Modius Sleep is a new FDA-cleared neuromodulation therapy for chronic insomnia. It offers an alternative for patients who can’t access, tolerate, or benefit from CBT-I or medication.
The treatment uses a wearable VeNS device to deliver non-invasive, at-home therapy that supports better sleep. It’s available to prescribe through a national commercial program from ResMed and Neurovalens.
Modius Sleep is a new FDA-cleared neuromodulation therapy for chronic insomnia. It offers an alternative for patients who can’t access, tolerate, or benefit from CBT-I or medication.
The treatment uses a wearable VeNS device to deliver non-invasive, at-home therapy that supports better sleep. It’s available to prescribe through a national commercial program from ResMed and Neurovalens.
Expand Access in Your State
We have launched a nationwide commercial program enabling physicians to prescribe Modius Sleep with ease.
The pilot program is already active across multiple states with dozens of participating sleep physicians. Help expand access to this FDA-cleared therapy for patients in your community.
This program is designed to complement, not complicate, your clinical workflow. We provide end-to-end support to ensure effective patient care and physician confidence:
Accessible via a $99/month rent to own model to reduce upfront burden and support adoption.
Patients receive onboarding, usage guidance, and ongoing support directly from our dedicated clinical team, minimizing clinic staff involvement.
Quick-start resources and peer-facing education help you incorporate Modius Sleep with ease.
Track patient progress through regular ISI score updates and patient-reported outcomes.
Modius Sleep is revolutionizing how we treat chronic insomnia. This FDA-cleared, non-invasive device uses Vestibular Stimulation (VeNS) to enhance sleep quality safely and effectively. Designed for integration into clinical practice, Modius Sleep offers an evidence-based path for physicians to improve patient outcomes with minimal disruption to existing workflows.
Why Modius Sleep?
How does it work?
Modius Sleep leverages Vestibular Stimulation (VeNS) to deliver gentle electrical pulses to the brainstem, restoring the natural sleep-wake balance without medication or invasive techniques.
*Modius Sleep was not evaluated in combination with other therapies during clinical trials. No claims are made regarding enhanced effectiveness when used alongside CBT-I or other treatments.
An FDA Cleared home use treatment for Chronic Insomnia.
* Individual results may vary
A high proportion of patients self-reported an improvement in sleep using ISI after 4 weeks of use, indicating early therapeutic response.
More than 50% achieved a reduction in ISI scores consistent with clinically meaningful improvement within the initial 2–4 weeks.
Sustained effects were observed at 12-week follow-up, suggesting lasting treatment impact.
Study data on file with Neurovalens. (Curry et al., Brain Stimulation Journal, 2024)
Clinical studies show that Modius Sleep can significantly improve sleep quality in adults with chronic insomnia. Published in Brain Stimulation and validated through rigorous trials, Modius Sleep is an evidence-based solution trusted by physicians and patients alike.
Modius Sleep is a non-invasive, home-use neurostimulation device that is indicated to treat Chronic Insomnia in adults aged 22 and older.
Modius Sleep should not be used if:
• You are under the age of 22
• You are suffering from skin irritation behind the ears (e.g., eczema)
• You have vestibular dysfunction or inner ear disease
• You suffer from reflex vestibular epilepsy
• You are pregnant
• You have an implanted pacemaker, cardiac defibrillator or neurostimulation device
1. Please read the user manual and make sure that you understand the instructions before you use the product.
2. Only place stimulation pads on the mastoids, behind the ears, as directed in the instructions provided. Do not place on your chest or elsewhere on the head or neck.
3. If an unexpected reaction occurs, discontinue use of Modius Sleep immediately.
4. Keep this product away from children as small items such as stimulation pads are choking hazards.
5. It is recommended that you use this device only while seated.
6. Modius Sleep must not be used while driving or operating machinery of any kind.
7. Modius Sleep is for adults 22 and older only.
8. Dispose of stimulation pads in a suitable bin after use.
9. If you feel any discomfort during a session, pause the session and reduce the stimulation level via the buttons on the device until it is at a comfortable level before resuming your session.
10. Possible hazards or adverse effects include skin irritation; discomfort from the stimulation; sensation of feeling off-balance; dizziness; nystagmus (eye movements); blurred or flashing vision; headache; nausea and tinnitus. If a problem persists, please consult your physician.
11. To mitigate the risk of dizziness, the device must be worn when seated, and start stimulation at a low level and increase gradually to the highest comfortable level. If you do experience dizziness, stop stimulation by turning off or removing the device. If dizziness persists, please consult your physician.
12. To mitigate the risk of headaches, start stimulation at a low level and increase gradually to the highest comfortable level. If you do experience a headache, stop stimulation by turning off or removing the device. If a headache persists, please consult your physician.
13. It is recommended that you use Modius Sleep for 30 minutes per day. As a safety feature, the device will automatically stop stimulation after 30 minutes of use.
14. The Modius Sleep device has not been evaluated in the following populations: diagnosis of HIV infection or AIDs, history of stroke or severe head injury, diagnosis of a current psychotic disorder or current major depressive episode.
15. The Modius Sleep device has not been evaluated in populations who have used prescription or over the counter sleep medications 4 weeks prior to device use, and during device use.
16. Some users may have a response that may affect their ability to perform potentially hazardous tasks, such as operating a motor vehicle or heavy machinery for up to several hours after treatment. However, no significant lasting side effects have been reported.
Clinical and research studies report the possibility of mild adverse effects including: skin irritation, discomfort from the stimulation, sensation of feeling off-balance, dizziness, nystagmus (eye movements), blurred or flashing vision, headache, nausea, and tinnitus.
The risk of these adverse effects occurring is usually mitigated by reducing or stopping the stimulation. If you do experience these adverse effects, stop stimulation by turning off or removing the device.
Neurovalens
4th Floor, The Warehouse
7 James Street South
Belfast, United Kingdom
BT2 8DN
Neurovalens received FDA 510(k) clearance for Modius Sleep, intended to treat chronic insomnia on 27th October 2023.
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This is s promotional webpage. The contents are not intended to be medical advice and should not be considered medical advice. You should consult healthcare professionals for medical guidance.
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Neurovalens is a global health-tech company that creates non-invasive neurostimulation products used to solve some of the world’s greatest health challenges.
Our medical device technology offers unparalleled transdermal activation of the homeostatic nuclei of the brainstem and hypothalamus, allowing for alterations in autonomic function, circadian regulation and Neuro-metabolic influence.
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