ClearUP Longitudinal Pilot Study

N/ACompletedNCT03888274

Tivic Health Systems30 enrolled

Overview

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

Study Type

INTERVENTIONAL

Allocation

Purpose

TREATMENT

Masking

NONE

Enrollment

Conditions

Sinus Pain Congestion

Interventions

ClearUP Sinus Pain ReliefDEVICE

Microcurrent Device Treatment

Eligibility

Sex: ALLMin age: 18 YearsMax age: 71 Years

Medical Language ↔ Plain English

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

Locations (1)

Allergy and Asthma Associates of Santa Clara Valley Research Center

San Jose, California, United States

Outcomes

Primary Outcomes

Numeric Rating Scale for Pain

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

Time frame: 4 weeks

Secondary Outcomes

Congestion Quantifier 7

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).

Time frame: 4 Weeks

Numeric Rating Scale for Pain

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

Time frame: 6 hours

Data from ClinicalTrials.gov

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