A User Study of SYNUS Pain Relief Made by Tivic Health Systems

Completed

• Conditions: Sinus; Inflammation
• Interventions: Device: SYNUS Pain Relief device

• Registration Number: NCT03466879
• Lead Sponsor: Tivic Health Systems

Brief Summary

Demonstrate the ability of subjects suffering from sinus pain to self-treat with the SYNUS Pain Relief device and to obtain pain relief compared to a sham/placebo device.

Detailed Description

A prospective study of at least 58 recruited subjects suffering from sinus pain. At least 30 of the subjects will be randomly selected to use the SYNUS Pain Relief device, a device that uses micro-currents to stimulate major nerve fibers passing from the sinus passages through various foramina to the facial skin. Subjects will read manufacturer's provided Instructions-For-Use (IFU's) and without help from staff will proceed to self-perform the treatment. The other subjects will follow the same procedure but use a sham/placebo device with no stimulating current. Subjects will be blinded as to the device they use. Prior to and 10 minutes following the stimulation, subjects will score their pain level on a visual analogue scale.

Study Timeline

• Study Start: 2018-02-02
• Study First Submitted: 2018-03-09
• Study First Submitted QC: 2018-03-09
• Study First Posted: 2018-03-15
• Primary Completion: 2018-07-21
• Study Completion: 2018-07-21
• Status Verified: 2018-12
• Last Update Submitted: 2018-12-21
• Last Update Posted: 2018-12-26

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 72

Inclusion Criteria

• Be 18 years of age and older
• Present with symptoms of sinus pain and pressure
• Have an initial sinus pain score of 4 or more on the visual analogue scale
• Be able to read and understand English
• Agree to participate in the study
• Be able and willing to provide Informed Consent

Exclusion Criteria

• Do not meet Inclusion Criteria
• Have currently a dental infection
• Have currently abnormal cranial nerve or other neurological findings or symptoms that would require prompt medical attention
• Be currently pregnant
• Have implanted electrostimulation devices including a pacemaker, a DBS or a cochlear implant

Study & Design

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Arm && Interventions

Group	Intervention	Description
Active device users	SYNUS Pain Relief device	Users will use an active SYNUS Pain Relief device

Primary Outcome Measures

Name	Time	Method
Pain reduction	10 minutes	Average decrease in pain score of the SYNUS device is greater than the average decrease is pain score for the sham/placebo device.

Trial Locations

Locations (1)

Stanford University; 🇺🇸 Stanford, California, United States