Treatment of Sinus Headache Using a Novel Device That Combines Acoustic Vibration with Oscillating Expiratory Pressure
Overview
Tab Title Description
Study type
InterventionalDescribes the nature of a clinical study. Types include:
- Observational study — observes people and measures outcomes without affecting results.
- Interventional study (clinical trial) — studies new tests, treatments, drugs, surgical procedures or devices.
- Medical records research — uses historical information collected from medical records of large groups of people to study how diseases progress and which treatments and surgeries work best.
Study IDs
Site IRB
- Jacksonville, Florida: 22-001904
- Scottsdale/Phoenix, Arizona: 22-001904
NCT ID: NCT05479604
About this study
This study is utilizing the Mayo Clinic Cures at Home participation services. For questions regarding home research services in this study please reach out to curesathome@mayo.edu.
The purpose of this study is to investigate facial pain improvement with twice-daily use of a novel device combing acoustic vibration with oscillating expiratory pressure compared with a sham device in male and female participants > 18 years of age with sinus pain/headache lacking objective evidence of sinonasal inflammation.
Participation eligibility
Participant eligibility includes age, gender, type and stage of disease, and previous treatments or health concerns. Guidelines differ from study to study, and identify who can or cannot participate. There is no guarantee that every individual who qualifies and wants to participate in a trial will be enrolled. Contact the study team to discuss study eligibility and potential participation.
Inclusion Criteria:
- Participant must be ≥ 18 years of age inclusive, at the time of signing the informed consent.
- Participants who are overtly healthy as determined by medical evaluation including medical history and physical examination.
- Capable of giving signed informed consent which includes compliance with the requirements and restrictions listed in the informed consent form (ICF) and in this protocol.
- Facial pain or pressure for > 3 months of symptom duration.
- Pain/pressure VAS score of > 5.
Exclusion Criteria:
- Upper respiratory illness within the last 2 weeks.
- History of severe epistaxis.
- Known pregnancy.
- Allergic sensitivity to silicone or any other component of device.
- Sinonasal surgery in the last 3 months.
- Topical decongestant use in the last week.
- Nasal polyposis, purulence/edema, or other signs of sinusitis on exam.
- Sinusitis on imaging.
- Nasal crusting or ulceration on exam.
- Inability to read or understand English.
Eligibility last updated 2/18/22. Questions regarding updates should be directed to the study team contact.
Participating Mayo Clinic locations
Study statuses change often. Please contact the study team for the most up-to-date information regarding possible participation.
| Mayo Clinic Location |
Status |
|
Jacksonville, Fla.
Mayo Clinic principal investigator Angela Donaldson, M.D. |
Closed for enrollment |
|
Scottsdale/Phoenix, Ariz.
Mayo Clinic principal investigator Amar Miglani, M.D. |
Closed for enrollment |
|
More information
Publications
Publications are currently not available