# Wearable Device for Prevention of Opioid-Induced Respiratory Depression, Hypoxemia and Death

> **NIH NIH R43** · LLOYD OLSON, MD, LLC · 2020 · $349,336

## Abstract

Project Summary/Abstract
Significance: Opioids kill 250 persons daily in the US, mostly by respiratory arrest.
Hypoxemia (low blood oxygen), typically precedes respiratory arrest. Timely
detection and correction of hypoxemia saves lives. The Oxalert EPO is a wearable
device designed to automatically restore breathing and reverse hypoxemia without
human intervention.
The Oxalert EPO (Enhanced Pulse Oximeter) is an FDA designated Breakthrough
Device, (...more effective diagnosis or treatment for a life-threatening condition... for
which no equivalent alternatives exist... in the best interests of patients.)24
The FDA recognizes our initial proposed Indication for Use in hospitalized post-
operative patients receiving opioids. We intend to confirm feasibility both in-hospital
and at home, in order to support a later FDA Indication for Use in patients at home
using opioids. The Center for Medicare and Medicare Services (CMS) will now
reimburse automatically for FDA-approved Breakthrough Devices.
Preliminary Data: Zornow showed that automatic arousal was superior to 1:1
nursing care.17 Sessler incidentally verified the "Arousal Effect" in a study of 1200
post-op in-patients.16
Specific Aims: AIM1) Prove feasibility of the Oxalert arousal device for restoring
breathing and reversing hypoxemia in post-operative patients receiving opioids.
AIM2) Determine statistical scalability needs for future Phase II study.
AIM3) Evaluate patient tolerance, nurse feedbacl and human factors/usability.
AIM4) Compare the extent of nocturnal oxygen desatuations in home-use before
and after surgery, with and without Oxalert interventions.
Summary: Breakthrough Device status should facilitate FDA approval for the
Oxalert EPO. Devices with a favorable Risk:Benefit ratio under the Twenty-First
Cures Act qualify for less FDA emphasis on lengthy pre-market studies as opposed
to post-market data in order to expedite patient access. We hope to find the
shortest path to getting this device to all who might benefit.

## Key facts

- **NIH application ID:** 10012569
- **Project number:** 1R43DA050336-01A1
- **Recipient organization:** LLOYD OLSON, MD, LLC
- **Principal Investigator:** Lloyd Olson
- **Activity code:** R43 (R01, R21, SBIR, etc.)
- **Funding institute:** NIH
- **Fiscal year:** 2020
- **Award amount:** $349,336
- **Award type:** 1
- **Project period:** 2020-06-15 → 2021-06-30

## Primary source

NIH RePORTER: https://reporter.nih.gov/project-details/10012569

## Citation

> US National Institutes of Health, RePORTER application 10012569, Wearable Device for Prevention of Opioid-Induced Respiratory Depression, Hypoxemia and Death (1R43DA050336-01A1). Retrieved via AI Analytics 2026-05-23 from https://api.ai-analytics.org/grant/nih/10012569. Licensed CC0.

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