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Behavioural Intervention

SinuSonic for Nasal Congestion and Inflammation

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.
Timeline
Screening 3 weeks
Treatment Varies
Follow Up baseline
Awards & highlights

Study 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.Check my eligibility
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.See study design
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
Select...
I am 18 years old or older.
Select...
I have had a blocked nose for over 2 weeks, and it's quite severe.

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

Outcome measures can provide a clearer picture of what you can expect from a treatment.
Primary outcome measures
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 outcome measures
Adverse Traumatic Experiences Survey at Baseline
Change in the Body Perception Questionnaire
Change in the Patient Global Impression of Change
+2 more

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
1,508 Previous Clinical Trials
4,190,775 Total Patients Enrolled
Healthy Humming, LLCIndustry Sponsor
Keri J Heilman, PhDPrincipal InvestigatorUniversity of North Carolina, Chapel Hill
4 Previous Clinical Trials
492 Total Patients Enrolled

Frequently Asked Questions

These questions and answers are submitted by anonymous patients, and have not been verified by our internal team.

What is the primary purpose of conducting this medical study?

"The primary objective of this clinical investigation is to assess the alteration in the Anxiety Subscale score on the Hospital Anxiety and Depression Scale within a 5-week duration starting from Baseline. Secondary endpoints include modifications in the Patient Global Impression of Change scale, which ranges from 1 (indicating no change) to 7 (representing marked improvement). Additionally, changes in Total Nasal Symptom Score will be evaluated based on congestion severity levels ranging from 0 (no symptoms) to 3 (severe symptoms affecting daily activities), with scores summing up to a total out of 12. The Adverse Traumatic Experiences Survey"

Answered by AI

Could individuals above the age of 70 years participate in this trial?

"This investigation seeks individuals over 18 years old but under the age of 99 to participate."

Answered by AI

Do I meet the necessary criteria to participate in this clinical investigation?

"Patients aged between 18 and 99 with nasal congestion, inflammation may be eligible for this research study. The trial aims to enroll approximately 50 participants."

Answered by AI

Is the recruitment for this study still ongoing at present?

"As per clinicaltrials.gov, this particular research endeavor is not currently in search of additional participants. The study was initially listed on April 1st, 2024 and last revised on February 12th, 2024. Although recruitment for this trial has ceased, it's worth noting that there are presently a total of 335 other ongoing studies actively seeking candidates for enrollment."

Answered by AI

Who else is applying?

What site did they apply to?
University of North Carolina at Chapel Hill
What portion of applicants met pre-screening criteria?
Met criteria
Recent research and studies
clinicaltrials.govStudy
Effects of SinuSonic on Psychological and Physical Well-Being
2024. "Effects of SinuSonic on Psychological and Physical Well-Being". ClinicalTrials.gov. https://clinicaltrials.gov/ct2/show/NCT06268730.
All > High Point > Greensboro
~33 spots leftby Jul 2024
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