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Treatment of Sinus Headache Using a Novel Device That Combines Acoustic Vibration With Oscillating Expiratory Pressure

Primary Purpose

Facial Pain

Status
Recruiting
Phase
Not Applicable
Locations
United States
Study Type
Interventional
Intervention
SinuSonic
Sham Device
Sponsored by
Mayo Clinic
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Facial Pain focused on measuring Facial Pressure

Eligibility Criteria

18 Years - undefined (Adult, Older Adult)All SexesDoes not accept healthy volunteers

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.

Sites / Locations

  • Mayo Clinic ArizonaRecruiting
  • Mayo Clinic Florida

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

Sham Comparator

Arm Label

SinuSonic Group

Sham Group

Arm Description

Subjects will use the SinuSonic device for 2 minutes twice daily for 8 weeks

Subjects will use the sham device for 2 minutes twice daily for 8 weeks

Outcomes

Primary Outcome Measures

Change in facial pain
Measured using a self reported facial pain visual analogue scale using a 100-mm long line with each end marked with "None possible" on the left, and "Worst" on the right. Participants will identify their pain level by indicating a point on the line between each end. The point will be measured from the "None possible" end and the number of millimters will be reported as the pain score.
Change in Brief Pain Inventory Short Form
Measured using the Brief Pain Inventory Short Form (BPI-SF). Self reported questionnaire consisting of 12 questions asking participants to rate pain and interference with activity on scales of 0 = no pain/nodes not interfere; 10 = pain as bad as you can image/completely interferes. Total higher scores indicating worse outcome.

Secondary Outcome Measures

Subjects reporting pain with device use
Number of subjects reporting pain with device use
Subjects reporting epistaxis
Number of subjects reporting epistaxis
Change in nasal obstruction symptoms
Measured using the Nasal Obstruction Symptom Evaluation (NOSE) Score. Self reported survey to assess nasal obstruction on quality of life with 5 questions rating how much of a problem a condition was in the past 1 month on a scale of 0=not a problem; 4=severe problem. Total scores possible scores out of 100 and categorized as Mild (range, 5-25), Moderate (range, 30-50), Severe (range, 55-75), Extreme (range, 80-100) nasal obstruction.

Full Information

First Posted
July 27, 2022
Last Updated
April 11, 2023
Sponsor
Mayo Clinic
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1. Study Identification

Unique Protocol Identification Number
NCT05479604
Brief Title
Treatment of Sinus Headache Using a Novel Device That Combines Acoustic Vibration With Oscillating Expiratory Pressure
Official Title
Treatment of Sinus Headache Using a Novel Device That Combines Acoustic Vibration With Oscillating Expiratory Pressure: Randomized Controlled Trial
Study Type
Interventional

2. Study Status

Record Verification Date
April 2023
Overall Recruitment Status
Recruiting
Study Start Date
March 22, 2023 (Actual)
Primary Completion Date
December 2023 (Anticipated)
Study Completion Date
December 2023 (Anticipated)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Mayo Clinic

4. Oversight

Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
Yes
Data Monitoring Committee
No

5. Study Description

Brief Summary
The purpose of this study is to investigate if the SinuSonic device decreases facial pain and pressure compared to the placebo device.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Facial Pain
Keywords
Facial Pressure

7. Study Design

Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
ParticipantInvestigator
Allocation
Randomized
Enrollment
99 (Anticipated)

8. Arms, Groups, and Interventions

Arm Title
SinuSonic Group
Arm Type
Experimental
Arm Description
Subjects will use the SinuSonic device for 2 minutes twice daily for 8 weeks
Arm Title
Sham Group
Arm Type
Sham Comparator
Arm Description
Subjects will use the sham device for 2 minutes twice daily for 8 weeks
Intervention Type
Device
Intervention Name(s)
SinuSonic
Intervention Description
Handheld device that utilizes sound and pressure combined with normal breathing to relieve nasal congestion. The device is held over the nose and creates vibrations similar to humming.
Intervention Type
Device
Intervention Name(s)
Sham Device
Intervention Description
Device looks exactly like study device but does not emit the same pressure or make the same noise as the study device
Primary Outcome Measure Information:
Title
Change in facial pain
Description
Measured using a self reported facial pain visual analogue scale using a 100-mm long line with each end marked with "None possible" on the left, and "Worst" on the right. Participants will identify their pain level by indicating a point on the line between each end. The point will be measured from the "None possible" end and the number of millimters will be reported as the pain score.
Time Frame
Baseline, 8 weeks
Title
Change in Brief Pain Inventory Short Form
Description
Measured using the Brief Pain Inventory Short Form (BPI-SF). Self reported questionnaire consisting of 12 questions asking participants to rate pain and interference with activity on scales of 0 = no pain/nodes not interfere; 10 = pain as bad as you can image/completely interferes. Total higher scores indicating worse outcome.
Time Frame
Baseline, 8 weeks
Secondary Outcome Measure Information:
Title
Subjects reporting pain with device use
Description
Number of subjects reporting pain with device use
Time Frame
8 weeks
Title
Subjects reporting epistaxis
Description
Number of subjects reporting epistaxis
Time Frame
8 weeks
Title
Change in nasal obstruction symptoms
Description
Measured using the Nasal Obstruction Symptom Evaluation (NOSE) Score. Self reported survey to assess nasal obstruction on quality of life with 5 questions rating how much of a problem a condition was in the past 1 month on a scale of 0=not a problem; 4=severe problem. Total scores possible scores out of 100 and categorized as Mild (range, 5-25), Moderate (range, 30-50), Severe (range, 55-75), Extreme (range, 80-100) nasal obstruction.
Time Frame
Baseline, 8 weeks

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
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.
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Amar Miglani, MD
Organizational Affiliation
Mayo Clinic
Official's Role
Principal Investigator
Facility Information:
Facility Name
Mayo Clinic Arizona
City
Phoenix
State/Province
Arizona
ZIP/Postal Code
85054
Country
United States
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Tia Wilkes
Phone
904-953-0816
Email
curesathome@mayo.edu
Facility Name
Mayo Clinic Florida
City
Jacksonville
State/Province
Florida
ZIP/Postal Code
32224
Country
United States
Individual Site Status
Not yet recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Tia Wilkes
Phone
904-953-0816
Email
curesathome@mayo.edu

12. IPD Sharing Statement

Links:
URL
https://www.mayo.edu/research/clinical-trials
Description
Mayo Clinic Clinical Trials

Learn more about this trial

Treatment of Sinus Headache Using a Novel Device That Combines Acoustic Vibration With Oscillating Expiratory Pressure

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