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Leukotrienes Pathway in Chinese Children With Sleep-disordered Breathing

This study is enrolling participants by invitation only.
Sponsor:
Collaborator:
Merck
Information provided by:
Beijing Children's Hospital
ClinicalTrials.gov Identifier:
NCT01344746
First received: April 28, 2011
Last updated: NA
Last verified: August 2010
History: No changes posted
  Purpose

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.

  1. 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).

  2. 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.
  3. 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.
  4. 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.

Condition
Sleep-disordered Breathing

Study Type: Observational
Study Design: Observational Model: Case Control
Time Perspective: Prospective
Official Title: Leukotrienes Pathway in Chinese Children With Sleep-disordered Breathing

Resource links provided by NLM:

U.S. FDA Resources

Further study details as provided by Beijing Children's Hospital:

Biospecimen Retention:   Samples With DNA

blood and adenotonsillar tissue


Estimated Enrollment: 225
Study Start Date: December 2010
Estimated Study Completion Date: April 2012
Estimated Primary Completion Date: November 2011 (Final data collection date for primary outcome measure)
Groups/Cohorts
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.

  Show Detailed Description

  Eligibility

Ages Eligible for Study:   2 Years to 12 Years
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   Yes
Sampling Method:   Non-Probability Sample
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.

Criteria

Inclusion Criteria:

  • 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

Exclusion Criteria:

  • 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.
  Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: NCT01344746

Locations
China, Beijing
Beijing Children's Hospital
Beijing, Beijing, China, 100045
Sponsors and Collaborators
Beijing Children's Hospital
Merck
Investigators
Principal Investigator: Kunling Shen, MD Beijing Children's Hospital
  More Information

No publications provided

Responsible Party: Shen Kunling/President, Beijing Children's Hospital
ClinicalTrials.gov Identifier: NCT01344746     History of Changes
Other Study ID Numbers: MISP 38608
Study First Received: April 28, 2011
Last Updated: April 28, 2011
Health Authority: China: Food and Drug Administration

Keywords provided by Beijing Children's Hospital:
sleep-disordered breathing

Additional relevant MeSH terms:
Respiratory Aspiration
Sleep Apnea Syndromes
Respiration Disorders
Respiratory Tract Diseases
Signs and Symptoms, Respiratory
Signs and Symptoms
 Apnea
Sleep Disorders, Intrinsic
Dyssomnias
Sleep Disorders
Nervous System Diseases

ClinicalTrials.gov processed this record on May 22, 2013