ClearUP Longitudinal Pilot Study

Not Applicable

Completed

• Conditions: Congestion; Sinus Pain

• Registration Number: NCT03888274
• Lead Sponsor: Tivic Health Systems

Brief Summary

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

Detailed Description

Not available

Study Timeline

• Study Start: 2018-11-29
• Primary Completion: 2019-02-13
• Study Completion: 2019-03-01
• Study First Submitted: 2019-03-21
• Study First Submitted QC: 2019-03-22
• Study First Posted: 2019-03-25
• Status Verified: 2020-03
• Results First Submitted: 2020-03-09
• Results First Submitted QC: 2020-03-23
• Last Update Submitted: 2020-03-23
• Results First Posted: 2020-04-02
• Last Update Posted: 2020-04-02

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 30

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

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: SINGLE_GROUP

Primary Outcome Measures

Name	Time	Method
Numeric Rating Scale for Pain	4 weeks	Change in Numeric Rating Scale for Pain from Baseline to Four Weeks. Scale range 0, no pain, to 10 severe pain.

Secondary Outcome Measures

Name	Time	Method
Congestion Quantifier 7	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).
Numeric Rating Scale for Pain	6 hours	Acute Change in Numeric Rating Scale for Pain from Baseline to 6 Hours. Scale range 0, no pain, to 10 severe pain.

Trial Locations

Locations (1)

Allergy and Asthma Associates of Santa Clara Valley Research Center; 🇺🇸 San Jose, California, United States