Congestion, Sinus Pain
Conditions
Brief summary
Single arm, open label pilot study assessing the longitudinal home use of ClearUp Sinus Pain Relief for four weeks.
Interventions
DEVICEClearUP Sinus Pain Relief
Microcurrent Device Treatment
Sponsors
Tivic Health Systems
Study design
Allocation
NA
Intervention model
SINGLE_GROUP
Primary purpose
TREATMENT
Masking
NONE
Eligibility
Sex/Gender
ALL
Age
18 Years to 71 Years
Healthy volunteers
No
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
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| 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
| Measure | Time frame | Description |
|---|---|---|
| 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. |
Countries
United States
Participant flow
Participants by arm
| Arm | Count |
|---|---|
| Active ClearUP Sinus Pain Relief: Microcurrent Device Treatment | 30 |
| Total | 30 |
Baseline characteristics
| Characteristic | Active | — |
|---|---|---|
| Age, Categorical <=18 years | 0 Participants | — |
| Age, Categorical >=65 years | 1 Participants | — |
| Age, Categorical Between 18 and 65 years | 29 Participants | — |
| Age, Continuous | 43.4 Years STANDARD_DEVIATION 12.1 | — |
| Race and Ethnicity Not Collected | — | — Participants |
| Region of Enrollment United States | 30 participants | — |
| Sex: Female, Male Female | 21 Participants | — |
| Sex: Female, Male Male | 9 Participants | — |
Adverse events
| Event type | EG000 affected / at risk |
|---|---|
| deaths Total, all-cause mortality | 0 / 30 |
| other Total, other adverse events | 4 / 30 |
| serious Total, serious adverse events | 0 / 30 |
Outcome results
Primary
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
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| Active | Numeric Rating Scale for Pain | Baseline | 6.5 score on a scale | Standard Error 0.2 |
| Active | Numeric Rating Scale for Pain | 4 Weeks | 3.6 score on a scale | Standard Error 0.36 |
Secondary
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
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| Active | Congestion Quantifier 7 | Baseline | 18.1 score on a scale | Standard Error 0.85 |
| Active | Congestion Quantifier 7 | 4 Weeks | 11.0 score on a scale | Standard Error 1.05 |
Secondary
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
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| Active | Numeric Rating Scale for Pain | Baseline | 6.5 score on a scale | Standard Error 0.2 |
| Active | Numeric Rating Scale for Pain | 6 Hours | 4.3 score on a scale | Standard Error 0.37 |