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How does the ClearUP™ Sinus Pain Relief device work?

ClearUP™ Sinus Pain Relief is a microcurrent therapy for sinus pain. As the device glides along the cheek, nose, and brow bone, it locates areas of the skin with low impedance, where current can pass most easily. At these treatment points, the device emits low-current electrical stimulation, called Microcurrent, to stimulate underlying nerve fibers. The trigeminal nerve, which transmits pain and sensation signals from the sinuses and nasal cavity, has branches that are found in the facial skin.

Electrical stimulation of nerves has been used to reduce the sensory perception of pain. Research has also shown that electrical stimulation can activate sympathetic nerve fibers and promote constriction of blood vessels, which can result in the shrinking swollen tissue.

Instructions
Glide device along cheek, nose, brow bone.

Clinical Study: A User Study of ClearUP Sinus Pain Relief, a device developed by Tivic Health Systems Inc

June 2018

Study Site: Stanford Sinus Center, Stanford University Medical School

Principal Investigator: Jayakar Nayak, MD, PhD, Associate Professor and Director of Rhinology Research, Stanford University

Study Design: Seventy-one participants with self-reported sinus pain were recruited from a rhinology practice and from the surrounding community and were randomly assigned to office-based use of an active (n=38) or sham (n=33) handheld ClearUPTM Sinus Pain Relief microcurrent device. The ClearUP device, which automatically activates in regions of low impedance, was repetitively applied by the patient to the bilateral periorbital areas for five minutes. Visual analogue scale for pain (0-10) was collected before, and ten minutes after, treatment. A minimum visual analog pain score of 4 was required for study enrollment. Users, unaided, self-trained in the use of the device and self-administered the treatment.

Study Status: Completed June 2018

ClinicalTrials.Gov Identifier: NCT03466879

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Abstract: Microcurrent technology for rapid relief of sinus pain: A randomized, placebo controlled, double-blinded clinical trial. To be presented at the American Rhinologic Society Annual Meeting, October 2018, Atlanta, GA.

Coming Oct 2018

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Journal Publication: Microcurrent technology for rapid relief of sinus pain: a randomized, placebo controlled, double-blinded clinical trial. Ximena A. Maul, MD1,2,*, Nicole A. Borchard1,*, Jayakar V. Nayak, MD, PhD1. In Preparation.

Coming soon

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New Clinical Study: At-Home Use of ClearUP Sinus Pain Relief For Treating Sinus Pain

Fall, 2018

Study Sites: tbd
Investigators: tbd
Study Design: 250-participant, double-blind, randomized, controlled trial to be carried out at multiple study sites in the United States. Participants with sinus pain will self-treat themselves at home with either an active microcurrent device or a sham device for multiple weeks followed by follow up.
Study Status: In Development
ClinicalTrials.Gov Identifier: Coming Soon

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