Follow-up Studies of Primary Snoring(PS) and Obstructive Sleep Apnea Hypopnea Syndrome(OSAHS) in Chinese Children

NCT02447614 | Completed DMC

• 1 other identifier: BCH-OSAHS-002
• Study Type: observational
• Target: 500
• Locations: 1 country
• Sites: 1

Brief Summary

The study is designed to investigate the natural course of Primary snoring in 1-2 years or more and the different effect of drug and surgical treatment applied in children with obstructive sleep apnea (OSAS) by comparing the polysomnography(PSG) and sleep questionaires in 6 months after treatment.

Conditions

Obstructive Sleep Apnea Syndrome

Keywords

follow up; Primary Snoring; Obstructive Sleep Apnea Syndrome

Outcome Measures

Primary Outcomes (1)

• The changes of PSG parameters of children with PS or OSAS

  In our study, there are 55 children of mild to moderate SDB with conservative treatment, among which 23 children are chosen in PS group and 32 children are chosen in OSAS group. For PSG, according to the value of OAHI to determine the improvement of the child, the value of OAHI is decreased by ≥ 25% for improvement. In the PS group, there were 2 cases with improvement, and the corresponding remission rate was 8.7%. In the OSAS group, there are 22 cases with improvement, and the corresponding remission rate was 68.8%. There was a significant difference between the remission rate of PS group and that of OSAS group (P\<0.001).

  6 months

Secondary Outcomes (3)

• The changes of sleep questionnaires of children with PS or OSAS

  3 months, 6 months, 12 months

• The changes of level of leukotriene in urine of children with PS or OSAS

  6 months

• The high-sensitivity CRP and Heart rate variability (HRV) of children with SDB

  0 months

Other Outcomes (2)

• The pictorial memory task acquisition and retention in children with SDB

  0 month

• The endothelial cell function in children with PS or OSAS

  0 month

Study Arms (3)

Surgery

Adenotonsillectomy

Procedure: Adenotonsillectomy

Conservative treatment

Mometasone Furoate Aqueous Nasal Spray or uticasone propionate (1/once qd) and（or）Leukotriene antagonists(4 or 5mg/once qn) or H1 receptor antagonists

Other: Conservative treatment

no treatment

just regular follow-up

Other: no treatment

Interventions

Adenotonsillectomy PROCEDURE

Adenotonsillectomy

Surgery

Conservative treatment OTHER

Mometasone Furoate Aqueous Nasal Spray or uticasone propionate (1/once qd) and（or）Leukotriene antagonists(4 or 5mg/once qn) or H1 receptor antagonists

Conservative treatment

no treatment OTHER

just regular follow-up

no treatment

Eligibility Criteria

• Age: 3 Years - 12 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Child (0-17)
• Sampling Method: Non-Probability Sample

Study Population

PS and OSAHS in Chinese children

You may qualify if:

• Children aged 3-12 yrs, who are referred for clinical evaluation of habitual snoring and who were scheduled for an overnight polysomnogram.

You may not qualify if:

• Children who are suffered from any chronic medical or psychiatric condition
• Children with acute respiratory infection
• Children with severe craniofacial deformities
• Children with cardiopulmonary diseases
• Children with a genetic syndrome that was known to affect cognitive abilities, or are receiving medications that are known to interfere with memory or sleep onset or heat rate

Sponsors & Collaborators

• Beijing Children's Hospital: lead

Study Sites (1)

Sleep Center,Beijing Children's Hospital

Beijing, 100045, China

Location

Related Publications (17)

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• Kohler M. Risk factors and treatment for obstructive sleep apnea amongst obese children and adults. Curr Opin Allergy Clin Immunol. 2009 Feb;9(1):4-9. doi: 10.1097/ACI.0b013e32831d8184.

  PMID: 19532087 BACKGROUND

• Cheng J, Elden L. Outcomes in children under 12 months of age undergoing adenotonsillectomy for sleep-disordered breathing. Laryngoscope. 2013 Sep;123(9):2281-4. doi: 10.1002/lary.23796. Epub 2013 Jul 2.

  PMID: 23821577 BACKGROUND

• Tagaya M, Nakata S, Yasuma F, Mitchell RB, Sasaki F, Miyazaki S, Morinaga M, Otake H, Teranishi M, Nakashima T. Children with severe or moderate obstructive sleep apnoea syndrome show a high incidence of persistence after adenotonsillectomy. Acta Otolaryngol. 2012 Nov;132(11):1208-14. doi: 10.3109/00016489.2012.695088. Epub 2012 Oct 1.

  PMID: 23025449 BACKGROUND

• Shen Y, Xu Z, Shen K. Urinary leukotriene E4, obesity, and adenotonsillar hypertrophy in Chinese children with sleep disordered breathing. Sleep. 2011 Aug 1;34(8):1135-041. doi: 10.5665/SLEEP.1178.

  PMID: 21804676 BACKGROUND

• Shen Y, Xu Z, Huang Z, Xu J, Qin Q, Shen K. Increased cysteinyl leukotriene concentration and receptor expression in tonsillar tissues of Chinese children with sleep-disordered breathing. Int Immunopharmacol. 2012 Aug;13(4):371-6. doi: 10.1016/j.intimp.2012.05.009. Epub 2012 May 23.

  PMID: 22634478 BACKGROUND

• Tapia IE, Marcus CL. Newer treatment modalities for pediatric obstructive sleep apnea. Paediatr Respir Rev. 2013 Sep;14(3):199-203. doi: 10.1016/j.prrv.2012.05.006. Epub 2012 Jun 26.

  PMID: 23931720 BACKGROUND

• Friedman BC, Goldman RD. Anti-inflammatory therapy for obstructive sleep apnea in children. Can Fam Physician. 2011 Aug;57(8):891-3.

  PMID: 21841108 BACKGROUND

• Kheirandish-Gozal L, Kim J, Goldbart AD, Gozal D. Novel pharmacological approaches for treatment of obstructive sleep apnea in children. Expert Opin Investig Drugs. 2013 Jan;22(1):71-85. doi: 10.1517/13543784.2013.735230. Epub 2012 Nov 5.

  PMID: 23126687 BACKGROUND

• Rosen D. Management of obstructive sleep apnea associated with Down syndrome and other craniofacial dysmorphologies. Curr Opin Pulm Med. 2011 Nov;17(6):431-6. doi: 10.1097/MCP.0b013e32834ba9c0.

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• Heussler H, Chan P, Price AM, Waters K, Davey MJ, Hiscock H. Pharmacological and non-pharmacological management of sleep disturbance in children: an Australian Paediatric Research Network survey. Sleep Med. 2013 Feb;14(2):189-94. doi: 10.1016/j.sleep.2012.09.023. Epub 2012 Dec 12.

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• Goldbart AD, Greenberg-Dotan S, Tal A. Montelukast for children with obstructive sleep apnea: a double-blind, placebo-controlled study. Pediatrics. 2012 Sep;130(3):e575-80. doi: 10.1542/peds.2012-0310. Epub 2012 Aug 6.

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• Leboulanger N, Fauroux B. Non-invasive positive-pressure ventilation in children in otolaryngology. Eur Ann Otorhinolaryngol Head Neck Dis. 2013 Apr;130(2):73-7. doi: 10.1016/j.anorl.2012.06.001. Epub 2012 Dec 27.

  PMID: 23273417 BACKGROUND

• Wu Y, Zheng L, Wu P, Tang Y, Xu Z, Ni X. Clinical and PSG Characteristics of Children with Mild OSA and Respiratory Events Terminated Predominantly with Arousal. Can Respir J. 2021 Jun 7;2021:5549423. doi: 10.1155/2021/5549423. eCollection 2021.

  PMID: 34194586 DERIVED

• Zhang F, Wu Y, Feng G, Ni X, Xu Z, Gozal D. Polysomnographic correlates of endothelial function in children with obstructive sleep apnea. Sleep Med. 2018 Dec;52:45-50. doi: 10.1016/j.sleep.2018.07.023. Epub 2018 Aug 22.

  PMID: 30269047 DERIVED

Biospecimen

Retention: SAMPLES WITHOUT DNA

urine

MeSH Terms

Conditions

Sleep Apnea, Obstructive

Interventions

Conservative Treatment

Condition Hierarchy (Ancestors)

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

Intervention Hierarchy (Ancestors)

Therapeutics

Study Officials

• Xu Zhifei, MD,PhD

  Beijing Children's Hospital

  STUDY DIRECTOR

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: PROSPECTIVE
• Target Duration: 6 Years
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: The chief of Sleep center

Study Record Dates

• First Submitted: May 13, 2015
• First Posted: May 19, 2015
• Study Start: November 1, 2014
• Primary Completion: June 1, 2022
• Study Completion: July 1, 2022
• Last Updated: July 21, 2022

Record last verified: 2022-07

Data Sharing

• IPD Sharing: Will not share

Locations

CN (1)