NCT03466879

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.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
72

participants targeted

Target at P50-P75 for all trials

Timeline
Completed

Started Feb 2018

Shorter than P25 for all trials

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

February 2, 2018

Completed
1 month until next milestone

First Submitted

Initial submission to the registry

March 9, 2018

Completed
6 days until next milestone

First Posted

Study publicly available on registry

March 15, 2018

Completed
4 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

July 21, 2018

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

July 21, 2018

Completed
Last Updated

December 26, 2018

Status Verified

December 1, 2018

Enrollment Period

6 months

First QC Date

March 9, 2018

Last Update Submit

December 21, 2018

Conditions

Sinus; Inflammation

Outcome Measures

Primary Outcomes (1)

  • Pain reduction

    Average decrease in pain score of the SYNUS device is greater than the average decrease is pain score for the sham/placebo device.

    10 minutes

Study Arms (2)

Active device users

Users will use an active SYNUS Pain Relief device

Device: SYNUS Pain Relief device

Sham device users

Users will use a sham SYNUS Pain Relief device that is not providing treatment

Interventions

SYNUS Pain Relief deviceDEVICE

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

Active device users

Eligibility Criteria

Age18 Years - 99 Years
Sexall
Age GroupsAdult (18-64), Older Adult (65+)
Sampling MethodProbability Sample
Study Population

At least 58 subjects suffering from sinus pain

You may qualify if:

  • 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

You may not qualify if:

  • 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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Stanford University

Stanford, California, 94306, United States

Location

MeSH Terms

Conditions

Sinusitis

Condition Hierarchy (Ancestors)

Respiratory Tract InfectionsInfectionsParanasal Sinus DiseasesNose DiseasesRespiratory Tract DiseasesOtorhinolaryngologic Diseases

Study Officials

  • Jayakar Nayak, MD

    Stanford University

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
observational
Observational Model
CASE CONTROL
Time Perspective
PROSPECTIVE
Sponsor Type
INDUSTRY
Responsible Party
SPONSOR

Study Record Dates

First Submitted

March 9, 2018

First Posted

March 15, 2018

Study Start

February 2, 2018

Primary Completion

July 21, 2018

Study Completion

July 21, 2018

Last Updated

December 26, 2018

Record last verified: 2018-12

Data Sharing

IPD Sharing
Will not share

Locations

US(1)