A User Study of the Soniflow System for Nasal Congestion Relief
1 other identifier
interventional
50
1 country
1
Brief Summary
The Soniflow System consists of an acoustic vibrational headband paired with a Smartphone App to provide rapid relief of nasal congestion.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P25-P50 for not_applicable
Started Jul 2020
Shorter than P25 for not_applicable
1 active site
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
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Study Timeline
Key milestones and dates
Study Start
First participant enrolled
July 15, 2020
CompletedPrimary Completion
Last participant's last visit for primary outcome
January 26, 2021
CompletedStudy Completion
Last participant's last visit for all outcomes
January 26, 2021
CompletedFirst Submitted
Initial submission to the registry
May 23, 2021
CompletedFirst Posted
Study publicly available on registry
June 2, 2021
CompletedResults Posted
Study results publicly available
October 12, 2023
CompletedOctober 12, 2023
October 1, 2023
7 months
May 23, 2021
July 26, 2023
October 11, 2023
Conditions
Outcome Measures
Primary Outcomes (1)
Total Nasal Symptom Score
TNSS is a measure of nasal congestion, measured as the sum of four symptom scores for rhinorrhea, nasal congestion, nasal itching, and sneezing (using a scale of 0=None, 1=Mild, 2=Moderate, or 3=Severe). The minimum TNSS value is 0. The maximum TNSS value is 12. Lower TNSS score means a better outcome
20 minutes
Secondary Outcomes (2)
Visual Analog Scale (VAS) for Headache
20 minutes
Visual Analog Scale (VAS) for Facial Pain
20 minutes
Study Arms (1)
Treatment
EXPERIMENTALTreatment using acoustic energy
Interventions
Treatment using acoustic vibrational headband worn circumferentially at the level of the forehead paired with a Smartphone App.
Eligibility Criteria
You may qualify if:
- Subject is \>18 years of age
- Subject has had moderate to severe symptoms of nasal congestion for \>3 months (TNSS rating of 2 or 3)
- Subject has signed IRB-approved informed consent form
You may not qualify if:
- Subject has neurologic comorbidities
- Subject has active dental infection
- Subject is pregnant
- Subject has implanted intracranial electrostimulation device(s) (e.g. cochlear implant, deep brain stimulator)
- Subject has undergone sinonasal or craniomaxillofacial surgery within the lats 3 months
- Subject has been diagnosed with intracranial hemorrhage within the last 6 months
- Subject has open scalp wounds or rashes
- Subject has any history of craniotomy without replacement of a bone flap
- Subject has elevated sensitivity to sound
- Any physical condition that in the investigator's opinion would prevent adequate study participation or pose increased risk
Contact the study team to confirm eligibility.
Sponsors & Collaborators
Study Sites (1)
San Francisco Otolaryngology Medical Group
San Francisco, California, 94108, United States
MeSH Terms
Conditions
Condition Hierarchy (Ancestors)
Results Point of Contact
- Title
- Paramesh Gopi
- Organization
- Sound Health Systems
Study Officials
- PRINCIPAL INVESTIGATOR
Jacob Johnson, MD
Principal Investigator
Publication Agreements
- PI is Sponsor Employee
- No
- Restrictive Agreement
- No
Study Design
- Study Type
- interventional
- Phase
- not applicable
- Allocation
- NA
- Masking
- NONE
- Purpose
- TREATMENT
- Intervention Model
- SINGLE GROUP
- Sponsor Type
- INDUSTRY
- Responsible Party
- SPONSOR
Study Record Dates
First Submitted
May 23, 2021
First Posted
June 2, 2021
Study Start
July 15, 2020
Primary Completion
January 26, 2021
Study Completion
January 26, 2021
Last Updated
October 12, 2023
Results First Posted
October 12, 2023
Record last verified: 2023-10
Data Sharing
- IPD Sharing
- Will not share