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

Study Results

Results available

Outcome measurements, participant flow, baseline characteristics, and adverse events have been published for this study.

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Basic Information

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Recruitment Status

TERMINATED

Clinical Phase

NA

Total Enrollment

27 participants

Study Classification

INTERVENTIONAL

Study Start Date

2023-03-22

Study Completion Date

2024-06-07

Brief Summary

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

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Detailed Description

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Conditions

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Facial Pain

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

TREATMENT

Blinding Strategy

DOUBLE

Participants Investigators

Study Groups

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SinuSonic Group

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

Group Type EXPERIMENTAL

SinuSonic

Intervention Type DEVICE

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.

Sham Group

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

Group Type SHAM_COMPARATOR

Sham Device

Intervention Type DEVICE

Device looks exactly like study device but does not emit the same pressure or make the same noise as the study device

Interventions

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SinuSonic

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

Sham Device

Device looks exactly like study device but does not emit the same pressure or make the same noise as the study device

Intervention Type DEVICE

Eligibility Criteria

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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 (Visual Analogue Scale) 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.

Minimum Eligible Age

18 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No