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  • 1
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    0796 Safety and efficacy of the combination of atomoxetine and oxybutynin for OSA treatment in children with Down Syndrome
    Oxford University Press (OUP) ; 2023
    In:  SLEEP Vol. 46, No. Supplement_1 ( 2023-05-29), p. A351-A351
    Details
    In: SLEEP, Oxford University Press (OUP), Vol. 46, No. Supplement_1 ( 2023-05-29), p. A351-A351
    Abstract: Children with Down syndrome (DS) are at very high risk for obstructive sleep apnea (OSA), with a prevalence of OSA of 50-79%. Current OSA treatments for children with DS have limited effectiveness, as positive airway pressure therapy is poorly tolerated and adenotonsillectomy is not curative in most children with DS. The combination of atomoxetine and oxybutynin (ato-oxy) is a promising OSA treatment in adults. Ato-oxy has been shown to improve upper airway hypotonia, a key feature of OSA in children with DS, thus it may be particularly effective for OSA in children with DS. Methods We performed a randomized, double-blind, crossover pilot trial examining the short-term efficacy of ato-oxy in 15 children aged 6 to 17 years with DS and OSA. Participants received 4 weeks of low dose (0.5 mg/kg atomoxetine and 5 mg oxybutynin) as well as 4 weeks of high dose (1.2 mg/kg atomoxetine and 5 mg oxybutynin) in random order. Participants underwent polysomnography as well as parent-reported health-related quality of life assessment using the OSA-18 at baseline and at the end of each dosing period. The primary study endpoint was reduction in obstructive apnea-hypopnea index (oAHI) from baseline. Paired t-tests were used to compare baseline to low and high dose ato-oxy. Results 15 participants qualified for randomization and 11 participants had complete data at all points. Baseline oAHI was 7.4 ± 3.7 (mean ± standard deviation), oAHI with low dose ato-oxy was 3.6 ± 3.3 (p=0.001 vs baseline) and oAHI with high dose ato-oxy was 3.9 ± 2.8 (p=0.003 vs baseline). There were no differences in sleep architecture or sleep efficiency between baseline and either dose of ato-oxy. OSA-18 total score was 51.5 ± 18.5 at baseline; improved to 44.6 ± 17.0 (p=0.09) at the end of 4-weeks of low dose ato-oxy; and improved to 45.5 ± 15.7 (p=0.37) at the end of high-dose ato-oxy therapy. The most common adverse effects were irritability and fatigue, and these were generally mild. Conclusion Ato-oxy is a promising treatment for OSA in children with DS. Support (if any) Funding provided by NIH (HL151254 and HD109777) as well as the Lumind-IDSC foundation.
    Type of Medium: Online Resource
    ISSN: 0161-8105 , 1550-9109
    URL: Article
    DOI: 10.1093/sleep/zsad077.0796
    Language: English
    Publisher: Oxford University Press (OUP)
    Publication Date: 2023
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  • 2
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    0772 OSA Improvement Due to Ato-oxy in Children with down Syndrome Predicts Improved Quality of Life
    Oxford University Press (OUP) ; 2024
    In:  SLEEP Vol. 47, No. Supplement_1 ( 2024-04-20), p. A331-A331
    Details
    In: SLEEP, Oxford University Press (OUP), Vol. 47, No. Supplement_1 ( 2024-04-20), p. A331-A331
    Abstract: Obstructive sleep apnea (OSA) is highly prevalent in children with Down syndrome (DS). Current OSA treatments for children with DS have limited effectiveness, as positive airway pressure therapy is poorly tolerated and adenotonsillectomy is not curative in most children with DS. We recently showed that the combination of atomoxetine and oxybutynin (ato-oxy) reduced OSA severity by 51% in a small trial of children with DS. Health-related quality of life (HRQOL) scores improved with ato-oxy, but the improvement was not statistically significant when examined across all trial participants. Therefore we evaluated if HRQOL improvements were greater in participants with more significant improvement in OSA. Methods We compared baseline characteristics and changes in HR-QOL in children with DS age 7-17 years old who had a response (defined as obstructive apnea-hypopnea index [oAHI] improvement of & gt;50% and reduction of oAHI to & lt; 5 events/hour) vs. those who did not respond to ato-oxy. Participants received 4 weeks of ato-oxy (0.5 mg/kg atomoxetine and 5 mg oxybutynin) with polysomnography and assessment of HR-QOL using the PedsQL along with behavioral assessment using the Conners at baseline and after 4 weeks of treatment. Paired t-tests or chi square tests were used to compare baseline participant characteristics and linear regression with adjustment for baseline was used to compare treatment outcomes. Results 12 participants had data at both baseline and on ato-oxy. 42% of participants had a significant response to ato-oxy. There were no significant differences at baseline between treatment responders and non-responders in demographics, body mass index or OSA severity. Quality of life was significantly higher in ato-oxy responders compared to non-responders. Adjusted mean total PedsQL score was 75 (95% confidence interval: 64, 87) in responders compared to 61 (51, 70) in non-responders, p=0.048. Responders had better scores across Conners domains including attention and behavior, but these were not statistically significant compared to non-responders. Conclusion No characteristics predicted ato-oxy response for OSA treatment in children with DS. Children who had a significant response to ato-oxy had significant improvement in their quality of life. Support (if any) Funding provided by NIH (HL151254 and HD109777) as well as the Lumind-IDSC foundation.
    Type of Medium: Online Resource
    ISSN: 0161-8105 , 1550-9109
    URL: Article
    DOI: 10.1093/sleep/zsae067.0772
    Language: English
    Publisher: Oxford University Press (OUP)
    Publication Date: 2024
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  • 3
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    Differences in sleep timing and related effects between African Americans and non-Hispanic Whites
    American Academy of Sleep Medicine (AASM) ; 2021
    In:  Journal of Clinical Sleep Medicine Vol. 17, No. 5 ( 2021-05), p. 897-908
    Details
    In: Journal of Clinical Sleep Medicine, American Academy of Sleep Medicine (AASM), Vol. 17, No. 5 ( 2021-05), p. 897-908
    Type of Medium: Online Resource
    ISSN: 1550-9389 , 1550-9397
    URL: Article
    DOI: 10.5664/jcsm.9060
    Language: English
    Publisher: American Academy of Sleep Medicine (AASM)
    Publication Date: 2021
    detail.hit.zdb_id: 2210082-9
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  • 4
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    0739 Comparison Of Parent And Child Treatment Preferences For Obstructive Sleep Apnea
    Oxford University Press (OUP) ; 2019
    In:  Sleep Vol. 42, No. Supplement_1 ( 2019-04-13), p. A297-A297
    Details
    In: Sleep, Oxford University Press (OUP), Vol. 42, No. Supplement_1 ( 2019-04-13), p. A297-A297
    Type of Medium: Online Resource
    ISSN: 0161-8105 , 1550-9109
    URL: Article
    DOI: 10.1093/sleep/zsz067.737
    Language: English
    Publisher: Oxford University Press (OUP)
    Publication Date: 2019
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  • 5
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    605 Sleep problems are associated with behavioral problems and decreased quality of life in children with Fontan circulation
    Oxford University Press (OUP) ; 2021
    In:  Sleep Vol. 44, No. Supplement_2 ( 2021-05-03), p. A238-A238
    Details
    In: Sleep, Oxford University Press (OUP), Vol. 44, No. Supplement_2 ( 2021-05-03), p. A238-A238
    Abstract: Children with congenital heart disease who undergo a Fontan procedure are at higher risk of behavior and attention problems as well as reduced quality of life compared to age-matched peers. While sleep problems are associated with behavior and attention problems in children without Fontan circulation, this relationship has never been examined in children with Fontan circulation. We hypothesized that sleep problems in this population may increase the risk of behavior problems and also reduce health related quality of life (HRQOL). Methods We analyzed data from the Pediatric Heart Network Fontan cross-sectional study to evaluate associations between a parent-reported diagnosis of a sleep problem with reported behavioral concerns and HRQOL as measured by the child health questionnaire (CHQ) in 558 children with Fontan circulation. Analysis was performed using logistic regression or Wilcoxon sum rank test, as appropriate, with Bonferroni correction for multiple comparisons. Results Parent-reported sleep problems were present in 10% of participants. Sleep problems were associated with a 4.6x higher risk of attention problems, 10.2x higher risk of anxiety problems, 3.9x higher risk of behavioral problems, 9.5x higher risk of depression, 5.0x higher risk of developmental delay, 6.9x higher risk of learning problems and 2.2x higher risk of speech problems (p=0.04 for speech problems, p & lt;0.001 for all others). Parent report of a sleep problem was associated with decreased physical HRQOL (z-score -1.3 [interquartile range-2.2, -0.2] vs 0.0 [-0.8, 0.4] , p & lt;0.001) and psychosocial HRQOL (-0.9 [-1.9, 0.0] vs 0.0 [-0.8, 0.7] , p & lt;0.001) compared to children without a reported sleep problem. Report of a sleep problem was associated with significantly lower HRQOL across all subdomains of the CHQ (p & lt;0.05 for all subdomains). Conclusion Children with Fontan circulation with sleep problems have an increased risk of behavioral and developmental problems as well as reduced HRQOL. Better understanding of sleep problems is needed in children with Fontan circulation, as sleep disorders may represent a reversible cause of behavioral problems and decreased HRQOL in this population. Support (if any) Funding to DC from the American Heart Association, University of Arizona Health Sciences Center, and NIH-NHLBI. Fontan study data obtained from the Pediatric Heart Network.
    Type of Medium: Online Resource
    ISSN: 0161-8105 , 1550-9109
    URL: Article
    DOI: 10.1093/sleep/zsab072.603
    Language: English
    Publisher: Oxford University Press (OUP)
    Publication Date: 2021
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  • 6
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    0484 Trouble Sleeping Predicts Future Decreased Quality of Life in Young Children with Fontan Circulation
    Oxford University Press (OUP) ; 2022
    In:  Sleep Vol. 45, No. Supplement_1 ( 2022-05-25), p. A214-A214
    Details
    In: Sleep, Oxford University Press (OUP), Vol. 45, No. Supplement_1 ( 2022-05-25), p. A214-A214
    Abstract: Children with congenital heart disease who undergo a Fontan procedure are at higher risk of reduced health-related quality of life (HR-QOL) compared to age-matched peers. We have previously shown that current sleep disturbances are associated with decreased HR-QOL, but there is no existing longitudinal data on the relationship between sleep disturbance and HR-QOL in children with Fontan circulation. Methods We analyzed data from the Pediatric Heart Network Single Ventricle Reconstruction follow up study to evaluate associations between parent-reported trouble sleeping with HR-QOL as measured by the child health questionnaire (CHQ, measured at age 6 years) as well as the Pediatric Quality of Life questionnaire (PedsQL, measured at baseline as well as age 4, 5 and 6 years) in children with Fontan circulation. Presence of trouble sleeping was assessed at baseline and quality of life was assessed at baseline (age 3 years old) and annually for 3 years. Analysis was performed using the Wilcoxon sum rank test. Results 227 participants had data at baseline (age 3 years), and 196 participants completed HR-QOL measures at all time points. Parent-reported trouble sleeping was reported “often” or “almost always” in 11% of participants. Baseline trouble sleeping predicted decreased HR-QOL at all future time points, particularly psychosocial HR-QOL. Psychosocial HR-QOL as measured by the Peds QL was significantly lower at all time points in the group with trouble sleeping. At age 6 years, psychosocial HR-QOL remained significantly lower in the group with trouble sleeping at baseline on both the PedsQL (median score 78 [interquartile range 63, 90] vs 65 [58, 83] , p=0.03) and the CHQ (median t-score 54 [47, 59] vs 47 [42, 53] , p=0.002). Conclusion Trouble sleeping in children with Fontan circulation predicts future decreased HR-QOL. Better understanding of sleep problems is needed in children with Fontan circulation as sleep disorder treatment may lead to improved HR-QOL in this at-risk population. Support (If Any) Funding to DC from the American Heart Association and NIH-NHLBI. Single Ventricle Reconstruction study data obtained from the Pediatric Heart Network.
    Type of Medium: Online Resource
    ISSN: 0161-8105 , 1550-9109
    URL: Article
    DOI: 10.1093/sleep/zsac079.481
    Language: English
    Publisher: Oxford University Press (OUP)
    Publication Date: 2022
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  • 7
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    Abstract 14771: Obstructive Sleep Apnea is Associated With Cardiac Dysfunction in Children With Congenital Heart Disease
    Ovid Technologies (Wolters Kluwer Health) ; 2020
    In:  Circulation Vol. 142, No. Suppl_3 ( 2020-11-17)
    Details
    In: Circulation, Ovid Technologies (Wolters Kluwer Health), Vol. 142, No. Suppl_3 ( 2020-11-17)
    Abstract: Introduction: Obstructive sleep apnea (OSA) is associated with cardiac dysfunction in children without congenital heart disease (CHD). Children with CHD are at increased risk for OSA and may be susceptible to further cardiovascular consequences due to OSA but the extent and nature of such cardiovascular effects of OSA are unknown. Methods: Children (6-17 years old) with corrected CHD without current cyanosis or Down syndrome were recruited from pediatric cardiology clinic. Home sleep tests were done to determine the presence and severity of OSA. OSA was defined as an obstructive apnea hypopnea index (oAHI) ≥1. Mild OSA was defined as an oAHI of ≥1 to 〈 5 and moderate OSA was defined as an oAHI of ≥5 to 〈 10. Standard clinically indicated echocardiograms were performed in clinic. Echocardiographic findings were compared between children with CHD with and without comorbid OSA using t-tests, Wilcoxon-sign rank tests as well as linear or logistic regression as appropriate. Results: Thirty-two children had sleep study and echocardiographic data available. OSA was present in 18 children (56%). OSA was mild in 89% and moderate in 11% of cases. There were no significant differences in age, body mass index, CHD severity, gender or ethnicity between children with and without OSA. Children with OSA had larger height-indexed right ventricular end-diastolic diameter (RVDi) compared to those without OSA (median 1.35, 95% CI 1.09, 1.56 vs. 1.21, 95% CI 1.01, 1.57; p=0.04). Children with moderate OSA had a reduced left ventricular shortening fraction compared to both those with mild OSA and no OSA (30.0 ± 6.1% vs. 38.7 ± 4.4%; p=0.009 and 39.2 ± 3.6%; p=0.007, respectively). Children with moderate OSA had increased left ventricular end-systolic diameter compared to those with mild OSA and no OSA (3.4 ± 0.4 cm vs. 2.5 ± 0.4; p=0.007 and 2.4 ± 0.5; p=0.001, respectively). Children with an RVDi above the median were seven times more likely to have OSA than those with an RVDi below the median (odds ratio 6.9.; 95% CI 1.3, 35; p=0.02). Conclusions: OSA is associated with changes in cardiac morphology and reduced contractility in children with CHD. Additionally, the presence of right ventricular dilation may suggest the need for OSA evaluation in children with CHD.
    Type of Medium: Online Resource
    ISSN: 0009-7322 , 1524-4539
    URL: Article
    DOI: 10.1161/circ.142.suppl_3.14771
    Language: English
    Publisher: Ovid Technologies (Wolters Kluwer Health)
    Publication Date: 2020
    detail.hit.zdb_id: 1466401-X
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  • 8
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    Mother Knows Best? Comparing Child Report and Parent Report of Sleep Parameters With Polysomnography
    American Academy of Sleep Medicine (AASM) ; 2019
    In:  Journal of Clinical Sleep Medicine Vol. 15, No. 01 ( 2019-01-15), p. 111-117
    Details
    In: Journal of Clinical Sleep Medicine, American Academy of Sleep Medicine (AASM), Vol. 15, No. 01 ( 2019-01-15), p. 111-117
    Type of Medium: Online Resource
    ISSN: 1550-9389 , 1550-9397
    URL: Article
    DOI: 10.5664/jcsm.7582
    Language: English
    Publisher: American Academy of Sleep Medicine (AASM)
    Publication Date: 2019
    detail.hit.zdb_id: 2210082-9
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  • 9
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    The combination of atomoxetine and oxybutynin for the treatment of obstructive sleep apnea in children with Down syndrome
    American Academy of Sleep Medicine (AASM) ; 2023
    In:  Journal of Clinical Sleep Medicine
    Details
    In: Journal of Clinical Sleep Medicine, American Academy of Sleep Medicine (AASM)
    Type of Medium: Online Resource
    ISSN: 1550-9389 , 1550-9397
    URL: Article
    DOI: 10.5664/jcsm.10764
    Language: English
    Publisher: American Academy of Sleep Medicine (AASM)
    Publication Date: 2023
    detail.hit.zdb_id: 2210082-9
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  • 10
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    OSA and Neurocognitive Impairment in Children With Congenital Heart Disease
    Elsevier BV ; 2020
    In:  Chest Vol. 158, No. 3 ( 2020-09), p. 1208-1217
    Details
    In: Chest, Elsevier BV, Vol. 158, No. 3 ( 2020-09), p. 1208-1217
    Type of Medium: Online Resource
    ISSN: 0012-3692
    URL: Article
    DOI: 10.1016/j.chest.2020.03.021
    RVK:
    XA 36340
    Language: English
    Publisher: Elsevier BV
    Publication Date: 2020
    detail.hit.zdb_id: 2007244-2
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