# Prapela™ SVS: A cost-effective stochastic vibrotactile stimulation device toimprove the clinical course of infants with neonatal abstinence syndrome.

> **NIH NIH R44** · PRAPELA, INC. · 2021 · $1,330,596

## Abstract

Project Summary/Abstract
Maternal use and addiction to opioids has resulted in an unprecedented rise in drug withdrawal complications in
newborns known as neonatal opioid withdrawal syndrome (NOWS), also referred to as neonatal abstinence
syndrome (NAS). Between 2004 and 2016, NOWS admissions increased more than fourfold with an average
hospital stay nearly 3.2 times longer (15.9 hospital days compared with 4.98) than for a non-NOWS patient
resulting in a surge in annual costs to almost $573 million with 83% attributed to state Medicaid programs
(Strahan, 2019). While there is no accepted standard for treating NAS, non-pharmacological bundles are
recommended as an initial course of treatment moving to pharmacological care when required. Unfortunately,
non-pharmacological care (swaddling, rocking, frequent feedings, and skin contact) require significant use of
human resources (Theilking, 2017). To reduce the increasing burden on limited resources, the evidence
emerges that hospitals are trying to adapt baby products for consumers that were neither intended nor tested for
use in NAS infants as part of their non-pharmacological bundle. The objective of this application is to establish
the safety, efficacy, and acceptability of our hospital bassinet pad with stochastic vibrotactile stimulation (SVS)
technology as an adjunctive, non-pharmacological treatment to improve the care of infants with NOWS. In phase
one, we demonstrated technical feasibility, replicating the clinically critical stimulation of an investigational device
reported to significantly reduce hyperirritability and pathophysiological instabilities without altering sleep states
in NOW infants at a cost below $250/unit. We demonstrated commercial feasibility introducing the device to 51
healthcare professionals with over 70% indicating they would use the device as an adjunct to or replace non-
pharmacological bundles. To accomplish the objective, we plan to execute the following specific aims; 1)
determine the efficacy of the SVS hospital bassinet pad, 2) demonstrate the safety of the SVS hospital bassinet
pad, and 3) assess acceptability of the device with clinical staff and parents caring for infants with NOWS.
Efficacy will be established through a clinical study with NOWS infants who have reached severity criteria for
pharmacological treatment using the modified Finnegan scoring method. Cardio-respiratory monitoring will
capture measurements allowing comparison of periods when SVS is on or off. With each infant serving as its
own control, the primary outcome measure will be the stability of cardiorespiratory control. In addition to non-
clinical product testing, safety will be demonstrated by scoring sleep state durations with a masked trained
reviewer of high-resolution video recordings. A change of 20% in the duration of quiet sleep when SVS is on
compared to off will be considered significant. Acceptability will be assessed with interviews completed by clinical
staff and parents m...

## Key facts

- **NIH application ID:** 10259507
- **Project number:** 2R44DA049300-02
- **Recipient organization:** PRAPELA, INC.
- **Principal Investigator:** John Phillip Konsin
- **Activity code:** R44 (R01, R21, SBIR, etc.)
- **Funding institute:** NIH
- **Fiscal year:** 2021
- **Award amount:** $1,330,596
- **Award type:** 2
- **Project period:** 2019-06-01 → 2023-05-31

## Primary source

NIH RePORTER: https://reporter.nih.gov/project-details/10259507

## Citation

> US National Institutes of Health, RePORTER application 10259507, Prapela™ SVS: A cost-effective stochastic vibrotactile stimulation device toimprove the clinical course of infants with neonatal abstinence syndrome. (2R44DA049300-02). Retrieved via AI Analytics 2026-05-24 from https://api.ai-analytics.org/grant/nih/10259507. Licensed CC0.

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