# Transcranial ultrasound device for enhancing sleep in OUD

> **NIH NIH R43** · ATTUNE NEUROSCIENCES, INC. · 2021 · $319,441

## Abstract

Summary
The opioid use disorder (OUD) is a rapidly expanding health epidemic in the United States with little progress in
treatment efficacy. Insufficient sleep represents the most severe and pervasive symptoms of both phases of
withdrawal and persist despite treatment. Because sleep loss plays a key role in anxiety and daily routine, its
disruption is a major factor in a patient’s relapse evidenced by the higher incidence of relapse in OUD patients
with sleep disorders. Sleep dysfunction in OUD is characterized by significant loss in slow wave sleep (SWS),
which are critical components of the benefits of sleep. In patients with severe withdrawal, sleep may consist
almost entirely of brief periods of rapid eye movement (REM) with sparse non-REM (NREM) sleep interrupted
by numerous awakenings. Given the prevalence of poor sleep quality in OUD and the association with relapse,
treatments enhancing the restful effects of sleep could reduce the rate of relapse. However, commonly
prescribed sleep medications have sedative and hypnotic effects with a risk of dependency too great for patients
with OUD. Thus, new interventions to augment sleep are a critical unmet medical need which could have an
outsized influence on their life. Here, we build off of research in humans and animal models demonstrating that
focused ultrasound can stimulate brain regions underlying SWS. We will design a wearable device integrating
sleep recordings and steerable ultrasound arrays. Ultrasound arrays will target the thalamus, a core SWS
structure, using MRI maps of patient’s brains and skulls. We will design custom EEG analytics software for
delivering the stimulus during the rising phase of slow waves to enhance wave amplitude, duration, and beneficial
effects. We will perform a human factors study with OUD patients to assess comfort and usability for redesigning
the wearable. Throughout the project we will interact with the FDA in efforts to gain approval for a phase II study
with OUD patients.

## Key facts

- **NIH application ID:** 10390994
- **Project number:** 1R43DA055399-01
- **Recipient organization:** ATTUNE NEUROSCIENCES, INC.
- **Principal Investigator:** Rajiv Mahadevan
- **Activity code:** R43 (R01, R21, SBIR, etc.)
- **Funding institute:** NIH
- **Fiscal year:** 2021
- **Award amount:** $319,441
- **Award type:** 1
- **Project period:** 2021-09-30 → 2023-08-31

## Primary source

NIH RePORTER: https://reporter.nih.gov/project-details/10390994

## Citation

> US National Institutes of Health, RePORTER application 10390994, Transcranial ultrasound device for enhancing sleep in OUD (1R43DA055399-01). Retrieved via AI Analytics 2026-06-08 from https://api.ai-analytics.org/grant/nih/10390994. Licensed CC0.

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