTs.
- LT concentration assays reveal higher levels in serum for both leukotriene B4 (LTB4) and cysteinyl leukotrienes (CysLTs) and in morning urine for LTE4 of SDB children, in comparison to healthy ones, and LTs productions emerge disease severity-dependent increases. There is a positive correlation between LTs production and other systemic markers such as neutrophil counts and high sensitive C-reactive protein (hsCRP).
- Children with SDB have higher leukotriene receptor-1 (LT1-R) and leukotriene receptor-2 (LT2-R) expressions in adenotonsillar tissues of SDB children compared to recurrent infectious tonsillitis subjects.
- Levels of LTs are positively correlated with body mass index (BMI) z-score, waist height ratio (WHtR), adenotonsillar size and polysomnography (PSG) indices including apnea-hypopnea index (AHI), obstructive apnea index (OAI), oxygen desaturation index (ODI), arousal index, percentage of time spend saturation lower than 90% (SLT90%) and negatively correlated with mean and minimal pulse oximetric saturation (SpO2), which indicates synergistic role of obesity and hypoxia are the determinants of LTs production in SDB.
- In adenotonsillar mixed cell culture system, the addition of LTs can increase cellular proliferation rates and exhibit dose-dependent responses, whereas leukotriene receptor antagonists (LTRAs) elicit dose-dependent cellular reductions.
Read the detailed description
Background:
SDB in children markedly differs from that seen in adults, in particular with respect to clinical manifestations, PSG (Polysomnography) findings, and treatment approaches. Pediatric SDB is due to a combination of increased upper airway resistance and repetitive pharyngeal collapsibility leading to intermittent hypoxemia and arousals during sleep. It is a common and highly prevalent disorder in pediatric age, affecting 4 to 11% of all children. If left untreated, it can result in serious morbid consequences including cardiovascular morbidity and neurocognitive dysfunction.
The etiology and pathophysiological mechanisms leading to SDB in childhood have not been clearly elucidated, but may include a complex interplay between anatomic (mainly adenotonsillar hypertrophy, ATH), neuromuscular factors and an underlying genetic predisposition toward the disease. However, more evidences have identified that both local airway and systemic inflammation also contribute to its pathogenesis.
Among major inflammatory mediators, leukotrienes (LTs) are a class of closely structurally related lipid compounds that derive from the 5-lipoxygenase pathway of arachidonic acid metabolism. The LTs family includes LTA4, LTB4 and LTC4/D4/E4 (cysLTs), all of which are potent leukocytes chemoattractants and activators. LTA4, an unstable intermediate, can be further metabolized to LTB4 or cysLTs. LTC4 and LTD4 both have very short half-lives, whereas LTE4 appears to be most stable. The effects of mediators occur after their interaction with receptors.
Recent investigations in western countries have revealed LTs may be involved in the pathogenesis of SDB, and accelerate the progress of the disease by exacerbating local inflammatory response, then promoting the proliferation of the upper airway lymphoid tissues. And in the later pediatric investigation, it was determined that LTs production emerged disease severity-dependent increases in exhaled breath condensate of SDB patients. Nevertheless, few studies have investigated the role of LTs in systemic inflammation of SDB, and whether LTs productions is a independent risk factor of SDB, or is a obesity-dependent or ATH -dependent risk factor of SDB remains controversial. Moreover, no research work in China has been carried out to investigate the LTs pathway in a large population of Chinese snoring children with SDB.
Participants:
Consecutive children referred to the sleep center for PSG due to symptoms of SDB from December 2009 to June 2010 were enrolled in the study. Normal age-, sex-, and weight-matched children without a history of snoring participated as control subjects, who were recruited from a community-based physical check-up activity.
Grouping:
Five groups of participants were formed:
- Snoring group:
- Subjects with snoring and AHI ≥ 20 episodes/h (severe SDB).
- Snorers with AHI < 20 episodes/h and ≥ 5 episodes/h (moderate SDB)
- Snorers with AHI < 5 episodes/h and ≥ 1 episodes/h (mild SDB)
- Non-snoring control group:
- When testing serum and urinal samples, healthy children without snoring will be chosen as controls.
- When testing lymphoid tissue samples, patients with recurrent infectious tonsillitis (at least five tonsillar infections in less than 6 months) but without snoring will be selected as controls before surgery and recruited to the study, because adenotonsillar tissue can't be obtained from normal children for obvious ethical reasons.
The five study groups having at least 45 participants respectively will be compared regarding subjects' characteristics, PSG indices, metabolic and inflammatory variables.
Statistical Methods:
- Data are presented as mean ± SD or median (interquartile range) depending on the distribution unless stated otherwise. PSG indexes, hsCRP values and LT concentrations will be log-transformed (natural logarithm) and SpO2 will be logit-transformed to correct for skewed distribution.
- One-way analysis of variance followed by post hoc tests for pair comparisons (Bonferroni test) will be used for continuous variables and X2 test (Yates correction) for categorical characteristics. If data can't be transformed to approach normal distribution, Kruskal-Wallis test followed by nonparametric Bonferroni multiple comparison test will be applied.
- Correlations will be analyzed without adjustment by using Pearson correlation or spearman rank test depending on data distribution. Partial correlation will be applied to assess the linear association of LTs concentrations with other systemic inflammatory marks and PSG indices after adjustment for covariates including age, glucose, lipids, and BMI z-score.
- Stepwise multiple regressions will be performed to identify independent predictors of LTs production.
- All statistical analyses will be conducted using statistical software (version 16.0; SPSS, Chicago, IL, USA). Using Dunnett's test, a two-tailed p value < 0.01 was considered statistically significant.
- Conditions
- Sleep-disordered Breathing
- Keywords
- sleep-disordered breathing
- Medical subject headings
- Sleep Apnea Syndromes
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
| Study group | Role | What they receive |
|---|---|---|
| Snoring group | 1. Subjects with snoring and AHI ≥ 20 episodes/h (severe SDB). 2. Snorers with AHI < 20 episodes/h and ≥ 5 episodes/h (moderate SDB) 3. Snorers with AHI < 5 episodes/h and ≥ 1 episodes/h (mild SDB) | |
| Non-snoring group | * When testing serum and urinal samples, healthy children without snoring will be chosen as controls. * When testing lymphoid tissue samples, patients with recurrent infectious tonsillitis (at least five tonsillar infections in less than 6 months) but without snoring will be selected as controls before surgery and recruited to the study, because adenotonsillar tissue can't be obtained from normal children for obvious ethical reasons. |
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted29 Apr 2011 (estimated)
- Study startDec 2010
- Primary completionNov 2011 (estimated)
- Study completionApr 2012 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Sleep-disordered BreathingStudies 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-control
- Time perspective
- Prospective
- Enrolment
- 225 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Beijing Children's Hospital
- Sponsor type
- University, hospital or other
- Collaborators
- Merck Sharp & Dohme LLC
- Investigators
- Kunling Shen, MD, Principal investigator, Beijing Children's Hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01344746
- Sponsor's protocol ID
- MISP 38608
- Status last verified
- Aug 2010
- First submitted
- 28 Apr 2011
- Last updated
- 29 Apr 2011
- Results posted
- No
- Data monitoring committee
- Yes
Study at a glance
From the registry record, last updated by the sponsor on 29 Apr 2011. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Leukotrienes Pathway in Chinese Children With Sleep-disordered Breathing
- ClinicalTrials.gov ID
- NCT01344746
- Acronym / sponsor ID
- MISP 38608
- Conditions
- Sleep-disordered Breathing
- Keywords
- sleep-disordered breathing
- Study type
- Observational
- Recruitment status
- Unknown status
- Enrolment
- 225 participants (estimated)
- Lead sponsor
- Beijing Children's HospitalUniversity, hospital or other
- Collaborators
- Merck Sharp & Dohme LLC
- Study start
- Dec 2010
- Primary completion
- Nov 2011 (estimated)
- Study completion
- Apr 2012 (estimated)
- First posted
- 29 Apr 2011 (estimated)
- 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.
Our goals are to demonstrate an active leukotrienes (LTs) mediated inflammatory response is involved in pathophysiology of sleep-disordered breathing (SDB), and to provide a theoretical evidence for LTs modify therapy in treating pediatric patients with SDB.
The investigators have hypothesized that the pathophysiology of pediatric SDB involves specific systemic and local upper airway inflammatory response mediated by LTs.
- LT concentration assays reveal higher levels in serum for both leukotriene B4 (LTB4) and cysteinyl leukotrienes (CysLTs) and in morning urine for LTE4 of SDB children, in comparison to healthy ones, and LTs productions emerge disease severity-dependent increases. There is a positive correlation between LTs production and other systemic markers such as neutrophil counts and high sensitive C-reactive protein (hsCRP).
- Children with SDB have higher leukotriene receptor-1 (LT1-R) and leukotriene receptor-2 (LT2-R) expressions in adenotonsillar tissues of SDB children compared to recurrent infectious tonsillitis subjects.
- Levels of LTs are positively correlated with body mass index (BMI) z-score, waist height ratio (WHtR), adenotonsillar size and polysomnography (PSG) indices including apnea-hypopnea index (AHI), obstructive apnea index (OAI), oxygen desaturation index (ODI), arousal index, percentage of time spend saturation lower than 90% (SLT90%) and negatively correlated with mean and minimal pulse oximetric saturation (SpO2), which indicates synergistic role of obesity and hypoxia are the determinants of LTs production in SDB.
- In adenotonsillar mixed cell culture system, the addition of LTs can increase cellular proliferation rates and exhibit dose-dependent responses, whereas leukotriene receptor antagonists (LTRAs) elicit dose-dependent cellular reductions.
Detailed description
Background:
SDB in children markedly differs from that seen in adults, in particular with respect to clinical manifestations, PSG (Polysomnography) findings, and treatment approaches. Pediatric SDB is due to a combination of increased upper airway resistance and repetitive pharyngeal collapsibility leading to intermittent hypoxemia and arousals during sleep. It is a common and highly prevalent disorder in pediatric age, affecting 4 to 11% of all children. If left untreated, it can result in serious morbid consequences including cardiovascular morbidity and neurocognitive dysfunction.
The etiology and pathophysiological mechanisms leading to SDB in childhood have not been clearly elucidated, but may include a complex interplay between anatomic (mainly adenotonsillar hypertrophy, ATH), neuromuscular factors and an underlying genetic predisposition toward the disease. However, more evidences have identified that both local airway and systemic inflammation also contribute to its pathogenesis.
Among major inflammatory mediators, leukotrienes (LTs) are a class of closely structurally related lipid compounds that derive from the 5-lipoxygenase pathway of arachidonic acid metabolism. The LTs family includes LTA4, LTB4 and LTC4/D4/E4 (cysLTs), all of which are potent leukocytes chemoattractants and activators. LTA4, an unstable intermediate, can be further metabolized to LTB4 or cysLTs. LTC4 and LTD4 both have very short half-lives, whereas LTE4 appears to be most stable. The effects of mediators occur after their interaction with receptors.
Recent investigations in western countries have revealed LTs may be involved in the pathogenesis of SDB, and accelerate the progress of the disease by exacerbating local inflammatory response, then promoting the proliferation of the upper airway lymphoid tissues. And in the later pediatric investigation, it was determined that LTs production emerged disease severity-dependent increases in exhaled breath condensate of SDB patients. Nevertheless, few studies have investigated the role of LTs in systemic inflammation of SDB, and whether LTs productions is a independent risk factor of SDB, or is a obesity-dependent or ATH -dependent risk factor of SDB remains controversial. Moreover, no research work in China has been carried out to investigate the LTs pathway in a large population of Chinese snoring children with SDB.
Participants:
Consecutive children referred to the sleep center for PSG due to symptoms of SDB from December 2009 to June 2010 were enrolled in the study. Normal age-, sex-, and weight-matched children without a history of snoring participated as control subjects, who were recruited from a community-based physical check-up activity.
Grouping:
Five groups of participants were formed:
- Snoring group:
- Subjects with snoring and AHI ≥ 20 episodes/h (severe SDB).
- Snorers with AHI < 20 episodes/h and ≥ 5 episodes/h (moderate SDB)
- Snorers with AHI < 5 episodes/h and ≥ 1 episodes/h (mild SDB)
- Non-snoring control group:
- When testing serum and urinal samples, healthy children without snoring will be chosen as controls.
- When testing lymphoid tissue samples, patients with recurrent infectious tonsillitis (at least five tonsillar infections in less than 6 months) but without snoring will be selected as controls before surgery and recruited to the study, because adenotonsillar tissue can't be obtained from normal children for obvious ethical reasons.
The five study groups having at least 45 participants respectively will be compared regarding subjects' characteristics, PSG indices, metabolic and inflammatory variables.
Statistical Methods:
- Data are presented as mean ± SD or median (interquartile range) depending on the distribution unless stated otherwise. PSG indexes, hsCRP values and LT concentrations will be log-transformed (natural logarithm) and SpO2 will be logit-transformed to correct for skewed distribution.
- One-way analysis of variance followed by post hoc tests for pair comparisons (Bonferroni test) will be used for continuous variables and X2 test (Yates correction) for categorical characteristics. If data can't be transformed to approach normal distribution, Kruskal-Wallis test followed by nonparametric Bonferroni multiple comparison test will be applied.
- Correlations will be analyzed without adjustment by using Pearson correlation or spearman rank test depending on data distribution. Partial correlation will be applied to assess the linear association of LTs concentrations with other systemic inflammatory marks and PSG indices after adjustment for covariates including age, glucose, lipids, and BMI z-score.
- Stepwise multiple regressions will be performed to identify independent predictors of LTs production.
- All statistical analyses will be conducted using statistical software (version 16.0; SPSS, Chicago, IL, USA). Using Dunnett's test, a two-tailed p value < 0.01 was considered statistically significant.
Study design
- Observational model
- Case-control
- Time perspective
- Prospective
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Snoring group | – | –1. Subjects with snoring and AHI ≥ 20 episodes/h (severe SDB). 2. Snorers with AHI < 20 episodes/h and ≥ 5 episodes/h (moderate SDB) 3. Snorers with AHI < 5 episodes/h and ≥ 1 episodes/h (mild SDB) |
| Non-snoring group | – | –* When testing serum and urinal samples, healthy children without snoring will be chosen as controls. * When testing lymphoid tissue samples, patients with recurrent infectious tonsillitis (at least five tonsillar infections in less than 6 months) but without snoring will be selected as controls before surgery and recruited to the study, because adenotonsillar tissue can't be obtained from normal children for obvious ethical reasons. |
Who may qualify
- Ages
- 2 to 12 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Child
- Study population
- Consecutive children referred to the sleep center for PSG due to symptoms of SDB from December 2009 to June 2010 were enrolled in the study. Normal age-, sex-, and weight-matched children without a history of snoring participated as control subjects, who were recruited from a community-based physical check-up activity.
Key inclusion criteria (3 listed)
- Subjects who were aged from 2 to 12 years ( 2 years ≤ subjects' age ≤ 12 years).
- Subjects who were in the presence of habitual snoring (snoring as reported by parents > 3 nights/week) and his/her history of habitual snoring were at least 3 months could be recruited in snoring group.
- Subjects who didn't have a history of snoring could be recruited as control subjects
Key exclusion criteria (4 listed)
- Subjects who have cardiovascular, neuromuscular, craniofacial or genetic disorders; acute or chronic inflammation disease, e.g. asthma, allergic rhinitis or other allergies.
- Subjects who receive pharmacologic treatment including antibiotics, aspirin, nonsteroidal anti-inflammatory drugs, corticosteroids, and LTRAs within last 1 month.
- Subjects who already had undergone T\&A in the past.
- Subjects who were receiving oral appliances or CPAP (Continuous Positive Airway Pressure ) treatment.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Primary outcome
Not reported in the source record.
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 29 Apr 2011.
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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.
Kunling Shen, MD principal investigator
Beijing Children's Hospital
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 Sleep-disordered Breathing, run by Beijing Children's Hospital at 1 site in China.
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 3 inclusion and 4 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: status not confirmed, as of the sponsor's last update on 29 Apr 2011. 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 China. 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?
Results are not available in the source record.
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.
Where can I read the original study information?
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 29 Apr 2011; AzTrials last refreshed its copy on 7 Nov 2026.