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Completed

NCT Number: NCT03466879

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

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.

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Key information

Conditions

Sinus; Inflammation Infections Nose Diseases Otorhinolaryngologic Diseases Paranasal Sinus Diseases Respiratory Tract Diseases Respiratory Tract Infections Sinusitis

Age range

18 year–99 year

Sex eligibility

All sexes

Study type

Observational

Primary location

Stanford University

Stanford, California, 94306, United States

About this study

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.

Who can participate

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

SYNUS Pain Relief device

Device

SYNUS Pain Relief is a handheld micro-current TENS device used for the temporary relief of sinus pain.

Primary outcomes

  1. Pain reduction

    Time frame: 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.

Sponsors and collaborators

Lead sponsor

Tivic Health Systems

Industry

Collaborators

  • Stanford University

Registry information

Important dates

Study start
2018
Primary completion
2018
Study completion
2018
First posted
Mar 15, 2018
Registry last updated
Dec 26, 2018

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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