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Behavioural Intervention

SinuSonic for Nasal Congestion

N/A
Recruiting
Led By Keri J Heilman, PhD
Research Sponsored by University of North Carolina, Chapel Hill
Eligibility Criteria Checklist
Specific guidelines that determine who can or cannot participate in a clinical trial
Must have
18 years or older
Currently experiencing symptoms of nasal congestion that have persisted at least 2 weeks. Symptom severity must be rated at least 5, on a visual scale ranging from 1 to 10, as included in a question in the Eligibility Screening.
Must not have
Current or history of circulatory problems (i.e., active nose bleed, heart arrhythmia, coronary artery disease, congestive heart failure, heart attack)
Current or history of breathing problems (i.e., asthma, chronic obstructive pulmonary disorder (COPD), chronic bronchitis, emphysema, pneumonia, pleural effusion, lung cancer, cancer of the throat or upper airway)
Timeline
Screening 3 weeks
Treatment Varies
Follow Up baseline
Awards & highlights
No Placebo-Only Group

Summary

This trial aims to see how using SinuSonic affects the mental and physical well-being of adults with nasal congestion. Participants will report on their health before and after using SinuSonic for

Who is the study for?
This trial is for adults with chronic nasal congestion who want to test a device called SinuSonic. It's designed to see if it can improve their physical and mental well-being. People with ongoing sinus issues, inflammation, or psychological impacts from nasal congestion may qualify.
What is being tested?
The study tests the SinuSonic device on adults with chronic nasal congestion over five weeks. It measures changes in physical health, anxiety, depression, and autonomic reactivity (how the nervous system controls body functions) before and after using the device.
What are the potential side effects?
Potential side effects are not specified but participants will document any adverse experiences weekly while using SinuSonic. This could include discomfort or other negative reactions related to the use of the device.

Eligibility Criteria

Inclusion Criteria

You may be eligible if you check “Yes” for the criteria below
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I am 18 years old or older.
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I have had a blocked nose for over 2 weeks, and it's quite severe.

Exclusion Criteria

You may be eligible for the trial if you check “No” for criteria below:
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I have or had heart or circulation problems.
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I have or had breathing issues like asthma, COPD, or lung cancer.
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I do not have a brain tumor, severe ear pain, or a high fever.

Timeline

Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~baseline, 5 weeks
This trial's timeline: 3 weeks for screening, Varies for treatment, and baseline, 5 weeks for reporting.

Treatment Details

Study Objectives

Study objectives can provide a clearer picture of what you can expect from a treatment.
Primary study objectives
Change in the Anxiety Subscale of the Hospital Anxiety and Depression Scale
Change in the Depression Subscale of the Hospital Anxiety and Depression Scale
Secondary study objectives
Adverse Traumatic Experiences Survey at Baseline
Change in the Body Perception Questionnaire
Change in the Patient Global Impression of Change
+2 more

Awards & Highlights

No Placebo-Only Group
All patients enrolled in this study will receive some form of active treatment.

Trial Design

1Treatment groups
Experimental Treatment
Group I: SinuSonicExperimental Treatment1 Intervention
Participants are asked to use the SinuSonic twice daily for 5 consecutive weeks. The duration of each use is 2 minutes.

Find a Location

Who is running the clinical trial?

University of North Carolina, Chapel HillLead Sponsor
1,557 Previous Clinical Trials
4,298,519 Total Patients Enrolled
Healthy Humming, LLCIndustry Sponsor
Keri J Heilman, PhDPrincipal InvestigatorUniversity of North Carolina, Chapel Hill
5 Previous Clinical Trials
542 Total Patients Enrolled
~15 spots leftby Mar 2025
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