Leukotrienes Pathway in Chinese Children With Sleep-disordered Breathing

NCT01344746 | Unknown DMC

• 1 other identifier: MISP 38608
• Study Type: observational
• Target: 225
• Locations: 1 country
• Sites: 1

Brief 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. The investigators have hypothesized that the pathophysiology of pediatric SDB involves specific systemic and local upper airway inflammatory response mediated by LTs.

1. 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.
2. 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. 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. 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.

Conditions

Sleep-disordered Breathing

Keywords

sleep-disordered breathing

Study Arms (2)

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.

Eligibility Criteria

• Age: 2 Years - 12 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Child (0-17)
• 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.

You may qualify if:

• 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

You may not qualify if:

• 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.

Sponsors & Collaborators

• Beijing Children's Hospital: lead
• Merck Sharp & Dohme LLC: collaborator

Study Sites (1)

Beijing Children's Hospital

Beijing, Beijing Municipality, 100045, China

Location

Biospecimen

Retention: SAMPLES WITH DNA

blood and adenotonsillar tissue

MeSH Terms

Conditions

Sleep Apnea Syndromes

Condition Hierarchy (Ancestors)

Apnea; Respiration Disorders; Respiratory Tract Diseases; Sleep Disorders, Intrinsic; Dyssomnias; Sleep Wake Disorders; Nervous System Diseases

Study Officials

• Kunling Shen, MD

  Beijing Children's Hospital

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: observational
• Observational Model: CASE CONTROL
• Time Perspective: PROSPECTIVE
• Sponsor Type: OTHER

Study Record Dates

• First Submitted: April 28, 2011
• First Posted: April 29, 2011
• Study Start: December 1, 2010
• Primary Completion: November 1, 2011
• Study Completion: April 1, 2012
• Last Updated: April 29, 2011

Record last verified: 2010-08

Locations

CN (1)