Trial Outcomes & Findings for Non-Inferiority Study of the FRESCA Airbox Positive Airway Pressure System (NCT NCT03999944)
NCT ID: NCT03999944
Last Updated: 2021-06-23
Results Overview
The mean combined number of apnea and hypopnea events per hour of sleep
Recruitment status
COMPLETED
Study phase
NA
Target enrollment
52 participants
Primary outcome timeframe
1 sleep night
Results posted on
2021-06-23
Participant Flow
75 subjects were screened for eligibility
52 subjects were enrolled and randomized.
Participant milestones
| Measure |
Sequence 1 (FRESCA Flow Generator Then FRESCA Airbox Flow Generator)
Subject first used FRESCA Flow Generator during in-lab sleep night, then used the FRESCA Airbox Flow Generator during in-lab sleep night between 0 - 14 days later.
|
Sequence 2 (FRESCA Airbox Flow Generator, Then FRESCA Flow Generator)
Subject first used FRESCA Airbox Flow Generator during in-lab sleep night, then used the FRESCA Flow Generator during in-lab sleep night between 0 - 14 days later.
|
|---|---|---|
|
First Sleep Night
STARTED
|
26
|
26
|
|
First Sleep Night
COMPLETED
|
22
|
24
|
|
First Sleep Night
NOT COMPLETED
|
4
|
2
|
|
Second Sleep Night
STARTED
|
22
|
24
|
|
Second Sleep Night
COMPLETED
|
22
|
20
|
|
Second Sleep Night
NOT COMPLETED
|
0
|
4
|
Reasons for withdrawal
Withdrawal data not reported
Baseline Characteristics
Non-Inferiority Study of the FRESCA Airbox Positive Airway Pressure System
Baseline characteristics by cohort
| Measure |
All Study Participants
n=52 Participants
All study participants
|
|---|---|
|
Age, Continuous
|
54.5 years
STANDARD_DEVIATION 10.87 • n=5 Participants
|
|
Sex: Female, Male
Female
|
21 Participants
n=5 Participants
|
|
Sex: Female, Male
Male
|
31 Participants
n=5 Participants
|
|
Ethnicity (NIH/OMB)
Hispanic or Latino
|
3 Participants
n=5 Participants
|
|
Ethnicity (NIH/OMB)
Not Hispanic or Latino
|
49 Participants
n=5 Participants
|
|
Ethnicity (NIH/OMB)
Unknown or Not Reported
|
0 Participants
n=5 Participants
|
|
Race (NIH/OMB)
American Indian or Alaska Native
|
0 Participants
n=5 Participants
|
|
Race (NIH/OMB)
Asian
|
0 Participants
n=5 Participants
|
|
Race (NIH/OMB)
Native Hawaiian or Other Pacific Islander
|
0 Participants
n=5 Participants
|
|
Race (NIH/OMB)
Black or African American
|
13 Participants
n=5 Participants
|
|
Race (NIH/OMB)
White
|
39 Participants
n=5 Participants
|
|
Race (NIH/OMB)
More than one race
|
0 Participants
n=5 Participants
|
|
Race (NIH/OMB)
Unknown or Not Reported
|
0 Participants
n=5 Participants
|
|
Height
|
67.70 in
STANDARD_DEVIATION 3.729 • n=5 Participants
|
|
Weight
|
213.98 lbs
STANDARD_DEVIATION 36.833 • n=5 Participants
|
|
BMI
|
32.69 kg/m2
STANDARD_DEVIATION 4.195 • n=5 Participants
|
|
Systolic blood pressure
|
123.26 mmHg
STANDARD_DEVIATION 13.740 • n=5 Participants
|
|
Diastolic blood pressure
|
75.74 mmHg
STANDARD_DEVIATION 8.267 • n=5 Participants
|
|
Heart Rate
|
72.74 bpm
STANDARD_DEVIATION 11.133 • n=5 Participants
|
|
Oral Temperature
|
97.87 degrees F
STANDARD_DEVIATION 0.513 • n=5 Participants
|
PRIMARY outcome
Timeframe: 1 sleep nightPopulation: All participants who completed two valid sleep nights were included in the efficacy analysis
The mean combined number of apnea and hypopnea events per hour of sleep
Outcome measures
| Measure |
FRESCA Flow Generator
n=42 Participants
Participants used the FRESCA Flow Generator on either the first or second sleep night.
|
FRESCA Airbox Flow Generator
n=42 Participants
Participants used the FRESCA Airbox Flow Generator on either the first or second sleep night.
|
|---|---|---|
|
Apnea-Hypopnea Index (AHI)
|
3.20 events/hr
Standard Deviation 8.620
|
4.86 events/hr
Standard Deviation 10.047
|
SECONDARY outcome
Timeframe: 1 sleep nightPopulation: All participants who completed two valid sleep nights were included in the efficacy analysis
The number of oxygen desaturations ≥ 4% per hour of sleep
Outcome measures
| Measure |
FRESCA Flow Generator
n=42 Participants
Participants used the FRESCA Flow Generator on either the first or second sleep night.
|
FRESCA Airbox Flow Generator
n=42 Participants
Participants used the FRESCA Airbox Flow Generator on either the first or second sleep night.
|
|---|---|---|
|
Oxygen Desaturation Index (ODI)
|
3.12 events/hr
Standard Deviation 9.274
|
4.69 events/hr
Standard Deviation 10.425
|
Adverse Events
FRESCA Flow Generator
Serious events: 0 serious events
Other events: 4 other events
Deaths: 0 deaths
FRESCA Airbox Flow Generator
Serious events: 0 serious events
Other events: 6 other events
Deaths: 0 deaths
Serious adverse events
Adverse event data not reported
Other adverse events
| Measure |
FRESCA Flow Generator
n=52 participants at risk
Existing FRESCA device programmed to deliver fixed pressure.
positive airway pressure system: Positive Airway Pressure System
|
FRESCA Airbox Flow Generator
n=52 participants at risk
Investigational FRESCA device programmed to deliver auto-adjusting pressure
positive airway pressure system: Positive Airway Pressure System
|
|---|---|---|
|
General disorders
difficulty breathing
|
3.8%
2/52 • Number of events 2 • 2 weeks
52 intent to treat subjects were included in the safety analysis.
|
5.8%
3/52 • Number of events 3 • 2 weeks
52 intent to treat subjects were included in the safety analysis.
|
|
Skin and subcutaneous tissue disorders
skin/nose irritation
|
3.8%
2/52 • Number of events 2 • 2 weeks
52 intent to treat subjects were included in the safety analysis.
|
5.8%
3/52 • Number of events 3 • 2 weeks
52 intent to treat subjects were included in the safety analysis.
|
|
General disorders
difficulty sleeping
|
0.00%
0/52 • 2 weeks
52 intent to treat subjects were included in the safety analysis.
|
1.9%
1/52 • Number of events 1 • 2 weeks
52 intent to treat subjects were included in the safety analysis.
|
|
General disorders
discomfort from headgear
|
0.00%
0/52 • 2 weeks
52 intent to treat subjects were included in the safety analysis.
|
1.9%
1/52 • Number of events 1 • 2 weeks
52 intent to treat subjects were included in the safety analysis.
|
|
Psychiatric disorders
dreaming of suffocating
|
0.00%
0/52 • 2 weeks
52 intent to treat subjects were included in the safety analysis.
|
1.9%
1/52 • Number of events 1 • 2 weeks
52 intent to treat subjects were included in the safety analysis.
|
|
Nervous system disorders
headache
|
0.00%
0/52 • 2 weeks
52 intent to treat subjects were included in the safety analysis.
|
1.9%
1/52 • Number of events 1 • 2 weeks
52 intent to treat subjects were included in the safety analysis.
|
|
General disorders
increased effort with inhalation and exhalation
|
1.9%
1/52 • Number of events 1 • 2 weeks
52 intent to treat subjects were included in the safety analysis.
|
1.9%
1/52 • Number of events 1 • 2 weeks
52 intent to treat subjects were included in the safety analysis.
|
|
Respiratory, thoracic and mediastinal disorders
intermittent pain to nose
|
1.9%
1/52 • Number of events 1 • 2 weeks
52 intent to treat subjects were included in the safety analysis.
|
1.9%
1/52 • Number of events 1 • 2 weeks
52 intent to treat subjects were included in the safety analysis.
|
|
Respiratory, thoracic and mediastinal disorders
sore throat
|
0.00%
0/52 • 2 weeks
52 intent to treat subjects were included in the safety analysis.
|
1.9%
1/52 • Number of events 1 • 2 weeks
52 intent to treat subjects were included in the safety analysis.
|
Additional Information
Results disclosure agreements
- Principal investigator is a sponsor employee
- Publication restrictions are in place