Saturday, November 23, 2024 11/23/2024

Positive Airway Pressure For The Treatment Of The Obstructive Sleep Apnea Syndrome In Children With Down Syndrome

Award Number: R33HL151253
ORGANIZATION: NATIONAL HEART, LUNG, & BLOOD INSTITUTE
OPDIV: NIH
AWARD CLASS: DISCRETIONARY
AWARD ACTIVITY TYPE: SCIENTIFIC/HEALTH RESEARCH (INCLUDES SURVEYS)

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Abstract Individuals with Down syndrome (DS) are predisposed to OSAS due to craniofacial features (midface hypoplasia, glossoptosis) and studies have shown that the prevalence of OSAS in this population is markedly increased compared to that of typically developing children. Adenotonsillectomy (AT) is considered first-line treatment for childhood OSAS. However, OSAS resolves in only a portion of children with DS after AT. In fact, many children with DS are referred for positive airway pressure (PAP) therapy initiation due to persistent OSAS after AT, and PAP appears to be an important feature of the experience of living with DS. PAP has been shown to be highly effective at treating OSAS and improve OSAS-associated neurobehavioral symptoms, such as quality of life, behavior, mood, daytime sleepiness and school performance. However, PAP as a treatment for OSAS has not been well-studied in children with DS. Therefore, we propose to leverage the HEalthy SLeeP for Children with Down Syndrome (HELP-DS, U01HL125295-S1 and U01HL123507-S1) infrastructure and conduct in two HELP-DS sites (Philadelphia and Cincinnati) plus the University of Miami, a randomized controlled trial to test a 6-month intensive behavioral intervention (INT) to improve PAP adherence vs standard clinical care (CON). Participants with DS and OSAS, aged 6-17.9 years, referred to PAP initiation for the treatment of OSAS will be included. They will undergo standardized evaluations of quality of life, behavior, attention, and family-relevant outcomes, PAP adherence, and health care utilization at baseline, 6, and 12 months. This rigorous design and comprehensive study will resolve existing uncertainties on initial management approaches for children with DS and OSAS treated with PAP by addressing critical issues: a) determine the efficacy of INT vs CON in promoting PAP adherence, b) elucidate which factors mediate or moderate adherence to PAP in children with DS and OSAS, c) determine the effect of PAP use on neurobehavioral and family-relevant outcomes, and quality of life.


Issue Date FY	Funding FY	Legal Entity Name	Legal Entity Address	Legal Entity City	Legal Entity State	Legal Entity Zip Code	Legal Entity COUNTY	Legal Entity COUNTRY	Assistance Listing	Award Code	Budget Year	Action Date	Action Type	Action Amount

Issue Date FY: 2025 ( Subtotal = $0 )
2025	2023	UNIVERSITY OF MIAMI	1320 S DIXIE HWY STE 1200	CORAL GABLES	FL	33146	MIAMI-DADE	USA	National Center on Sleep Disorders Research	004	5	11/21/2024	CHANGE OF GRANTEE / TRAINING INSTITUTION / AWARDING INSTITUTION	$0
2025	2023	UNIVERSITY OF MIAMI	1320 S DIXIE HWY STE 1200	CORAL GABLES	FL	33146	MIAMI-DADE	USA	National Center on Sleep Disorders Research	003	5	11/4/2024	CHANGE OF GRANTEE / TRAINING INSTITUTION / AWARDING INSTITUTION	$1,054,272
2025	2022	THE CHILDREN'S HOSPITAL OF PHILADELPHIA	3401 CIVIC CENTER BLVD	PHILADELPHIA	PA	19104	PHILADELPHIA	USA	National Center on Sleep Disorders Research	001	4	11/4/2024	NON-COMPETING CONTINUATION	-$1,029,494
2025	2021	THE CHILDREN'S HOSPITAL OF PHILADELPHIA	3401 CIVIC CENTER BLVD	PHILADELPHIA	PA	19104	PHILADELPHIA	USA	National Center on Sleep Disorders Research	002	3	11/4/2024	SUPPLEMENT FOR EXPANSION	-$1,207
2025	2021	THE CHILDREN'S HOSPITAL OF PHILADELPHIA	3401 CIVIC CENTER BLVD	PHILADELPHIA	PA	19104	PHILADELPHIA	USA	National Center on Sleep Disorders Research	000	3	11/4/2024	EXTENSION WITH OR WITHOUT FUNDS	-$23,571
														Subtotal = $0

Issue Date FY: 2024 ( Subtotal = $0 )
2024	2023	UNIVERSITY OF MIAMI	1320 S DIXIE HWY STE 1200	CORAL GABLES	FL	33146	MIAMI-DADE	USA	National Center on Sleep Disorders Research	001	5	2/3/2024	SUPPLEMENT FOR EXPANSION	$0
2024	2023	UNIVERSITY OF MIAMI	1320 S DIXIE HWY STE 1200	CORAL GABLES	FL	33146	MIAMI-DADE	USA	National Center on Sleep Disorders Research	000	5	12/21/2023	CHANGE OF GRANTEE / TRAINING INSTITUTION / AWARDING INSTITUTION	$0
														Subtotal = $0

Issue Date FY: 2023 ( Subtotal = $986,540 )
2023	2023	UNIVERSITY OF MIAMI	1400 NW 10TH AVE	MIAMI	FL	33136	MIAMI-DADE	USA	National Center on Sleep Disorders Research	004	5	9/6/2023	SUPPLEMENT FOR EXPANSION	$0
2023	2023	UNIVERSITY OF MIAMI	1400 NW 10TH AVE	MIAMI	FL	33136	MIAMI-DADE	USA	National Center on Sleep Disorders Research	003	5	8/29/2023	SUPPLEMENT FOR EXPANSION	$63,939
2023	2023	UNIVERSITY OF MIAMI	1400 NW 10TH AVE	MIAMI	FL	33136	MIAMI-DADE	USA	National Center on Sleep Disorders Research	001	5	8/25/2023	CHANGE OF GRANTEE / TRAINING INSTITUTION / AWARDING INSTITUTION	$922,601
2023	2022	CHILDREN'S HOSPITAL OF PHILADELPHIA, THE	3401 CIVIC CENTER BLVD	PHILADELPHIA	PA	19104	PHILADELPHIA	USA	National Center on Sleep Disorders Research	000	4	8/24/2023	NON-COMPETING CONTINUATION	$0
2023	2021	CHILDREN'S HOSPITAL OF PHILADELPHIA, THE	3401 CIVIC CENTER BLVD	PHILADELPHIA	PA	19104	PHILADELPHIA	USA	National Center on Sleep Disorders Research	002	3	8/28/2023	SUPPLEMENT FOR EXPANSION	$0
														Subtotal = $986,540

Issue Date FY: 2022 ( Subtotal = $1,398,390 )
2022	2022	CHILDREN'S HOSPITAL OF PHILADELPHIA, THE	3401 CIVIC CENTER BLVD	PHILADELPHIA	PA	19104	PHILADELPHIA	USA	National Center on Sleep Disorders Research	002	4	8/16/2022	SUPPLEMENT FOR EXPANSION	$59,990
2022	2022	CHILDREN'S HOSPITAL OF PHILADELPHIA, THE	3401 CIVIC CENTER BLVD	PHILADELPHIA	PA	19104	PHILADELPHIA	USA	National Center on Sleep Disorders Research	001	4	8/12/2022	NON-COMPETING CONTINUATION	$1,029,494
2022	2022	CHILDREN'S HOSPITAL OF PHILADELPHIA, THE	3401 CIVIC CENTER BLVD	PHILADELPHIA	PA	19104	PHILADELPHIA	USA	National Center on Sleep Disorders Research	003	4	8/17/2022	SUPPLEMENT FOR EXPANSION	-$59,990
2022	2022	CHILDREN'S HOSPITAL OF PHILADELPHIA, THE	3401 CIVIC CENTER BLVD	PHILADELPHIA	PA	19104	PHILADELPHIA	USA	National Center on Sleep Disorders Research	004	4	9/26/2022	SUPPLEMENT FOR EXPANSION	$0
2022	2021	CHILDREN'S HOSPITAL OF PHILADELPHIA, THE	3401 CIVIC CENTER BLVD	PHILADELPHIA	PA	19104	PHILADELPHIA	USA	National Center on Sleep Disorders Research	000	3	5/25/2022	EXTENSION WITH OR WITHOUT FUNDS	$368,896
														Subtotal = $1,398,390

Issue Date FY: 2021 ( Subtotal = $1,026,373 )
2021	2021	CHILDREN'S HOSPITAL OF PHILADELPHIA, THE	3401 CIVIC CENTER BLVD	PHILADELPHIA	PA	19104	PHILADELPHIA	USA	National Center on Sleep Disorders Research	000	3	8/14/2021	EXTENSION WITH OR WITHOUT FUNDS	$976,385
2021	2021	CHILDREN'S HOSPITAL OF PHILADELPHIA, THE	3401 CIVIC CENTER BLVD	PHILADELPHIA	PA	19104	PHILADELPHIA	USA	National Center on Sleep Disorders Research	001	3	9/24/2021	SUPPLEMENT FOR EXPANSION	$49,988
														Subtotal = $1,026,373

Grand Total All Awards = $3,411,303

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Positive Airway Pressure For The Treatment Of The Obstructive Sleep Apnea Syndrome In Children With Down Syndrome

Award Number: R33HL151253

ORGANIZATION: NATIONAL HEART, LUNG, & BLOOD INSTITUTE

OPDIV: NIH

AWARD CLASS: DISCRETIONARY

AWARD ACTIVITY TYPE: SCIENTIFIC/HEALTH RESEARCH (INCLUDES SURVEYS)

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