Follow-up Studies of Primary Snoring(PS) and Obstructive Sleep Apnea Hypopnea Syndrome(OSAHS) in Chinese Children
NCT ID: NCT02447614
Last Updated: 2022-07-21
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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COMPLETED
500 participants
OBSERVATIONAL
2014-11-30
2022-07-01
Brief Summary
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Detailed Description
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Conditions
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Study Design
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COHORT
PROSPECTIVE
Study Groups
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Surgery
Adenotonsillectomy
Adenotonsillectomy
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
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
no treatment
just regular follow-up
no treatment
just regular follow-up
Interventions
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Adenotonsillectomy
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
no treatment
just regular follow-up
Eligibility Criteria
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Inclusion Criteria
Exclusion Criteria
* 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
3 Years
12 Years
ALL
No
Sponsors
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Beijing Children's Hospital
OTHER
Responsible Party
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Zhifei Xu
The chief of Sleep center
Principal Investigators
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Xu Zhifei, MD,PhD
Role: STUDY_DIRECTOR
Beijing Children's Hospital
Locations
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Sleep Center,Beijing Children's Hospital
Beijing, , China
Countries
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References
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Marcus CL, Brooks LJ, Draper KA, Gozal D, Halbower AC, Jones J, Schechter MS, Ward SD, Sheldon SH, Shiffman RN, Lehmann C, Spruyt K; American Academy of Pediatrics. Diagnosis and management of childhood obstructive sleep apnea syndrome. Pediatrics. 2012 Sep;130(3):e714-55. doi: 10.1542/peds.2012-1672. Epub 2012 Aug 27.
Xu Z, Li B, Shen K. Ambulatory blood pressure monitoring in Chinese children with obstructive sleep apnea/hypopnea syndrome. Pediatr Pulmonol. 2013 Mar;48(3):274-9. doi: 10.1002/ppul.22595. Epub 2012 May 21.
Tan 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.
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.
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.
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.
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.
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.
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.
Friedman BC, Goldman RD. Anti-inflammatory therapy for obstructive sleep apnea in children. Can Fam Physician. 2011 Aug;57(8):891-3.
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.
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.
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.
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.
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.
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.
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.
Other Identifiers
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BCH-OSAHS-002
Identifier Type: -
Identifier Source: org_study_id
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