Trial Outcomes & Findings for Effects of SinuSonic on Psychological and Physical Well-Being (NCT NCT06268730)

Last Updated: 2026-01-08

Results Overview

The Anxiety Subscale of the Hospital Anxiety and Depression Scale (HADS) is a 7-item self-report questionnaire measuring the frequency of anxiety over the prior week. The anxiety subscale ranges from 0 to 21, with higher scores indicating higher anxiety complaints. Repeated measures ANOVA will be used to evaluate significant differences in change scores using a 0.05 significance level.

Recruitment status

TERMINATED

Study phase

Target enrollment

16 participants

Primary outcome timeframe

Baseline, 5 weeks

Results posted on

2026-01-08

Participant Flow

Of the 16 participants who signed informed consent and were enrolled, 4 did not complete any data collection or receive exposure to the study intervention. Twelve participants completed Baseline assessment.

Participant milestones

Participant milestones
Measure	SinuSonic Participants are asked to use the SinuSonic twice daily for 5 consecutive weeks. The duration of each use is 2 minutes. SinuSonic: The SinuSonic is a commercially available, over-the-counter, self-applied nasal device designed to enhance physical well-being by reducing nasal congestion via simultaneous administration of acoustic vibration and gentle oscillating expiratory pressure.
Overall Study STARTED	16
Overall Study Completed Baseline	12
Overall Study Completed 5 Weeks	7
Overall Study COMPLETED	7
Overall Study NOT COMPLETED	9

Reasons for withdrawal

Withdrawal data not reported

Baseline Characteristics

Effects of SinuSonic on Psychological and Physical Well-Being

Baseline characteristics by cohort

Baseline characteristics by cohort
Measure	SinuSonic n=12 Participants Participants are asked to use the SinuSonic twice daily for 5 consecutive weeks. The duration of each use is 2 minutes. SinuSonic: The SinuSonic is a commercially available, over-the-counter, self-applied nasal device designed to enhance physical well-being by reducing nasal congestion via simultaneous administration of acoustic vibration and gentle oscillating expiratory pressure.
Age, Categorical <=18 years	0 Participants n=18 Participants
Age, Categorical Between 18 and 65 years	12 Participants n=18 Participants
Age, Categorical >=65 years	0 Participants n=18 Participants
Sex/Gender, Customized Female	5 Participants n=18 Participants
Sex/Gender, Customized Male	6 Participants n=18 Participants
Sex/Gender, Customized Chose not to answer	1 Participants n=18 Participants
Ethnicity (NIH/OMB) Hispanic or Latino	1 Participants n=18 Participants
Ethnicity (NIH/OMB) Not Hispanic or Latino	10 Participants n=18 Participants
Ethnicity (NIH/OMB) Unknown or Not Reported	1 Participants n=18 Participants
Race (NIH/OMB) American Indian or Alaska Native	0 Participants n=18 Participants
Race (NIH/OMB) Asian	0 Participants n=18 Participants
Race (NIH/OMB) Native Hawaiian or Other Pacific Islander	0 Participants n=18 Participants
Race (NIH/OMB) Black or African American	0 Participants n=18 Participants
Race (NIH/OMB) White	11 Participants n=18 Participants
Race (NIH/OMB) More than one race	1 Participants n=18 Participants
Race (NIH/OMB) Unknown or Not Reported	0 Participants n=18 Participants
Region of Enrollment United States	12 Participants n=18 Participants

PRIMARY outcome

Timeframe: Baseline, 5 weeks

Outcome measures

Outcome measures
Measure	SinuSonic n=7 Participants Participants are asked to use the SinuSonic twice daily for 5 consecutive weeks. The duration of each use is 2 minutes. SinuSonic: The SinuSonic is a commercially available, over-the-counter, self-applied nasal device designed to enhance physical well-being by reducing nasal congestion via simultaneous administration of acoustic vibration and gentle oscillating expiratory pressure.
Change in the Anxiety Subscale of the Hospital Anxiety and Depression Scale	-2.57 score on a scale Standard Deviation 1.24

PRIMARY outcome

Timeframe: Baseline, 5 weeks

The Depression Subscale of the Hospital Anxiety and Depression Scale (HADS) is a 7-item self-report questionnaire measuring the frequency of depression over the prior week. The depression subscale ranges from 0 to 21, with higher scores indicating higher depression complaints. Repeated measures ANOVA will be used to evaluate significant differences in change scores using a 0.05 significance level.

Outcome measures

Outcome measures
Measure	SinuSonic n=7 Participants Participants are asked to use the SinuSonic twice daily for 5 consecutive weeks. The duration of each use is 2 minutes. SinuSonic: The SinuSonic is a commercially available, over-the-counter, self-applied nasal device designed to enhance physical well-being by reducing nasal congestion via simultaneous administration of acoustic vibration and gentle oscillating expiratory pressure.
Change in the Depression Subscale of the Hospital Anxiety and Depression Scale	-2.86 score on a scale Standard Deviation 1.25

SECONDARY outcome

Timeframe: Baseline, 5 weeks

Body Perception Questionnaire (BPQ) is a self-report questionnaire, which includes a 20-item subscale for Autonomic Nervous System Reactivity. Only the Autonomic Nervous System Reactivity subscale will be administered. Raw scores range from 0-100, with higher scores indicating greater level of symptoms associated with autonomic activity (poorer outcome). Repeated measures ANOVA will be used to evaluate significant differences in change scores using a 0.05 significance level.

Outcome measures

Outcome measures
Measure	SinuSonic n=7 Participants Participants are asked to use the SinuSonic twice daily for 5 consecutive weeks. The duration of each use is 2 minutes. SinuSonic: The SinuSonic is a commercially available, over-the-counter, self-applied nasal device designed to enhance physical well-being by reducing nasal congestion via simultaneous administration of acoustic vibration and gentle oscillating expiratory pressure.
Change in the Body Perception Questionnaire	-5.43 score on a scale Standard Deviation 2.49

SECONDARY outcome

Timeframe: Baseline, 5 weeks

Population: Data are not reported for one participant who did not complete the initial questionaire.

Total Nasal Symptom Score (TNSS) is a 4-item self-report measure of congestion symptom severity. 0 indicates no symptoms, a score of 1 for mild symptoms that are easily tolerated, 2 for awareness of symptoms which are bothersome but tolerable and 3 is reserved for severe symptoms that are hard to tolerate and interfere with daily activity. TNSS is calculated by adding the score for each of the symptoms to a total out of 12. Repeated measures ANOVA will be used to evaluate significant differences in change scores using a 0.05 significance level.

Outcome measures

Outcome measures
Measure	SinuSonic n=6 Participants Participants are asked to use the SinuSonic twice daily for 5 consecutive weeks. The duration of each use is 2 minutes. SinuSonic: The SinuSonic is a commercially available, over-the-counter, self-applied nasal device designed to enhance physical well-being by reducing nasal congestion via simultaneous administration of acoustic vibration and gentle oscillating expiratory pressure.
Change in the Total Nasal Symptom Score	-3.67 score on a scale Standard Deviation 1.04

SECONDARY outcome

Timeframe: Week 1, Week 5

Population: Data are not reported for one participant who did not complete the Week 1 questionaire.

The Patient Global Impression of Change (PGIC) is a 1-item self-report measure to rate the level of change that participants have experienced. The PGIC scale ranges from 1 to 7, with 1 indicating no change and 7 signifying a substantial improvement. Repeated measures ANOVA will be used to evaluate significant differences in change scores using a 0.05 significance level.

Outcome measures

Outcome measures
Measure	SinuSonic n=6 Participants Participants are asked to use the SinuSonic twice daily for 5 consecutive weeks. The duration of each use is 2 minutes. SinuSonic: The SinuSonic is a commercially available, over-the-counter, self-applied nasal device designed to enhance physical well-being by reducing nasal congestion via simultaneous administration of acoustic vibration and gentle oscillating expiratory pressure.
Change in the Patient Global Impression of Change	0.50 score on a scale Standard Deviation 0.87

SECONDARY outcome

Timeframe: Baseline

Population: All collected data are reported although some participants opted not to complete all of the initial Baseline questionaires.

The Adverse Traumatic Experiences Survey (ATES) is a 30-item self-report measure with items relating to childhood adverse experiences, childhood maltreatment, other person maltreatment, life-threatening situations, sudden deaths of close ones, and personal health situations. Respondent-reported prior adverse events of maltreatment, life-threatening situations, and sudden deaths of close ones are summed to create an adversity score (range: 0-80), with higher scores indicating more adversity. Pearson correlational analysis will enable evaluation of the relationships between ATES and other Baseline outcome variables.

Outcome measures

Outcome measures
Measure	SinuSonic n=11 Participants Participants are asked to use the SinuSonic twice daily for 5 consecutive weeks. The duration of each use is 2 minutes. SinuSonic: The SinuSonic is a commercially available, over-the-counter, self-applied nasal device designed to enhance physical well-being by reducing nasal congestion via simultaneous administration of acoustic vibration and gentle oscillating expiratory pressure.
Adverse Traumatic Experiences Survey at Baseline ATES with SF20	-0.39 correlation coefficient
Adverse Traumatic Experiences Survey at Baseline ATES with BPQ	0.332 correlation coefficient
Adverse Traumatic Experiences Survey at Baseline ATES with HADS-Anxiety	0.543 correlation coefficient
Adverse Traumatic Experiences Survey at Baseline ATES with HADS-Depression	0.492 correlation coefficient
Adverse Traumatic Experiences Survey at Baseline ATES with TNSS	-.002 correlation coefficient

SECONDARY outcome

Timeframe: Baseline

Population: All collected data are reported although some participants opted not to complete all of the initial Baseline questionaires.

The 20-Item Short Form Survey (SF-20) is a shortened form of the original 36-item questionnaire created for the Medical Outcomes Study. The SF-20 utilizes close-ended, Likert-type questions to address self-reported health-related quality of life within six domains: physical functioning, role functioning, social functioning, mental health, current health perceptions, and pain. Raw scores from the 20 items are transformed linearly into 0-100 scales for each of the six domains. Higher scores indicate better physical, role, and social functioning, better mental health and health perceptions, and more pain. Scores across domains will be used to generate a general health status measure. Pearson correlational analysis will enable evaluation of the relationships between SF-20 and other Baseline outcome variables.

Outcome measures

Outcome measures
Measure	SinuSonic n=9 Participants Participants are asked to use the SinuSonic twice daily for 5 consecutive weeks. The duration of each use is 2 minutes. SinuSonic: The SinuSonic is a commercially available, over-the-counter, self-applied nasal device designed to enhance physical well-being by reducing nasal congestion via simultaneous administration of acoustic vibration and gentle oscillating expiratory pressure.
Short Form Health Survey (SF-20) at Baseline SF-20 with ATES	-0.39 correlation coefficient
Short Form Health Survey (SF-20) at Baseline SF-20 with BPQ	-0.66 correlation coefficient
Short Form Health Survey (SF-20) at Baseline SF-20 with HADS-Anxiety	-0.63 correlation coefficient
Short Form Health Survey (SF-20) at Baseline SF-20 with HADS-Depression	-0.59 correlation coefficient
Short Form Health Survey (SF-20) at Baseline SF-20 with TNSS	-.38 correlation coefficient

Adverse Events

SinuSonic

Serious events: 0 serious events

Other events: 0 other events

Deaths: 0 deaths

Serious adverse events

Adverse event data not reported

Other adverse events

Adverse event data not reported

Additional Information

Keri Heilman, PhD

University of North Carolina at Chapel Hill

Phone: 913-802-2168

Email: [email protected]

Results disclosure agreements

Principal investigator is a sponsor employee
Publication restrictions are in place