Trial Outcomes & Findings for A New Treatment for Mechanical Nasal Obstruction (NCT NCT03456115)

Results Overview

PNIF will be measured using a PNIF meter. PNIF will be measured without any device in place and once during the fitting of each device. Flow is measured in liters per minute. Minimum value of -50, maximum value of 150 with higher scores indicating improved airflow.

Recruitment status

COMPLETED

Study phase

NA

Target enrollment

36 participants

Primary outcome timeframe

Prior to device and after fitting each device (Up to 5 minutes)

Results posted on

2023-07-18

Participant Flow

Participant milestones

Participant milestones
Measure	All Participants All participants will be trialing the 5 devices and reporting their thoughts on comfort, and perception of symptoms of mechanical nasal obstruction by way of survey completion. The devices include 4 commercially available nasal dilators: Breathe Right, Max Air, Sleep Right, Nozovent, and the study team's investigational device dubbed the Schnozzle.
Overall Study STARTED	36
Overall Study COMPLETED	36
Overall Study NOT COMPLETED	0

Reasons for withdrawal

Withdrawal data not reported

Baseline Characteristics

A New Treatment for Mechanical Nasal Obstruction

Baseline characteristics by cohort

Baseline characteristics by cohort
Measure	Mechanical Nasal Dilator n=36 Participants All participants will be trialing the 5 devices and reporting their thoughts on comfort, and perception of symptoms of mechanical nasal obstruction by way of survey completion. The devices include 4 commercially available nasal dilators: Breathe Right, Max Air, Sleep Right, Nozovent, and the study team's investigational device dubbed the Schnozzle. Mechanical nasal dilator: Participants will be asked to trial 5 different mechanical nasal dilators. 4 of which are commercially available and one of which is the investigational device being studied for feasibility. The 4 commercially available nasal dilators include Breathe Right, Max Air, Sleep Right, Nozovent. The fifth device is the study team's investigational device dubbed the Schnozzle.
Age, Categorical <=18 years	1 Participants n=93 Participants
Age, Categorical Between 18 and 65 years	29 Participants n=93 Participants
Age, Categorical >=65 years	6 Participants n=93 Participants
Age, Continuous	52 years n=93 Participants
Sex: Female, Male Female	22 Participants n=93 Participants
Sex: Female, Male Male	14 Participants n=93 Participants
Ethnicity (NIH/OMB) Hispanic or Latino	0 Participants n=93 Participants
Ethnicity (NIH/OMB) Not Hispanic or Latino	21 Participants n=93 Participants
Ethnicity (NIH/OMB) Unknown or Not Reported	15 Participants n=93 Participants
Region of Enrollment United States	36 Participants n=93 Participants

PRIMARY outcome

Timeframe: Prior to device and after fitting each device (Up to 5 minutes)

Population: Same participants are showed in all arms because they received all interventions.

PNIF will be measured using a PNIF meter. PNIF will be measured without any device in place and once during the fitting of each device. Flow is measured in liters per minute. Minimum value of -50, maximum value of 150 with higher scores indicating improved airflow.

Outcome measures

Outcome measures
Measure	Breathe Right n=36 Participants Breathe Right dilator	Max Air n=36 Participants Max Air nose cones	Sleep Right n=36 Participants Sleep Right dilator	Mute n=36 Participants Mute dilator	Nozovent n=36 Participants Nozovent dilator	Schnozzle n=36 Participants Schnozzle dilator aka Hale
Change in Peak Nasal Inspiratory Flow (PNIF)	28 liters per minute Standard Deviation 42	24 liters per minute Standard Deviation 38	13 liters per minute Standard Deviation 20	27 liters per minute Standard Deviation 47	25 liters per minute Standard Deviation 35	29 liters per minute Standard Deviation 40

SECONDARY outcome

Timeframe: Baseline

Population: Nasal Obstruction and Septoplasty Effectiveness Scale (NOSE) was not captured on patients. Data was not collected.

The Nasal Obstruction and Septoplasty Effectiveness Scale (NOSE) aims to quantify symptoms of mechanical nasal obstruction. The NOSE metric has a scoring range go 0-100 with 0 being no symptoms of mechanical nasal obstruction and 100 being severe nasal obstruction. Each device is trialed for one day, hence the scale will be administered at Baseline and after a 24-hour trial of each of the 5 devices.

Outcome measures

Outcome data not reported

SECONDARY outcome

Timeframe: 24-hour after trial of each device

Population: Nasal Obstruction and Septoplasty Effectiveness Scale (NOSE) was not captured on patients. Data was not collected.

The Nasal Obstruction and Septoplasty Effectiveness Scale (NOSE) aims to quantify symptoms of mechanical nasal obstruction. The NOSE metric has a scoring range go 0-100 with 0 being no symptoms of mechanical nasal obstruction and 100 being severe nasal obstruction. Each device is trialed for one day, hence the scale will be administered at Baseline and after a 24-hour trial of each of the 5 devices.

Outcome measures

Outcome data not reported

SECONDARY outcome

Timeframe: Up to 5 days

Population: Same participants are showed in all arms because they received all interventions.

Participants will be asked to rank their preferred device form 1 (most preferred) to 5 (least preferred). The mean will be reported. Scores range from 1-5, with 1 being the most preferred.