Sleep Apnea
Conditions
Brief summary
Prospective, open-label, randomized crossover assignment, multi-center non-inferiority study conducted in the United States
Detailed description
This study is designed to demonstrate that the FRESCA Airbox Positive Airway Pressure System is non-inferior to the existing FRESCA Positive Airway Pressure System. Subjects meeting the inclusion and exclusion criteria will be randomized to one sleep night with the existing FRESCA device programmed to fixed pressure and one sleep night with the investigational FRESCA device programmed to auto-adjusting pressure and exhale pressure relief.
Interventions
DEVICEpositive airway pressure system
Positive Airway Pressure System
Sponsors
FRESCA Medical
Study design
Allocation
RANDOMIZED
Intervention model
CROSSOVER
Primary purpose
TREATMENT
Masking
SINGLE (Outcomes Assessor)
Masking description
Central sleep study scorer will be masked to assignment group
Intervention model description
Prospective, open-label, randomized crossover assignment, multi-center study conducted in the United States
Eligibility
Sex/Gender
ALL
Age
22 Years to 75 Years
Healthy volunteers
No
Inclusion criteria
1. Male or female aged 22 - 75 years old. 2. BMI: ≤ 40 kg/m2. 3. Subjects diagnosed with OSA (either newly diagnosed (naive) OSA subjects or current CPAP subjects). 4. Must be able to be fitted properly with FRESCA mask. 5. Must be able to comply with all study requirements as outlined in the protocol. 6. Subject must complete a valid PSG titration night.
Exclusion criteria
1. Subjects with non-OSA sleep disorders (including periodic limb movement (PLM) disorder and chronic insomnia). 2. Subjects with substantial central or mixed apneas (central and mixed apnea ≥ 5/hr.). 3. Subjects with prior surgical intervention for OSA. 4. Subjects with frequent or sustained episodes of O2 saturation ≤75%. 5. Subjects with obesity-related hypoventilation. 6. Subjects currently using a CPAP full face mask. 7. Subjects who are medically unstable. 8. Subjects with unstable or severe cardiovascular abnormalities (e.g., heart failure, valvular heart disease). 9. Subjects with atrial fibrillation or other arrhythmias that are not effectively controlled with medication. 10. Subjects with hypotension or uncontrolled HTN. 11. Subjects with chronic lung disease, including COPD. 12. Subjects with significant cardiopulmonary disease. 13. Subjects with ongoing severe nasal allergies or sinusitis or difficulty breathing through the nose; persistent blockage of one or both nostrils; or any nasal or facial abnormalities that would not allow adequate placement and use of the mask. 14. Subjects with surgery of the upper airway, nose, sinus or middle ear within the previous year. 15. Subjects currently working nights, rotating night shifts or with planned travel during the study period. 16. Subjects on a non-stable dose of medications or other agents that may affect sleep and/or PSG (e.g., sedatives or hypnotics). 17. Subjects who consume \> 500 mg caffeine per day (e.g., \> 8 cola-type beverages, \> 5 cups of coffee). 18. Subjects who consume \> 14 alcoholic drinks/week. 19. Subjects who are pregnant (confirmed verbally). 20. Subjects currently enrolled in any other research study.
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Apnea-Hypopnea Index (AHI) | 1 sleep night | The mean combined number of apnea and hypopnea events per hour of sleep |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Oxygen Desaturation Index (ODI) | 1 sleep night | The number of oxygen desaturations ≥ 4% per hour of sleep |
Countries
United States
Participant flow
Recruitment details
75 subjects were screened for eligibility
Pre-assignment details
52 subjects were enrolled and randomized.
Participants by arm
| Arm | Count |
|---|---|
| All Study Participants All study participants | 52 |
| Total | 52 |
Baseline characteristics
| Characteristic | All Study Participants |
|---|---|
| Age, Continuous | 54.5 years STANDARD_DEVIATION 10.87 |
| BMI | 32.69 kg/m2 STANDARD_DEVIATION 4.195 |
| Diastolic blood pressure | 75.74 mmHg STANDARD_DEVIATION 8.267 |
| Ethnicity (NIH/OMB) Hispanic or Latino | 3 Participants |
| Ethnicity (NIH/OMB) Not Hispanic or Latino | 49 Participants |
| Ethnicity (NIH/OMB) Unknown or Not Reported | 0 Participants |
| Heart Rate | 72.74 bpm STANDARD_DEVIATION 11.133 |
| Height | 67.70 in STANDARD_DEVIATION 3.729 |
| Oral Temperature | 97.87 degrees F STANDARD_DEVIATION 0.513 |
| Race (NIH/OMB) American Indian or Alaska Native | 0 Participants |
| Race (NIH/OMB) Asian | 0 Participants |
| Race (NIH/OMB) Black or African American | 13 Participants |
| Race (NIH/OMB) More than one race | 0 Participants |
| Race (NIH/OMB) Native Hawaiian or Other Pacific Islander | 0 Participants |
| Race (NIH/OMB) Unknown or Not Reported | 0 Participants |
| Race (NIH/OMB) White | 39 Participants |
| Sex: Female, Male Female | 21 Participants |
| Sex: Female, Male Male | 31 Participants |
| Systolic blood pressure | 123.26 mmHg STANDARD_DEVIATION 13.74 |
| Weight | 213.98 lbs STANDARD_DEVIATION 36.833 |
Adverse events
| Event type | EG000 affected / at risk | EG001 affected / at risk |
|---|---|---|
| deaths Total, all-cause mortality | 0 / 52 | 0 / 52 |
| other Total, other adverse events | 4 / 52 | 6 / 52 |
| serious Total, serious adverse events | 0 / 52 | 0 / 52 |
Outcome results
Primary
Apnea-Hypopnea Index (AHI)
The mean combined number of apnea and hypopnea events per hour of sleep
Time frame: 1 sleep night
Population: All participants who completed two valid sleep nights were included in the efficacy analysis
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| FRESCA Flow Generator | Apnea-Hypopnea Index (AHI) | 3.20 events/hr | Standard Deviation 8.62 |
| FRESCA Airbox Flow Generator | Apnea-Hypopnea Index (AHI) | 4.86 events/hr | Standard Deviation 10.047 |
Secondary
Oxygen Desaturation Index (ODI)
The number of oxygen desaturations ≥ 4% per hour of sleep
Time frame: 1 sleep night
Population: All participants who completed two valid sleep nights were included in the efficacy analysis
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| FRESCA Flow Generator | Oxygen Desaturation Index (ODI) | 3.12 events/hr | Standard Deviation 9.274 |
| FRESCA Airbox Flow Generator | Oxygen Desaturation Index (ODI) | 4.69 events/hr | Standard Deviation 10.425 |