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Use of Novel Sinusonic Device for Prevention of Community Acquired Upper Respiratory Infection (URI)

NCT ID: NCT04468204

Last Updated: 2022-12-20

Study Results

Results available

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Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

NA

Total Enrollment

95 participants

Study Classification

INTERVENTIONAL

Study Start Date

2020-10-01

Study Completion Date

2021-07-01

Brief Summary

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This study aims to test the safety, efficacy and potential mechanism of action of the SinuSonic device on adults with upper respiratory infection (URI). SinuSonic is a medical device that utilizes sound and pressure combined with normal breathing. The study will have 2 aims. Aim 1 willdetermine if Sinusonic decreases the number of URIs experienced during an 8 week fall URI season. Subjects will use an active device (positive expiratory pressure and 128 Hz) or a sham device (no positive expiratory pressure and 1,000 Hz) for 1 min tid for 8 weeks. Aim 2 will determine if Sinusonic decreases the severity and duration of community acquired viral URIs. Subjects will use active or sham device as above.

Detailed Description

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Conditions

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Upper Respiratory Infection

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

TREATMENT

Blinding Strategy

SINGLE

Participants

Study Groups

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SinuSonic Device

SinuSonic device used for 1 min three times a day for 8 weeks.

Group Type EXPERIMENTAL

SinuSonic Device

Intervention Type DEVICE

A medical device that utilizes sound and pressure combined with normal breathing to relieve nasal congestion.

Sham

Sham SinuSonic device used for 1 min three times a day for 8 weeks.

Group Type SHAM_COMPARATOR

Sham SinuSonic Device

Intervention Type DEVICE

Sham positive expiratory pressure intervention using the SinuSonic Device.

Interventions

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SinuSonic Device

A medical device that utilizes sound and pressure combined with normal breathing to relieve nasal congestion.

Intervention Type DEVICE

Sham SinuSonic Device

Sham positive expiratory pressure intervention using the SinuSonic Device.

Intervention Type DEVICE

Other Intervention Names

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Sham

Eligibility Criteria

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Inclusion Criteria

* Adults 18 years or older with no transient symptoms of any URI or allergies at baseline.

Exclusion Criteria

* Any transient ENT condition that may impact upper airway to include acute sinusitis or otitis.
* Any upper respiratory illness within last 2 weeks
* TSS will be measured at baseline as described above and must be \<9 for inclusion (Eccles etal).
* Topical decongestant use in last week
* Current nasal crusting or history of ulceration or perforation
* History of severe nose bleeding within last 3 months
* Known pregnancy
* Immunosuppressed condition or on immune modulating medications such as prednisone or chemotherapy
* Allergic sensitivity to silicone or any other component of device
* Inability to read and understand English
* Inability to perform treatment due to underlying medical condition
Minimum Eligible Age

18 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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Medical University of South Carolina

OTHER

Sponsor Role lead

Responsible Party

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Shaun A. Nguyen, MD

Professor

Responsibility Role PRINCIPAL_INVESTIGATOR

Locations

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Sinus Center - Medical Univesity of South Carolina

Charleston, South Carolina, United States

Site Status

Countries

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United States

Provided Documents

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Document Type: Study Protocol and Statistical Analysis Plan

View Document

Other Identifiers

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Pro00100980

Identifier Type: -

Identifier Source: org_study_id