An FDA Cleared home use treatment for Chronic Insomnia.
Week 0 – Week 4: Daily use of Modius Sleep
Week 4 – Week 16:Â 12 week follow-up post-treatment
* Individual results may vary
Study data on file with Neurovalens. (Curry et al., Brain Stimulation Journal, 2024)
of trial participants noticed an improvement in their sleep in just 4 weeks when using Modius Sleep for 30 minutes daily.
of trial participants noticed an improvement in energy / fatigue severity after using Modius Sleep for 30 minutes daily.
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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.
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
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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.
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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