Key Dates

Related Announcements

• March 7, 2024 - Notice of Participation of the National Institute on Aging in NOT-OD-24-044. See Notice NOT-AG-24-003
• May 7, 2020 - NIH Exploratory/Developmental Research Grant Program (Parent R21 Clinical Trial Not Allowed). See PA-20-195.  

Issued by

Office of The Director, National Institutes of Health (OD)

National Eye Institute (NEI)

Eunice Kennedy Shriver National Institute of Child Health and Human Development (NICHD)

National Institute on Aging (NIA) - March 7, 2024 Participation Added (NOT-AG-24-003)

Purpose

The last decade has seen an explosion of new technologies aimed at assessing and improving health. Examples include wearable devices, communication aids, robotics and e-textiles, just to name a few. During this period, there have also been enormous advances in technologies that were not created for health-related purposes, but that have potential applicability to health assessments and interventions, including mobile device applications (" apps" ) and social media platforms.

However, most of these technologies were originally developed for use in adults with typical cognitive and motor function. As a result, there is currently a relative paucity of valid and reliable technological tools for children and adults with intellectual and developmental disabilities (IDD) with a focus on Down syndrome (DS).

This Notice therefore invites applications specifically aimed at developing or building upon existing technological tools to improve diagnosis, assessments, interventions, management, and outcomes for infants, children, adolescents and adults with DS.

The INvestigation of Co-occurring conditions across the Lifespan to Understand Down syndromE (INCLUDE) Project was developed in response to Fiscal Year 2018, 2019, and 2020 Omnibus Appropriations Reports, which encouraged the NIH to expand its current efforts on DS and common co-occurring conditions also seen in the general population while increasing the pipeline of DS investigators. Information about projects that were funded from 2018 through 2020, as well as the INCLUDE Project Research Plan, is available on the INCLUDE Project website.

The purpose of this Notice of Special Interest (NOSI) is to support exploratory and developmental research project grant (R21) applications focused on digital technologies and/or mHealth that meet programmatic objectives for the INCLUDE Project. Sharing of resources and effective communication of outputs of appropriate interest to broader communities are a high priority of the INCLUDE Project. Applicants responding to this NOSI are strongly encouraged to describe plans for rapid sharing of data and results as well as innovative data analytics approaches (see Goal 3,NIH Strategic Plan For Data Science).

Applications in response to this NOSI should be aligned with the INCLUDE Project Research Plan, which consists of three components, two of which apply to this Notice:

• Component 2: Cohort Study to connect existing resources and expand to inclusion of individuals with DS
• Component 3: Inclusive clinical trials research for co-occurring conditions in individuals with DS

Projects that propose to recruit subjects with DS are encouraged to promote enrollment of research subjects in the DS patient registry supported by NIH, DS-Connect. For other data and biospecimens from human genetic or non-genetic studies, awardees are encouraged to use biorepositories designated by INCLUDE staff that meet requirements for broad sharing. An NIH resource describing Common Data Elements may be helpful during the planning phases of a project when considering ways to optimize data collection in order to facilitate broad data sharing. For those applications that generate clinical data, it is expected that the Data Management and Sharing Plan (DMS Plan) will include the INCLUDE Data Coordinating Center (DCC).

Background

The INvestigation of Co-occurring conditions across the Lifespan to Understand Down syndromE (INCLUDE) Project was developed in response to Fiscal Year 2018, 2019, and 2020 Omnibus Appropriations Reports, which encouraged the NIH to expand its current efforts on DS and common co-occurring conditions also seen in the general population while increasing the pipeline of DS investigators. Information about projects that were funded from 2018-2020, as well as the INCLUDE Project Research Plan, is available on the INCLUDE Project website.

Individuals with DS face significant and changing health challenges but have often been excluded from participation in research that could improve their health outcomes and quality of life. This population is understudied even though DS is the most common genetic cause of intellectual and developmental disabilities (IDD) and, in the past 25 years, the average lifespan has doubled from 30 to 60 years. In addition to intellectual disability, DS is associated with an increased prevalence of autism and epilepsy. About 75% of individuals with DS experience cognitive decline in a syndrome that resembles Alzheimer’s disease, but with onset a decade or two earlier than typical Alzheimer’s disease. Individuals with DS also have high rates of hearing loss, eye abnormalities, congenital heart defects, sleep apnea, pulmonary hypertension, gastrointestinal malformations, thyroid disease, leukemia, and other autoimmune or immune dysregulation disorders including celiac disease. However, people with DS infrequently develop solid tumors such as breast or prostate cancer. Despite multiple risk factors for coronary artery disease and high rates of obesity, sleep apnea, and type 1 diabetes, people with DS rarely develop atherosclerosis or have myocardial infarctions. Understanding this unique combination of risk and resiliencies will inform medical advances for individuals with DS and for individuals who do not have DS but who share these co-occurring conditions.

Scope

Applications responsive to this Notice will address tools and/or technologies and target populations of interest. Proposals must address one or more target populations of interest: infants, children, adolescents, and adults with DS.

Applications proposing tools and/or technologies may include, but are not limited to, home monitors, point-of-care diagnostic technologies, mobile devices, mobile device apps (including social media apps), and wearable sensors and monitors. They may also include tools that help share information between caregivers, or between families and clinicians, including tools that interface with electronic health record (EHR) platforms.

Technological areas of interest include, but are not limited to:

• Tools and technologies for assessing health and functional status among target populations. These may include:
  • tools and technologies that identify physical, mental health, or behavioral comorbidities among individuals with DS, such as seizures, sensory impairments, sleep impairments, or metabolic disorders
  • tools and technologies that aid in monitoring and promoting optimal quality of life, including physical well-being, mental health, social interactions, or nutritional status among individuals with DS
  • tools and technologies that support activities of daily living (ADLs) and independence
• Programs to create or integrate approved electronic consent/assent platforms or apps to advance remote participation in existing and/or new trials and clinical studies in DS
• Tools and technologies that identify robust and reliable clinical outcome measures or biomarkers or validate existing measures for use in treatment trials and assessments for those with DS
• Tools and technologies to deliver interventions to target populations. These may include:
  • tools and technologies that aim to improve compliance with interventions such as medications
  • tools and technologies that allow interventions to be delivered remotely
  • tools and technologies that aid caregivers in caring for individuals with DS
• Tests of the efficacy of technologies (i.e., digital, wearable technology) to promote healthy behaviors in individuals with DS across the lifespan
• Study the feasibility and validation of at-home diagnostic tools including actigraphy, home sleep apnea testing, and wearable technologies
• Development of apps and computer-based therapies that can be used in telehealth, home-based, and school-based treatment programs to improve intelligibility. These should be designed to accommodate different levels of cognitive or linguistic ability
• Self-support technologies and apps that can increase independence and reduce dependency on others in various areas of daily living

Specific examples of tools and technologies that could be applied to individuals with DS include but are not limited to the following:

• Validation of eye tracking technology to identify and monitor social gaze preferences in children with DS at risk for autism
• Development and/or validation of tools to detect cognitive decline or changes in behavior
• Wearable monitors, oximeters, actimetry sensors and other less disruptive technologies to assess obstructive sleep apnea (OSA) and other sleep disorders
• Using machine learning and /or artificial intelligence (ML/AI) to detect digital biomarkers of cognitive decline
• Devices that monitor physiologic parameters that may be valuable on their own or as proxy measures of other outcomes of interest; examples include heart rate monitors, multi-channel EEGs, instruments that measure metabolite levels, or devices that measure heart rate, blood pressure and skin conductance as proxy measures of anxiety
• Mobile device applications ( apps ) to aid communication in individuals with DS who also have language impairments, regression, or dementia
• Social media platforms or apps that can help individuals with DS connect to caregivers, health or medical services, or support communities
• E-textiles and clothing applications to improve the mobility and functioning of individuals with DS who also have motor impairments

Priorities by Institute and Center

The Eunice Kennedy Shriver National Institute of Child Health and Human Development (NICHD)

• Use of digital technologies and mHealth technology for networking support systems that integrate family-focused primary healthcare and preventive services (e.g., infant and childhood nutrition, immunizations)
• Use of digital technologies and mHealth technologies to enhance screening for co-morbidities associated with DS such as sleep apnea, obesity, and/or thyroid dysfunction and to develop community-based treatment paradigms for the co-occurring conditions associated with DS
• Use of digital technologies and mHealth technology to enhance prevention and treatment of injury and illness in children with DS
• Use of technology to respond to the needs of children with DS exposed to and affected by traumatic events such as a pandemic (such as COVID-19) or natural disaster
• Use of digital technologies and mHealth to support physical rehabilitation, health management, and community participation for people living with DS, in settings with limited resources and clinical support. This may include remote support of therapeutic exercise, assistive devices, periodic feedback on key clinical outcome measures, monitoring of progress, and interactive communication between therapists and the caregiver of the person with DS or the self-advocate
• Innovative and new digital technologies and mHealth solutions for improving transition of adolescents to adult healthcare providers by improving health literacy, enabling self-management and encouraging adherence to existing treatments among adolescents

National Eye Institute (NEI):

•  Digital technology and/or mobile health applications to diagnose, assess, and manage the potential ocular anterior segment manifestations of Down syndrome such as cataract, glaucoma, and refractive error.
•  Use and development of digital technology and mobile health applications for the potential treatment of upstream visual impairments including amblyopia.
•  Innovative applications that allow for remote screening methods to identify and measure visual impairments especially as they relate to individuals with Down syndrome.

Additional Guidance for INCLUDE Studies

To maximize comparisons across datasets or studies, and facilitate data integration and collaboration, applications submitted in response to this NOSI are strongly encouraged to incorporate the following standards and resources (where applicable):

• Projects that propose to recruit subjects with DS are encouraged to promote enrollment of research subjects in the DS patient registry supported by NIH,DS-Connect .
• Applicants are encouraged to ensure that data collected by the study conform to Findable, Accessible, Interoperable, and Reusable (FAIR) principles.
• NIH encourages researchers to explore the use of the HL7 FHIR (Fast Healthcare Interoperability Resources) standard to capture, integrate, and exchange clinical data for research purposes and to enhance capabilities to share research data (NOT-OD-19-122). The FHIR standard may be particularly useful in facilitating the flow of data with EHR-based datasets, tools, and applications.
• NIH encourages clinical research programs and researchers to adopt and use the standardized set of data classes, data elements, and associated vocabulary standards specified in the United States Core Data for Interoperability (USCDI) standards (NOT-OD-20-146), as they are applicable. Use of the USCDI can complement the FHIR standard and enable researchers to leverage structured EHR data for research and enable discovery.
• NIH encourages the use of data standards including common data elements, such as those available through the PhenX Toolkit (www.phenxtoolkit.org) and the NIH CDE repository (cde.nlm.nih.gov), terminologies and ontologies such as Mondo Disease Ontology (mondo.monarchinitiative.org), Human Phenotype Ontology (hpo.jax.org), and common data models such as the Observational Medical Outcomes Partnership (OMOP; ohdsi.org).

Application and Submission Information

This notice applies to due dates on or after February 16, 2024 and subsequent receipt dates through February 14, 2025. 

Submit applications for this initiative using the following notice of funding opportunity (NOFO) or any reissues of this announcement through the expiration date of this notice.

• PA-20-195 NIH Exploratory/Developmental Research Grant Program (Parent R21 Clinical Trial Not Allowed)

All instructions in the SF424 (R&R) Application Guide and the notice of funding opportunity used for submission must be followed, with the following additions:

• For funding consideration, applicants must include “NOT-OD-24-044” (without quotation marks) in the Agency Routing Identifier field (box 4B) of the SF424 R&R form. Applications without this information in box 4B will not be considered for this initiative.

Applications nonresponsive to terms of this NOSI will not be considered for the NOSI initiative.

Inquiries

Please direct all inquiries to the contacts in Section VII of the listed notice of funding opportunity with the following additions/substitutions:

Scientific/Research Contact(s)

Sujata Bardhan, MS, PhD
Eunice Kennedy Shriver National Institute of Child Health and Human Development (NICHD)
Telephone: 301-435-0471
Email: sujata.bardhan@nih.gov

Peer Review Contact(s)

Examine your eRA Commons account for review assignment and contact information (information appears two weeks after the submission due date).

Financial/Grants Management Contact(s)

Margaret Young
Eunice Kennedy Shriver National Institute of Child Health and Human Development (NICHD)
Telephone: 301-642-4552
Email: margaret.young@nih.gov