Trial Outcomes & Findings for A User Study of the Soniflow System for Nasal Congestion Relief (NCT NCT04910139)

Last Updated: 2023-10-12

Results Overview

TNSS is a measure of nasal congestion, measured as the sum of four symptom scores for rhinorrhea, nasal congestion, nasal itching, and sneezing (using a scale of 0=None, 1=Mild, 2=Moderate, or 3=Severe). The minimum TNSS value is 0. The maximum TNSS value is 12. Lower TNSS score means a better outcome

Recruitment status

COMPLETED

Study phase

Target enrollment

50 participants

Primary outcome timeframe

20 minutes

Results posted on

2023-10-12

Participant Flow

Participant milestones

Participant milestones
Measure	Treatment Treatment using acoustic energy Soniflow System: Treatment using acoustic vibrational headband worn circumferentially at the level of the forehead paired with a Smartphone App.
Overall Study STARTED	50
Overall Study COMPLETED	50
Overall Study NOT COMPLETED	0

Reasons for withdrawal

Withdrawal data not reported

Baseline Characteristics

A User Study of the Soniflow System for Nasal Congestion Relief

Baseline characteristics by cohort

Baseline characteristics by cohort
Measure	Treatment n=50 Participants Treatment using acoustic energy Soniflow System: Treatment using acoustic vibrational headband worn circumferentially at the level of the forehead paired with a Smartphone App.
Age, Categorical Age · <=18 years	0 Participants n=5 Participants
Age, Categorical Age · Between 18 and 65 years	46 Participants n=5 Participants
Age, Categorical Age · >=65 years	4 Participants n=5 Participants
Sex: Female, Male Female	20 Participants n=5 Participants
Sex: Female, Male Male	30 Participants n=5 Participants
Ethnicity (NIH/OMB) Hispanic or Latino	3 Participants n=5 Participants
Ethnicity (NIH/OMB) Not Hispanic or Latino	46 Participants n=5 Participants
Ethnicity (NIH/OMB) Unknown or Not Reported	1 Participants n=5 Participants
Region of Enrollment United States	50 participants n=5 Participants
Total Nasal Symptom Score	4.1 units on a scale n=5 Participants

PRIMARY outcome

Timeframe: 20 minutes

Population: Adult subjects with nasal congestion

Outcome measures

Outcome measures
Measure	Treatment n=50 Participants Treatment using acoustic energy Soniflow System: Treatment using acoustic vibrational headband worn circumferentially at the level of the forehead paired with a Smartphone App.
Total Nasal Symptom Score	2.0 score on a scale Interval 1.6 to 2.5

SECONDARY outcome

Timeframe: 20 minutes

Population: adults with nasal congestion

Visual Analog Scale (VAS) for Headache, using a scale of 0-10. 0 is the minimum and 10 is maximum on this scale. Lower scores mean a better outcome.

Outcome measures

Outcome measures
Measure	Treatment n=50 Participants Treatment using acoustic energy Soniflow System: Treatment using acoustic vibrational headband worn circumferentially at the level of the forehead paired with a Smartphone App.
Visual Analog Scale (VAS) for Headache	0.9 score on a scale of 0-10 Interval 0.4 to 1.5

SECONDARY outcome

Timeframe: 20 minutes

Population: adults with nasal congestion

Visual Analog Scale (VAS) for Facial Pain, using a scale of 0-10. 0 is minimum and 10 is the maximum value for this scale. Lower scores mean a better outcome.

Outcome measures

Outcome measures
Measure	Treatment n=50 Participants Treatment using acoustic energy Soniflow System: Treatment using acoustic vibrational headband worn circumferentially at the level of the forehead paired with a Smartphone App.
Visual Analog Scale (VAS) for Facial Pain	0.9 score on a scale (of 0-10) Interval 0.5 to 1.5

Adverse Events

Treatment

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

Paramesh Gopi

Sound Health Systems

Phone: 408-316-3631

Email: [email protected]

Results disclosure agreements

Principal investigator is a sponsor employee
Publication restrictions are in place