Modius Sleep - available through the VA

A drug-free and clinically proven treatment for chronic insomnia

About Modius Sleep

Modius Sleep is an FDA-cleared medical device that improves sleep and treats insomnia.

How does it work
The hypothalamus is a crucial part of the brain that acts as a control center for many essential bodily functions. An important function of the hypothalamus is regulating your sleep-wake cycle.

Modius Sleep delivers a small and safe electrical pulse through a known neural pathway that goes to the hypothalamus. The pathway begins just behind your ear, so Modius Sleep is worn on your head and connects to this area, known as the mastoid area, behind your ear with small electrodes.

What does it feel like?
Modius Sleep delivers a small, safe electrical pulse, which may create a mild sensation during use. Many users describe a calming, swaying feeling that promotes relaxation. We recommend you stay seated while the device is active, perhaps reading a magazine, watching television or browsing the internet.

Clinically proven sleep improvements in just 4 weeks

An FDA Cleared home use treatment for Chronic Insomnia.

Study findings

147 trial participants
Participants wore Modius Sleep for 30 minutes daily for 4 weeks
More than 50% achieved a clinically meaningful reduction (6 points) in ISI score by week 4
95% of participants reported an improvement in their sleep after just 4 weeks*
At a 12 week followup, the improvement in sleep had been maintained

Week 0 – Week 4: Daily use of Modius Sleep

Week 4 – Week 16: 12 week follow-up post-treatment

A safe and effective treatment

FDA-cleared for treating chronic insomnia, ensuring rigorous safety and efficacy standards.
Designed for at-home use to improve patient compliance.
Proven therapeutic outcomes through peer-reviewed studies and clinical trials.
Automatically limits sessions to 30 minutes for patient safety and ease of use.
A strong safety profile with minimal side effects, which can be effectively managed by reducing or discontinuing stimulation as needed.

* Individual results may vary

Study data on file with Neurovalens. (Curry et al., Brain Stimulation Journal, 2024)

95%

of trial participants noticed an improvement in their sleep in just 4 weeks when using Modius Sleep for 30 minutes daily.

82%

of trial participants noticed an improvement in energy / fatigue severity after using Modius Sleep for 30 minutes daily.

Real patients | real results

What are people saying?

“I’ve had insomnia since 2020. A colleague recommended Modius Sleep. I was unsure at first—I’d tried so many things. But the results were instant. After a week, I was sleeping a solid 7 hours. I could function better at work and be a better parent. It’s given me my life back.”

Perry

“I’ve tried Ambien, Doxepin, sleep patches, and therapy. I’ve tried everything. Nothing worked! Until I received my Modius Sleep and within a few nights, I was sleeping 4–5 hours, then 6–8, then 8–9. Last night, I slept 10 straight hours. Amazing for me.”

Jan

“I’ve been using Modius Sleep for a few months and I’ve noticed I stay asleep longer, fall asleep easier, and haven’t had those ‘sleep never comes’ nights. Before, I’d lie in bed for hours and just couldn’t fall asleep. That hasn’t happened since I started using Modius Sleep.”

Jikaiah

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Important Information

Modius Sleep is a non-invasive, home-use neurostimulation device that is indicated to treat Chronic Insomnia in adults aged 22 and older.

Intended Use

The Modius Sleep device is a low risk non-invasive transdermal neurostimulation device to treat chronic insomnia. The device utilizes a technology known as electrical vestibular nerve stimulation (VeNS).

It consists of a battery-powered device designed to transcutaneously deliver low-level electrical energy (up to 1mA) to the skin behind the ears, over the mastoid processes. The delivery of this neurostimulation is through two self-adhesive electrode pads. These pads are placed on the skin behind each ear (mastoid area).

The intensity of the electric pulse can be adjusted up or down by the user. When turned on, the device delivers a small electrical impulse which stimulates the vestibular nerve. Adjustments to the stimulation level may be made using the up and down buttons on the device, which are located just above the power button.

The device can also be paused by pressing the power button twice. When finished the user removes the device and disposes of the electrode pads after each use. When the device is not being used it can be charged through a micro-USB cable. For safety reasons, it is not possible to recharge the battery while the device is in use in stimulation mode.

Indications for Use

Modius Sleep is a non-invasive, home-use neurostimulation device that is indicated to treat Chronic Insomnia in adults aged 22 and older.

Contraindications

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

Warnings & Precautions

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.

Adverse Events

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.

Manufacturer Information

Neurovalens
4th Floor, The Warehouse
7 James Street South
Belfast, United Kingdom
BT2 8DN

Medical Device FDA Approval via 510(k) Clearance

Neurovalens received FDA 510(k) clearance for Modius Sleep, intended to treat chronic insomnia on 27th October 2023.

More information

Disclaimer

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.