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Completed

NCT Number: NCT03888274

ClearUP Longitudinal Pilot Study

Single arm, open label pilot study assessing the longitudinal home use of ClearUp Sinus Pain Relief for four weeks.

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Key information

Conditions

Sinus Pain Congestion

Age range

18 year–71 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Allergy and Asthma Associates of Santa Clara Valley Research Center

San Jose, California, 95117, United States

Who can participate

Healthy volunteers accepted: No

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

Inclusion criteria

  • 18-71 years of age (inclusive)
  • Present with symptoms of sinus pain or facial pain in the forehead, periorbital, facial, or nasal region
  • Current pain score ≥ 5 (Numeric Rating Scale 0-10)
  • Frequency of sinus/facial pain at least twice weekly for 1 month
  • Able to read and understand English
  • Agree to participate in the study
  • Able and willing to provide Informed Consent

Exclusion criteria

  • Do not meet Inclusion Criteria
  • Currently taking or recently taken any oral steroid medications in the last 90 days
  • Sinus surgery in previous 90 days
  • History of Chronic Migraine (≥ 15 headache days per month)
  • Pain location in the vertex, occiput, or temporal region of the skull or in mandibular region
  • Purulent rhinorrhea

Treatment and study plan

ClearUP Sinus Pain Relief

Device

Microcurrent Device Treatment

Primary outcomes

  1. Numeric Rating Scale for Pain

    Time frame: 4 weeks

    Change in Numeric Rating Scale for Pain from Baseline to Four Weeks. Scale range 0, no pain, to 10 severe pain.

Secondary outcomes

  1. Congestion Quantifier 7

    Time frame: 4 Weeks

    Change in Congestion Quantifier 7 from Baseline to Four Weeks. Congestion Quantifier 7 is a 7 item questionnaire that quantifies congestion symptom severity. It is scored from 0 (no congestion symptoms) to 28 (severe congestions symptoms).

  2. Numeric Rating Scale for Pain

    Time frame: 6 hours

    Acute Change in Numeric Rating Scale for Pain from Baseline to 6 Hours. Scale range 0, no pain, to 10 severe pain.

Sponsors and collaborators

Lead sponsor

Tivic Health Systems

Industry

Registry information

Important dates

Study start
2018
Primary completion
2019
Study completion
2019
First posted
Mar 25, 2019
Registry last updated
Apr 2, 2020

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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