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Feasibility and design of a novel smartphone app to deliver blood pressure-lowering inspiratory muscle strength training

Award Information
Agency: Department of Health and Human Services
Branch: National Institutes of Health
Contract: 1R41HL167375-01A1
Agency Tracking Number: R41HL167375
Amount: $275,764.00
Phase: Phase I
Program: STTR
Solicitation Topic Code: NHLBI
Solicitation Number: PA22-178
Solicitation Year: 2022
Award Year: 2023
Award Start Date (Proposal Award Date): 2023-05-23
Award End Date (Contract End Date): 2024-04-30
Small Business Information
1667 Cole Blvd, Ste 220
Golden, CO 80401-3313
United States
DUNS: 117936042
HUBZone Owned: No
Woman Owned: Yes
Socially and Economically Disadvantaged: No
Principal Investigator
 (303) 492-5305
Business Contact
Phone: (303) 565-4330
Research Institution
BOULDER, CO 80303-1058
United States

 Nonprofit College or University

PROJECT SUMMARYHigh blood pressure (BP), particularly high systolic BP (SBP), is the major modifiable risk factor for
cardiovascular diseases (CVD) and related conditions. Indeed, over 50% of all adults have above-normal
SBP (≥120 mmHg), placing them at increased disease risk. In addition, these adults face ~$2000/year in
excess medical expenses compared to their peers with normal BP. Rates of BP control in the United States
are worsening, predicting a new epidemic of disorders driven by above-normal SBP, and an increasing
financial burden for those affected, unless innovative and affordable therapies with clinical efficacy can be
adopted by, and translated to, this at-risk group.High-resistance inspiratory muscle strength training (IMST) is a novel lifestyle intervention involving
repeated inhalations against resistance with a hand-held device. In a randomized, double-blind, sham-
controlled, R21-funded study in adults with above-normal SBP (n=36), we found that IMST (30 breaths/day [~5
min/day] at 75% maximal inspiratory pressure [PIMAX], 6 days/week for 6 weeks) had excellent adherence
(94% of prescribed training sessions completed), increased inspiratory muscle strength (~20% increase in
PIMAX) and lowered SBP by 9 mmHg compared to low-resistance sham training – thus establishing the clinical
efficacy of high-resistance IMST. Importantly, this 9-mmHg reduction in SBP compares favorably to time-
intensive lifestyle strategies (e.g., aerobic exercise) and pharmacotherapy, without the side effects associated
with medication. However, this trial was performed in the research clinic. Therefore, the next step in the overall
translation of IMST for improving public health is to establish a vehicle to disseminate IMST instruction and
promote intervention adherence by utilizing digital health technologies and creating a smartphone app.In this Phase I STTR application, we propose to begin the process of developing a smartphone app for
commercialization that independently guides users through an IMST intervention for lowering SBP and
reducing disease risk and the associated financial burden. This will be accomplished through 3 specific aims:
Aim 1: Conduct iterative focus groups with adults who have above-normal SBP to collect potential user
information for IMST smartphone app needs and preferences;
Aim 2: Finalize the conceptual model and develop planned app components including printed wireframes,
storyboards, and clickable wireframes; and
Aim 3: Conduct beta testing on the clickable wireframes and finalize app design.
Successful completion of the above aims will position us to develop the fully programmed high-resistance
IMST smartphone app and apply for Phase II STTR funding to conduct a randomized clinical trial assessing
the effectiveness of at-home IMST with the app for lowering SBP. Ultimately, our app will fill an unmet need in
the marketplace by delivering an effective, adherable, cost-saving, BP-lowering intervention.

* Information listed above is at the time of submission. *

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