Non-pharmaceutical systems and methods of treating the symptoms of fibromyalgia
Inventors
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Assignees
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Sana HealthMilitary Operational Medicine funded for PTSD, Adjustment Disorder and Pain and Sleep (over $5m). 3 trials in progress. Sana Health is an FDA Breakthrough Designated Device, currently in front of the FDA for Neuropathic Pain as a de novo - expecting to be on market Q4 2025. Sana is a wearable audiovisual neuromodulation device, that provides anxiety and pain relief, and sleep on demand. $25m raised to date, and in the middle of a Series A extension SAFE note round.
Military Operational Medicine funded for PTSD, Adjustment Disorder and Pain and Sleep (over $5m). 3 trials in progress. Sana Health is an FDA Breakthrough Designated Device, currently in front of the FDA for Neuropathic Pain as a de novo - expecting to be on market Q4 2025. Sana is a wearable audiovisual neuromodulation device, that provides anxiety and pain relief, and sleep on demand. $25m raised to date, and in the middle of a Series A extension SAFE note round.
Publication Number
US-11524135-B2
Publication Date
2022-12-13
Expiration Date
2036-11-23
Abstract
Non-pharmaceutical systems and methods of treating the symptoms of fibromyalgia are described. The method includes administering a therapeutically effective amount of a sensory stimulus to a person, wherein the sensory stimulus includes one or more visual stimuli and one or more auditory stimuli.
Core Innovation
The invention provides non-pharmaceutical systems and methods for treating symptoms of fibromyalgia by administering a therapeutically effective amount of sensory stimulus to a person. The sensory stimulus includes one or more visual stimuli and one or more auditory stimuli, and may be provided using devices such as a headset worn on the person's head. The sensory stimuli may include amplitude modulated light sources and amplitude modulated audio frequencies, optionally organized in temporal sequences or patterns with different pulse frequencies.
Fibromyalgia is a medical condition characterized by chronic widespread pain, heightened pain response, sleep problems, fatigue, and cognitive issues. Current treatments are challenging and include medications, cognitive behavioral therapy, and lifestyle recommendations, but medications often have limited efficacy or undesirable side effects. Therefore, there is a need for novel, non-pharmaceutical tools and methods for treating fibromyalgia symptoms.
Claims Coverage
The patent includes two independent claims covering methods and systems for treating fibromyalgia using sensory stimuli. Three main inventive features are identified from these claims.
Administering sensory stimulus including visual and auditory stimuli
A method of treating fibromyalgia by administering a therapeutically effective amount of a sensory stimulus to a person, where the sensory stimulus includes one or more visual stimuli and one or more auditory stimuli.
Alternating sensory stimuli between specific left/right visual and auditory patterns
The sensory stimulus alternates between a first sensory stimuli simultaneously providing a left visual stimuli pattern to the left eye and a right auditory stimuli pattern to the right side of the head, and a second sensory stimuli simultaneously providing a right visual stimuli pattern to the right eye and a left auditory stimuli pattern to the left side of the head. The auditory stimuli patterns comprise sequences of stimuli including at least a first and second pulse frequency within specified frequency ranges.
System comprising a headset configured to administer alternating visual and auditory stimuli patterns
A system for treating fibromyalgia, comprising a headset worn on the head of a person, configured to administer a therapeutically effective amount of sensory stimulus including alternating visual and auditory stimuli patterns as described, with pulse frequencies within specified ranges.
The independent claims focus on administering therapeutically effective sensory stimuli comprising visual and auditory components that alternate between controlled patterns delivered to left and right sides, with specific pulse frequency ranges, via a headset system for treating symptoms of fibromyalgia.
Stated Advantages
Provides a non-pharmaceutical method to treat symptoms of fibromyalgia, overcoming disadvantages of prior art medication-based treatments.
Combining multiple sensory stimuli (visual, auditory, and optionally tactile) simultaneously or in sequences produces improved therapeutic benefits compared to individual stimuli alone.
Enables treatment personalization and optimization by modulating stimuli intensity and timing based on real-time physiological measurements from sensors such as heart rate variability.
Improves symptoms including pain, anxiety, depression, and sleep quality, demonstrated by clinical study results with statistical significance.
Documented Applications
Treatment of fibromyalgia symptoms including anxiety, pain, depression, and sleep disorders using a sensory stimulation headset.
Use in managing relaxation and improving tolerance to pain by administering sensory stimuli with monitored physiological feedback.
Therapy for treatment-resistant fibromyalgia patients who have failed other drug regimens and standard care.
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