The combination of atomoxetine and oxybutynin for the treatment of obstructive sleep apnea in children with Down syndrome.
Down syndrome
obstructive sleep apnea
Journal
Journal of clinical sleep medicine : JCSM : official publication of the American Academy of Sleep Medicine
ISSN: 1550-9397
Titre abrégé: J Clin Sleep Med
Pays: United States
ID NLM: 101231977
Informations de publication
Date de publication:
01 Dec 2023
01 Dec 2023
Historique:
pmc-release:
01
12
2024
medline:
4
12
2023
pubmed:
9
8
2023
entrez:
9
8
2023
Statut:
ppublish
Résumé
Children with Down syndrome (DS) are at very high risk for obstructive sleep apnea (OSA). Current OSA treatments have limited effectiveness in this population. We evaluated the effectiveness of atomoxetine and oxybutynin (ato-oxy) to treat OSA in children with Down syndrome. Children ages 6-7 years old with Down syndrome and OSA participated in a double-blind crossover clinical trial evaluating two dose regimens of ato-oxy. Participants received low-dose ato-oxy (0.5 mg/kg atomoxetine and 5 mg oxybutynin) and high-dose ato-oxy (1.2 mg/kg atomoxetine and 5 mg oxybutynin) for 1 month in random order. The primary study outcome was change in obstructive apnea-hypopnea index. Health-related quality of life as measured by the OSA-18 as well as changes in sleep architecture were secondary outcomes. Fifteen participants qualified for randomization and 11 participants had complete data at all points. Baseline obstructive apnea-hypopnea index was 7.4 ± 3.7 (mean ± standard deviation), obstructive apnea-hypopnea index with low-dose ato-oxy was 3.6 ± 3.3 ( Ato-oxy is a promising treatment for OSA in children with Down syndrome. Registry: Clinicaltrials.gov; Name: Medications for Obstructive Sleep Apnea In Children With Down Syndrome (MOSAIC); URL: https://clinicaltrials.gov/ct2/show/NCT04115878; Identifier: NCT04115878. Combs D, Edgin J, Hsu C-H, et al. The combination of atomoxetine and oxybutynin for the treatment of obstructive sleep apnea in children with Down syndrome.
Identifiants
pubmed: 37555595
pii: jcsm.10764
doi: 10.5664/jcsm.10764
pmc: PMC10692944
doi:
Substances chimiques
Atomoxetine Hydrochloride
57WVB6I2W0
oxybutynin
K9P6MC7092
Banques de données
ClinicalTrials.gov
['NCT04115878']
Types de publication
Randomized Controlled Trial
Journal Article
Langues
eng
Sous-ensembles de citation
IM
Pagination
2065-2073Informations de copyright
© 2023 American Academy of Sleep Medicine.
Références
PLoS One. 2011 Mar 17;6(3):e16924
pubmed: 21437285
Arch Pediatr Adolesc Med. 2003 Jul;157(7):655-60
pubmed: 12860786
Med Care. 2001 Aug;39(8):800-12
pubmed: 11468499
Res Dev Disabil. 2014 Jun;35(6):1412-24
pubmed: 24732041
Sleep Med. 2016 Nov - Dec;27-28:99-106
pubmed: 27938928
J Pediatr. 2017 Oct;189:98-104.e1
pubmed: 28751125
J Intellect Disabil Res. 2013 Nov;57(11):1050-7
pubmed: 22974061
Endocrinol Diabetes Metab. 2020 Aug 08;4(2):e00148
pubmed: 33855195
Am J Respir Crit Care Med. 2006 Dec 1;174(11):1264-73
pubmed: 16931636
Am J Intellect Dev Disabil. 2019 Jan;124(1):4-10
pubmed: 30715921
Curr Opin Pulm Med. 2009 Nov;15(6):585-90
pubmed: 19713846
Birth Defects Res A Clin Mol Teratol. 2010 Dec;88(12):1008-16
pubmed: 20878909
Am J Respir Crit Care Med. 2013 Feb 1;187(3):311-9
pubmed: 23220910
Pediatr Pulmonol. 2018 Oct;53(10):1414-1421
pubmed: 29992744
Cardiol Young. 2023 Sep;33(9):1678-1685
pubmed: 36184834
Sleep Med Rev. 2022 Aug;64:101649
pubmed: 35709641
Pediatrics. 2012 Sep;130(3):576-84
pubmed: 22926173
Otolaryngol Head Neck Surg. 2000 Jul;123(1 Pt 1):9-16
pubmed: 10889473
J Pediatr. 2010 Jul;157(1):57-61
pubmed: 20304429
Pediatrics. 2006 Mar;117(3):e442-51
pubmed: 16510622
J Intellect Disabil Res. 2014 Sep;58(9):800-9
pubmed: 24001184
Arch Dis Child. 2019 Mar;104(3):275-279
pubmed: 30072363
Am J Respir Crit Care Med. 2019 May 15;199(10):1267-1276
pubmed: 30395486
JAMA Otolaryngol Head Neck Surg. 2022 Jun 1;148(6):522-528
pubmed: 35446411
J Clin Sleep Med. 2009 Aug 15;5(4):317-23
pubmed: 19968008
J Clin Sleep Med. 2022 Dec 1;18(12):2837-2844
pubmed: 35975547
Sleep. 2016 Mar 01;39(3):699-704
pubmed: 26612391
Ann Am Thorac Soc. 2023 Apr;20(4):584-595
pubmed: 36538809
Int J Pediatr Otorhinolaryngol. 2010 Mar;74(3):241-4
pubmed: 20097432
Psychother Psychosom. 2016;85(5):270-88
pubmed: 27508501
Pharmacotherapy. 2017 Feb;37(2):214-220
pubmed: 27931082
Respirology. 2023 Mar;28(3):273-280
pubmed: 36184258
Am J Intellect Dev Disabil. 2017 May;122(3):247-281
pubmed: 28452584
Ambul Pediatr. 2003 Nov-Dec;3(6):329-41
pubmed: 14616041
Sleep Breath. 2023 May;27(2):495-503
pubmed: 35551600
CNS Drugs. 2016 Jul;30(7):603-28
pubmed: 27290715
Int J Pediatr Otorhinolaryngol. 2015 Jul;79(7):1013-6
pubmed: 25959405
N Engl J Med. 2013 Jun 20;368(25):2366-76
pubmed: 23692173
Laryngoscope. 2021 Nov;131(11):2598-2602
pubmed: 33860943
Arch Otolaryngol Head Neck Surg. 2006 Apr;132(4):432-6
pubmed: 16618913
J Clin Sleep Med. 2020 Jun 15;16(6):899-906
pubmed: 32043964
AJR Am J Roentgenol. 2004 Jul;183(1):175-81
pubmed: 15208134