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| ID | Type | Description | Link |
|---|---|---|---|
| R61HL151253-01 | U.S. NIH Grant/Contract | View source |
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| Name | Class |
|---|---|
| National Institutes of Health (NIH) | NIH |
| National Heart, Lung, and Blood Institute (NHLBI) | NIH |
| University of Pennsylvania | OTHER |
| Children's Hospital Medical Center, Cincinnati |
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To identify the perceptions, beliefs, and family-relevant outcomes regarding the treatment of obstructive sleep apnea syndrome (OSAS) with positive airway pressure (PAP) in children with Down's Syndrome (DS).
This is a multi-center outpatient study to be performed at two clinical sites: Children's Hospital of Philadelphia and Cincinnati Children's Hospital. Forty Caregivers of children with DS and OSAS treated with PAP and their children will be enrolled. The study comprises one 30-minute open-ended semi-structured interview per caregiver. The duration of the interview is approximate. It will last up to 30 minutes as some families may want to include more details.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Participants treated with PAP | Other | This is a qualitative study for participants with Down Syndrome who use PAP to treat obstructive sleep apnea syndrome. |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Open-ended semi-structured interviews | Behavioral | Semi-structured interviews will explore such key constructs as knowledge/belief about OSAS and PAP therapy, routines and resources that promote or limit PAP use, barriers, self-efficacy, and communication and attitudes about PAP. The interviews will be performed with the parent and that they will be audio-recorded. |
| Measure | Description | Time Frame |
|---|---|---|
| Number of Participants Who Completed Interviews Regarding Positive Airway Pressure (PAP) Acceptability | PAP feasibility will be measured by completion of semi-structured interviews to explore attitudes about PAP therapy in youth with Down Syndrome and Obstructive Sleep Apnea Syndrome. | one day |
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Inclusion Criteria -- Patients
Inclusion Criteria -- Caregivers
Exclusion Criteria -- Patients
Exclusion Criteria -- Caregivers
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| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| The Children's Hospital of Philadelphia | Philadelphia | Pennsylvania | 19104 | United States |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 23885965 | Background | Presson AP, Partyka G, Jensen KM, Devine OJ, Rasmussen SA, McCabe LL, McCabe ER. Current estimate of Down Syndrome population prevalence in the United States. J Pediatr. 2013 Oct;163(4):1163-8. doi: 10.1016/j.jpeds.2013.06.013. Epub 2013 Jul 23. | |
| 24265125 | Background | Mai CT, Kucik JE, Isenburg J, Feldkamp ML, Marengo LK, Bugenske EM, Thorpe PG, Jackson JM, Correa A, Rickard R, Alverson CJ, Kirby RS; National Birth Defects Prevention Network. Selected birth defects data from population-based birth defects surveillance programs in the United States, 2006 to 2010: featuring trisomy conditions. Birth Defects Res A Clin Mol Teratol. 2013 Nov;97(11):709-25. doi: 10.1002/bdra.23198. No abstract available. |
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| ID | Title | Description |
|---|---|---|
| FG000 | Interview Completion | The number of participants who completed the interview process. |
| Title | Milestones | Reasons Not Completed | ||||||||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Overall Study |
|
|
The number of participants who completed the interview process from both study sites.
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| ID | Title | Description |
|---|---|---|
| BG000 | Interview Completion | The number of participants who completed the interview process. |
| Units | Counts |
|---|---|
| Participants |
|
| Title | Description | Population Description | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Denominator Units Selected | Denominators | Classes |
|---|---|---|---|---|---|---|---|---|---|
| Age, Customized | Mean |
| Type | Title | Description | Population Description | Reporting Status | Anticipated Posting Date | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Time Frame | Units Analyzed | Denominator Units Selected | Arm/Group Information | Denominators | Classes | Analyses | ||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Primary | Number of Participants Who Completed Interviews Regarding Positive Airway Pressure (PAP) Acceptability | PAP feasibility will be measured by completion of semi-structured interviews to explore attitudes about PAP therapy in youth with Down Syndrome and Obstructive Sleep Apnea Syndrome. | Posted | Count of Participants | Participants | one day |
|
|
Up to one hour
There were no adverse events reported as this is a one-time telephone interview study.
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| ID | Title | Description | Deaths (Affected) | Deaths (At Risk) | Serious Events (Affected) | Serious Events (At Risk) | Other Events (Affected) | Other Events (At Risk) |
|---|---|---|---|---|---|---|---|---|
| EG000 | Interview Completion | The number of participants who completed the interview process. |
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| Title | Organization | Phone | Extension | |
|---|---|---|---|---|
| Ignacio Tapia, MD | Children's Hospital of Philadelphia | (267) 426-5842 | tapia@chop.edu |
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| Type | Includes Protocol | Includes SAP | Includes ICF | Document Label | Document Date | Document Uploaded Date | Document File Name |
|---|---|---|---|---|---|---|---|
| Prot_SAP | Yes | Yes | No | Study Protocol and Statistical Analysis Plan | Feb 20, 2020 | Feb 6, 2023 | Prot_SAP_000.pdf |
| ICF | No | No | Yes | Informed Consent Form | Aug 2, 2019 | Nov 1, 2022 | ICF_001.pdf |
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| ID | Term |
|---|---|
| D004314 | Down Syndrome |
| D020181 | Sleep Apnea, Obstructive |
| ID | Term |
|---|---|
| D008607 | Intellectual Disability |
| D019954 | Neurobehavioral Manifestations |
| D009461 | Neurologic Manifestations |
| D009422 | Nervous System Diseases |
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| OTHER |
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|
| 25822844 | Background | de Graaf G, Buckley F, Skotko BG. Estimates of the live births, natural losses, and elective terminations with Down syndrome in the United States. Am J Med Genet A. 2015 Apr;167A(4):756-67. doi: 10.1002/ajmg.a.37001. |
| 17910090 | Background | Sherman SL, Allen EG, Bean LH, Freeman SB. Epidemiology of Down syndrome. Ment Retard Dev Disabil Res Rev. 2007;13(3):221-7. doi: 10.1002/mrdd.20157. |
| 21788214 | Background | Bull MJ; Committee on Genetics. Health supervision for children with Down syndrome. Pediatrics. 2011 Aug;128(2):393-406. doi: 10.1542/peds.2011-1605. Epub 2011 Jul 25. |
| 7931873 | Background | Marcus CL, Carroll JL, Koerner CB, Hamer A, Lutz J, Loughlin GM. Determinants of growth in children with the obstructive sleep apnea syndrome. J Pediatr. 1994 Oct;125(4):556-62. doi: 10.1016/s0022-3476(94)70007-9. |
| 9563725 | Background | Marcus CL, Greene MG, Carroll JL. Blood pressure in children with obstructive sleep apnea. Am J Respir Crit Care Med. 1998 Apr;157(4 Pt 1):1098-103. doi: 10.1164/ajrccm.157.4.9704080. |
| 12016102 | Background | Amin RS, Kimball TR, Bean JA, Jeffries JL, Willging JP, Cotton RT, Witt SA, Glascock BJ, Daniels SR. Left ventricular hypertrophy and abnormal ventricular geometry in children and adolescents with obstructive sleep apnea. Am J Respir Crit Care Med. 2002 May 15;165(10):1395-9. doi: 10.1164/rccm.2105118. |
| 14764433 | Background | Amin RS, Carroll JL, Jeffries JL, Grone C, Bean JA, Chini B, Bokulic R, Daniels SR. Twenty-four-hour ambulatory blood pressure in children with sleep-disordered breathing. Am J Respir Crit Care Med. 2004 Apr 15;169(8):950-6. doi: 10.1164/rccm.200309-1305OC. Epub 2004 Feb 5. |
| 10960692 | Background | Miman MC, Kirazli T, Ozyurek R. Doppler echocardiography in adenotonsillar hypertrophy. Int J Pediatr Otorhinolaryngol. 2000 Aug 11;54(1):21-6. doi: 10.1016/s0165-5876(00)00338-4. |
| 2836784 | Background | Tal A, Leiberman A, Margulis G, Sofer S. Ventricular dysfunction in children with obstructive sleep apnea: radionuclide assessment. Pediatr Pulmonol. 1988;4(3):139-43. doi: 10.1002/ppul.1950040304. |
| 20956420 | Background | Gozal D, Kheirandish-Gozal L, Bhattacharjee R, Spruyt K. Neurocognitive and endothelial dysfunction in children with obstructive sleep apnea. Pediatrics. 2010 Nov;126(5):e1161-7. doi: 10.1542/peds.2010-0688. Epub 2010 Oct 18. |
| 20203242 | Background | Kheirandish-Gozal L, Bhattacharjee R, Kim J, Clair HB, Gozal D. Endothelial progenitor cells and vascular dysfunction in children with obstructive sleep apnea. Am J Respir Crit Care Med. 2010 Jul 1;182(1):92-7. doi: 10.1164/rccm.200912-1845OC. Epub 2010 Mar 4. |
| 15684300 | Background | Montgomery-Downs HE, Crabtree VM, Gozal D. Cognition, sleep and respiration in at-risk children treated for obstructive sleep apnoea. Eur Respir J. 2005 Feb;25(2):336-42. doi: 10.1183/09031936.05.00082904. |
| 16585288 | Background | Chervin RD, Ruzicka DL, Giordani BJ, Weatherly RA, Dillon JE, Hodges EK, Marcus CL, Guire KE. Sleep-disordered breathing, behavior, and cognition in children before and after adenotonsillectomy. Pediatrics. 2006 Apr;117(4):e769-78. doi: 10.1542/peds.2005-1837. |
| 22323303 | Background | Marcus CL, Radcliffe J, Konstantinopoulou S, Beck SE, Cornaglia MA, Traylor J, DiFeo N, Karamessinis LR, Gallagher PR, Meltzer LJ. Effects of positive airway pressure therapy on neurobehavioral outcomes in children with obstructive sleep apnea. Am J Respir Crit Care Med. 2012 May 1;185(9):998-1003. doi: 10.1164/rccm.201112-2167OC. Epub 2012 Feb 9. |
| 15175097 | Background | O'Brien LM, Mervis CB, Holbrook CR, Bruner JL, Smith NH, McNally N, McClimment MC, Gozal D. Neurobehavioral correlates of sleep-disordered breathing in children. J Sleep Res. 2004 Jun;13(2):165-72. doi: 10.1111/j.1365-2869.2004.00395.x. |
| 9738185 | Background | Gozal D. Sleep-disordered breathing and school performance in children. Pediatrics. 1998 Sep;102(3 Pt 1):616-20. doi: 10.1542/peds.102.3.616. |
| 23692173 | Background | Marcus CL, Moore RH, Rosen CL, Giordani B, Garetz SL, Taylor HG, Mitchell RB, Amin R, Katz ES, Arens R, Paruthi S, Muzumdar H, Gozal D, Thomas NH, Ware J, Beebe D, Snyder K, Elden L, Sprecher RC, Willging P, Jones D, Bent JP, Hoban T, Chervin RD, Ellenberg SS, Redline S; Childhood Adenotonsillectomy Trial (CHAT). A randomized trial of adenotonsillectomy for childhood sleep apnea. N Engl J Med. 2013 Jun 20;368(25):2366-76. doi: 10.1056/NEJMoa1215881. Epub 2013 May 21. |
| 26651430 | Background | Glasson EJ, Jacques A, Wong K, Bourke J, Leonard H. Improved Survival in Down Syndrome over the Last 60 Years and the Impact of Perinatal Factors in Recent Decades. J Pediatr. 2016 Feb;169:214-20.e1. doi: 10.1016/j.jpeds.2015.10.083. Epub 2015 Dec 2. |
| 23248222 | Background | Kucik JE, Shin M, Siffel C, Marengo L, Correa A; Congenital Anomaly Multistate Prevalence and Survival Collaborative. Trends in survival among children with Down syndrome in 10 regions of the United States. Pediatrics. 2013 Jan;131(1):e27-36. doi: 10.1542/peds.2012-1616. Epub 2012 Dec 17. |
| 6476635 | Background | Rajagopal KR, Abbrecht PH, Derderian SS, Pickett C, Hofeldt F, Tellis CJ, Zwillich CW. Obstructive sleep apnea in hypothyroidism. Ann Intern Med. 1984 Oct;101(4):491-4. doi: 10.7326/0003-4819-101-4-491. |
| 1836718 | Background | Stebbens VA, Dennis J, Samuels MP, Croft CB, Southall DP. Sleep related upper airway obstruction in a cohort with Down's syndrome. Arch Dis Child. 1991 Nov;66(11):1333-8. doi: 10.1136/adc.66.11.1333. |
| 1829151 | Background | Marcus CL, Keens TG, Bautista DB, von Pechmann WS, Ward SL. Obstructive sleep apnea in children with Down syndrome. Pediatrics. 1991 Jul;88(1):132-9. |
| 14746382 | Background | de Miguel-Diez J, Villa-Asensi JR, Alvarez-Sala JL. Prevalence of sleep-disordered breathing in children with Down syndrome: polygraphic findings in 108 children. Sleep. 2003 Dec 15;26(8):1006-9. doi: 10.1093/sleep/26.8.1006. |
| 10228121 | Background | Redline S, Tishler PV, Schluchter M, Aylor J, Clark K, Graham G. Risk factors for sleep-disordered breathing in children. Associations with obesity, race, and respiratory problems. Am J Respir Crit Care Med. 1999 May;159(5 Pt 1):1527-32. doi: 10.1164/ajrccm.159.5.9809079. |
| 22926176 | Background | 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. |
| 28055122 | Background | Farhood Z, Isley JW, Ong AA, Nguyen SA, Camilon TJ, LaRosa AC, White DR. Adenotonsillectomy outcomes in patients with Down syndrome and obstructive sleep apnea. Laryngoscope. 2017 Jun;127(6):1465-1470. doi: 10.1002/lary.26398. Epub 2017 Jan 5. |
| 27092702 | Background | Hawkins SM, Jensen EL, Simon SL, Friedman NR. Correlates of Pediatric CPAP Adherence. J Clin Sleep Med. 2016 Jun 15;12(6):879-84. doi: 10.5664/jcsm.5892. |
| 22926173 | Background | Marcus CL, Brooks LJ, Draper KA, Gozal D, Halbower AC, Jones J, Schechter MS, Sheldon SH, Spruyt K, Ward SD, Lehmann C, Shiffman RN; American Academy of Pediatrics. Diagnosis and management of childhood obstructive sleep apnea syndrome. Pediatrics. 2012 Sep;130(3):576-84. doi: 10.1542/peds.2012-1671. Epub 2012 Aug 27. |
| 22334807 | Background | Marcus CL, Beck SE, Traylor J, Cornaglia MA, Meltzer LJ, DiFeo N, Karamessinis LR, Samuel J, Falvo J, DiMaria M, Gallagher PR, Beris H, Menello MK. Randomized, double-blind clinical trial of two different modes of positive airway pressure therapy on adherence and efficacy in children. J Clin Sleep Med. 2012 Feb 15;8(1):37-42. doi: 10.5664/jcsm.1656. |
| 30581976 | Background | Strydom A, Coppus A, Blesa R, Danek A, Fortea J, Hardy J, Levin J, Nuebling G, Rebillat AS, Ritchie C, van Duijn C, Zaman S, Zetterberg H. Alzheimer's disease in Down syndrome: An overlooked population for prevention trials. Alzheimers Dement (N Y). 2018 Dec 13;4:703-713. doi: 10.1016/j.trci.2018.10.006. eCollection 2018. |
| 21652236 | Background | Sawyer AM, Gooneratne NS, Marcus CL, Ofer D, Richards KC, Weaver TE. A systematic review of CPAP adherence across age groups: clinical and empiric insights for developing CPAP adherence interventions. Sleep Med Rev. 2011 Dec;15(6):343-56. doi: 10.1016/j.smrv.2011.01.003. Epub 2011 Jun 8. |
| 16774155 | Background | O'Donnell AR, Bjornson CL, Bohn SG, Kirk VG. Compliance rates in children using noninvasive continuous positive airway pressure. Sleep. 2006 May;29(5):651-8. |
| 28410811 | Background | Castro-Codesal ML, Dehaan K, Featherstone R, Bedi PK, Martinez Carrasco C, Katz SL, Chan EY, Bendiak GN, Almeida FR, Olmstead DL, Young R, Woolf V, Waters KA, Sullivan C, Hartling L, MacLean JE. Long-term non-invasive ventilation therapies in children: A scoping review. Sleep Med Rev. 2018 Feb;37:148-158. doi: 10.1016/j.smrv.2017.02.005. Epub 2017 Mar 2. |
| 21601219 | Background | Nixon GM, Mihai R, Verginis N, Davey MJ. Patterns of continuous positive airway pressure adherence during the first 3 months of treatment in children. J Pediatr. 2011 Nov;159(5):802-7. doi: 10.1016/j.jpeds.2011.04.013. Epub 2011 May 20. |
| 7608817 | Background | Marcus CL, Ward SL, Mallory GB, Rosen CL, Beckerman RC, Weese-Mayer DE, Brouillette RT, Trang HT, Brooks LJ. Use of nasal continuous positive airway pressure as treatment of childhood obstructive sleep apnea. J Pediatr. 1995 Jul;127(1):88-94. doi: 10.1016/s0022-3476(95)70262-8. |
| 31138379 | Background | Kang EK, Xanthopoulos MS, Kim JY, Arevalo C, Shults J, Beck SE, Marcus CL, Tapia IE. Adherence to Positive Airway Pressure for the Treatment of Obstructive Sleep Apnea in Children With Developmental Disabilities. J Clin Sleep Med. 2019 Jun 15;15(6):915-921. doi: 10.5664/jcsm.7850. |
| Background | Boeije H. A purposeful approach to the constant comparative method in the analysis of qualitative interviews. Quality and Quantity. 2002;36:391-409 |
| 37196396 | Derived | Xanthopoulos MS, Nelson MN, Eriksen W, Barg FK, Byars KC, Ishman SL, Esbensen AJ, Meinzen-Derr J, Heubi CH, Gurbani NS, Bradford R, Hicks S, Tapia IE. Caregiver experiences helping children with Down syndrome use positive airway pressure to treat obstructive sleep apnea. Sleep Med. 2023 Jul;107:179-186. doi: 10.1016/j.sleep.2023.04.022. Epub 2023 Apr 28. |
| years |
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| Sex: Female, Male | Count of Participants | Participants |
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| Ethnicity (NIH/OMB) | Count of Participants | Participants |
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| Race (NIH/OMB) | Count of Participants | Participants |
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| Region of Enrollment | Number | participants |
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| 0 |
| 41 |
| 0 |
| 41 |
| 0 |
| 41 |
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| D000015 | Abnormalities, Multiple |
| D000013 | Congenital Abnormalities |
| D009358 | Congenital, Hereditary, and Neonatal Diseases and Abnormalities |
| D025063 | Chromosome Disorders |
| D030342 | Genetic Diseases, Inborn |
| D012891 | Sleep Apnea Syndromes |
| D001049 | Apnea |
| D012120 | Respiration Disorders |
| D012140 | Respiratory Tract Diseases |
| D020919 | Sleep Disorders, Intrinsic |
| D020920 | Dyssomnias |
| D012893 | Sleep Wake Disorders |