A User Study of the Soniflow System for Nasal Congestion Relief
NCT ID: NCT04910139
Last Updated: 2023-10-12
Study Results
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View full resultsBasic Information
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COMPLETED
NA
50 participants
INTERVENTIONAL
2020-07-15
2021-01-26
Brief Summary
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Detailed Description
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Conditions
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Study Design
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NA
SINGLE_GROUP
TREATMENT
NONE
Study Groups
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Treatment
Treatment using acoustic energy
Soniflow System
Treatment using acoustic vibrational headband worn circumferentially at the level of the forehead paired with a Smartphone App.
Interventions
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Soniflow System
Treatment using acoustic vibrational headband worn circumferentially at the level of the forehead paired with a Smartphone App.
Other Intervention Names
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Eligibility Criteria
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Inclusion Criteria
2. Subject has had moderate to severe symptoms of nasal congestion for \>3 months (TNSS rating of 2 or 3)
3. Subject has signed IRB-approved informed consent form
Exclusion Criteria
2. Subject has active dental infection
3. Subject is pregnant
4. Subject has implanted intracranial electrostimulation device(s) (e.g. cochlear implant, deep brain stimulator)
5. Subject has undergone sinonasal or craniomaxillofacial surgery within the lats 3 months
6. Subject has been diagnosed with intracranial hemorrhage within the last 6 months
7. Subject has open scalp wounds or rashes
8. Subject has any history of craniotomy without replacement of a bone flap
9. Subject has elevated sensitivity to sound
10. Any physical condition that in the investigator's opinion would prevent adequate study participation or pose increased risk
18 Years
ALL
Yes
Sponsors
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Third Wave Therapeutics
INDUSTRY
Responsible Party
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Principal Investigators
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Jacob Johnson, MD
Role: PRINCIPAL_INVESTIGATOR
Principal Investigator
Locations
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San Francisco Otolaryngology Medical Group
San Francisco, California, United States
Countries
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Provided Documents
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Document Type: Study Protocol and Statistical Analysis Plan
Other Identifiers
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CP-001
Identifier Type: -
Identifier Source: org_study_id
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