Obstructive Sleep Apnea, OSA, Sleep Apnea
Conditions
Brief summary
This will be a prospective study in subjects with Obstructive Sleep Apnea (OSA) to characterize the clinical performance during a single night of therapy with a FRESCA mask compared with a single night of therapy with their existing nasal Continuous Positive Airway Pressure (CPAP) mask.
Detailed description
Obstructive Sleep Apnea (OSA) is a common chronic disorder and the most common of all sleep disorders. OSA can occur in any age group, but prevalence increases between middle and older age. Over the last two decades the prevalence of sleep disordered breathing seems to be increasing in both men and women, likely due to increasing rates of obesity. Relative increases reported are between 14% and 55% depending on the subgroup. For men, the current prevalence estimates of moderate to severe sleep-disordered breathing are 10% for 30 to 49 year-olds and 17% for 50 to 70 year-olds. For women, the corresponding prevalence estimates are 3% and 9%. Common consequences of OSA include daytime sleepiness, extreme daytime fatigue, slow reaction time, moodiness, belligerence and vision problems. OSA is also linked to hypertension, increased cardiovascular morbidity, type 2 diabetes, neurocognitive dysfunction and possibly cancer. The study is a prospective, comparative, open label, randomized crossover assignment, multi-center pivotal study. Up to forty-five (45) subjects will be enrolled. It is desirable to have the subject population distributed across the OSA severity criteria range. The purpose of this study is to demonstrate that the FRESCA mask is non-inferior to a CPAP nasal mask in maintaining AHI and ODI during a single night of PSG assessment.
Interventions
DEVICEFRESCA mask first night
FRESCA nasal mask first night
DEVICECPAP Mask first night
CPAP Nasal Mask first night
Sponsors
FRESCA Medical
Study design
Allocation
RANDOMIZED
Intervention model
CROSSOVER
Primary purpose
TREATMENT
Masking
NONE
Eligibility
Sex/Gender
ALL
Age
18 Years to 70 Years
Healthy volunteers
No
Inclusion criteria
1. Male or Female 18-70 years old; 2. Qualifying diagnostic polysomnography (PSG): Resulting in AHI \> 5/hr of sleep (using conventional lab or home test); 3. Qualifying titration PSG: In lab titration within the past 12 months and therapeutic pressure resulting in Apnea Hypopnea Index (AHI) \< 5/hr; 4. Primary medical diagnosis of OSA/ Hypopnea syndrome and on CPAP treatment \> 1 month; 5. Current user of nasal mask or nasal pillow mask; 6. Have regular usage of their CPAP machine ( at least 4 hrs per night and at least 5 nights per week) confirmed by secure digital (SD) card download; 7. No significant changes in the subject's general health and no change in weight greater than ±10 lbs since titration PSG was performed and CPAP therapy initiated (confirmed from medical records); 8. BMI \< 35 kg/m2; 9. Must be able to be fit properly with FRESCA mask; 10. Must be able to comply with all study requirements as outlined in the protocol; 11. Must be able to understand English and be willing to provide written informed consent.
Exclusion criteria
1. Subjects with non OSA sleep disorders; 2. Substantial central or mixed apneas (Central and Mixed apnea index ≥ 5/hr); 3. Subjects actively using bi-level PAP or require oxygen therapy; 4. Subjects using a full face mask or chin strap; 5. History of severe cardiovascular disease, including New York Heart Association (NYHA) Class III or IV heart failure, coronary artery disease (CAD) with angina or myocardial infarction (MI)/stroke within past 6 months; 6. Subjects who are medically complicated or who are medically unstable (i.e. cancer, dementia, unstable cardiac or respiratory disease, or unstable psychiatric illness); 7. Potential sleep apnea complications that in the opinion of the investigator may affect the health and safety of the participant including: uncontrolled hypertension or hypotension, low blood oxygen (oxygen desaturations nadirs below 75% on their diagnostic PSG), or use of medication or other treatment which may pose additional risk to the subject; 8. Subjects exhibiting any flu-like or any upper airway tract infection symptoms at time of assessment; 9. Subjects with ongoing severe nasal allergies or sinusitis or difficulty breathing through the nose; persistent blockage or one or both nostrils; or any nasal or facial abnormalities that would not allow adequate placement of the device; 10. Subjects with prior surgical intervention for obstructive sleep hypopnea/ apnea syndrome; 11. Currently working nights, rotating night shifts, planned travel across two or more time zones required during study period, or within two weeks prior to study enrollment, or sleep schedule not compatible with sleep lab practices; 12. Unstable use of medications or other agents that may affect sleep or PSG (sedatives or hypnotics); 13. Pregnant (confirmed verbally); 14. Consumption of \> 500mg caffeine per day (e.g. \> 8 cola-type beverages, \> 5 cups of coffee); 15. Currently enrolled in any other research study
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Apnea Hypopnea Index (AHI) | per hour | The Apnea-Hypopnea Index or Apnoea-Hypopnoea Index (AHI) is an index used to indicate the severity of sleep apnea. It is represented by the number of apnea and hypopnea events per hour of sleep. Difference of AHI values between patients who used the FRESCA treatment first versus the CPAP treatment. |
| Oxygen Desaturation Index (ODI) | per hour | The Oxygen Desaturation Index (ODI) is the number of times per hour of sleep that the blood's oxygen level drop by a certain degree from baseline. The ODI is typically measured as part of standard sleep studies, such as a diagnostic polysomnogram, home sleep apnea testing, or with overnight oximetry.Difference of ODI values between patients who used the FRESCA treatment first versus the CPAP treatment. |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Minimum Sleep SpO2 (%) | per night | The minimum O2 level percentage during treatment reported per treatment |
| Mean Sleep SpO2 -(%) | per night | Mean Sleep SpO2 - blood oxygenation level (%) mean value reported per treatment |
| Wakefulness (Min) | per night | Measure of time not sleeping (minutes) |
| Arousal Index (AI) | per hour | The number of arousals per hour; arousals are defined as a change in EEG for at least 3 seconds. |
| Stage N2 (Min) | per night | Stage N2 sleep predominates the sleep stages with 50% of the total sleep time. It follows the Stage N1 sleep and continues to recur throughout the night. |
| Stage N3 (Min) | per night | Stage N3 is considered as 'deep sleep'. It is sometimes referred as slow wave sleep. |
| REM (Min) | per night | The exact function of the REM is uncertain. However, it occupies approximately 25% of the total sleep time. REM sleep cycles occur every 90 to 120 min throughout the night with progressively increasing periods of time. REM sleep is associated with more frequent and longer duration apneas, hypopneas, and severe hypoxemia |
| Stage N1 (Min) | per night | Stage N1 sleep is an estimate of the degree of sleep fragmentation. |
| Sleep Efficiency (SE%) | per night | Sleep Efficiency (%) \[100 x Total sleep time/ total recording time\] reported per treatment |
Countries
United States
Participant flow
Pre-assignment details
Eleven (11) subjects were not included in the primary analysis due to incomplete data on at least one PSG nights. mITT Group (subjects completing 2 nights on study with a Valid PSG result) n=36 See section 8.1 of Clinical Study Report (TR 1000-01) for details.
Participants by arm
| Arm | Count |
|---|---|
| FRESCA Mask First CPAP Mask Second One night using FRESCA nasal mask and the second night using patient provided CPAP | 19 |
| CPAP Mask First and CPAP Mask Second One night using patient providing CPAP nasal mask and second night using FRESCA mask | 17 |
| Total | 36 |
Baseline characteristics
| Characteristic | FRESCA Mask First CPAP Mask Second | CPAP Mask First and CPAP Mask Second | Total |
|---|---|---|---|
| Age, Customized Age age between 18-70 years old | 19 Participants | 17 Participants | 36 Participants |
| Age, Customized Age age less than 18 years old | 0 Participants | 0 Participants | 0 Participants |
| Age, Customized Age age less than 70 years old | 0 Participants | 0 Participants | 0 Participants |
| Apnea-Hypopnea Index >= 5/hr | 23.6 events/hour STANDARD_DEVIATION 15.317 | 28.8 events/hour STANDARD_DEVIATION 19.571 | 26.1 events/hour STANDARD_DEVIATION 17.403 |
| BMI<= 35 kg/m^2 | 30.91 kg/m^2 STANDARD_DEVIATION 2.961 | 29.89 kg/m^2 STANDARD_DEVIATION 3.543 | 30.43 kg/m^2 STANDARD_DEVIATION 3.242 |
| Sex: Female, Male Female | 6 Participants | 4 Participants | 10 Participants |
| Sex: Female, Male Male | 13 Participants | 13 Participants | 26 Participants |
Adverse events
| Event type | EG000 affected / at risk | EG001 affected / at risk |
|---|---|---|
| deaths Total, all-cause mortality | 0 / 47 | 0 / 47 |
| other Total, other adverse events | 4 / 47 | 0 / 47 |
| serious Total, serious adverse events | 0 / 47 | 0 / 47 |
Outcome results
Primary
Apnea Hypopnea Index (AHI)
The Apnea-Hypopnea Index or Apnoea-Hypopnoea Index (AHI) is an index used to indicate the severity of sleep apnea. It is represented by the number of apnea and hypopnea events per hour of sleep. Difference of AHI values between patients who used the FRESCA treatment first versus the CPAP treatment.
Time frame: per hour
Population: The population for analysis for the primary outcomes is the modified Intent-to-Treat (mITT) population. This population consists of the enrolled, intent-to-treat population who has evaluable data for both nights of PSG evaluation.
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| FRESCA Mask First Night | Apnea Hypopnea Index (AHI) | First Night | 1.96 events per hour | Standard Deviation 3.414 |
| FRESCA Mask First Night | Apnea Hypopnea Index (AHI) | Second Night | 1.23 events per hour | Standard Deviation 1.526 |
| FRESCA Mask First Night | Apnea Hypopnea Index (AHI) | Overall | 2.98 events per hour | Standard Deviation 4.783 |
| CPAP Mask First Night | Apnea Hypopnea Index (AHI) | First Night | 3.73 events per hour | Standard Deviation 8.565 |
| CPAP Mask First Night | Apnea Hypopnea Index (AHI) | Second Night | 4.12 events per hour | Standard Deviation 5.857 |
| CPAP Mask First Night | Apnea Hypopnea Index (AHI) | Overall | 2.41 events per hour | Standard Deviation 6.028 |
Comparison: This analysis was planned to assume a non-inferiority (NI) margin of 5 units and a 1-sided alpha level of 2.5%. A 2-sided 95% confidence interval (CI) was also planned to be provided around the difference between treatments, where non-inferiority would also be demonstrated if the upper bound of the 95% CI is less than or equal to the NI margin of 5 units. In this scenario, the 2-sided 95% CI equates to testing the 1-sided non-inferiority hypothesis.p-value: <0.00195% CI: [-1.7, 2.9]t-test, 1 sided
Primary
Oxygen Desaturation Index (ODI)
The Oxygen Desaturation Index (ODI) is the number of times per hour of sleep that the blood's oxygen level drop by a certain degree from baseline. The ODI is typically measured as part of standard sleep studies, such as a diagnostic polysomnogram, home sleep apnea testing, or with overnight oximetry.Difference of ODI values between patients who used the FRESCA treatment first versus the CPAP treatment.
Time frame: per hour
Population: The population for analysis for the primary outcomes is the modified Intent-to-Treat (mITT) population. This population consists of the enrolled, intent-to-treat population who has evaluable data for both nights of PSG evaluation.
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| FRESCA Mask First Night | Oxygen Desaturation Index (ODI) | First Night | 1.11 events per hour | Standard Deviation 1.73 |
| FRESCA Mask First Night | Oxygen Desaturation Index (ODI) | Second Night | 1.05 events per hour | Standard Deviation 1.569 |
| FRESCA Mask First Night | Oxygen Desaturation Index (ODI) | Overall | 1.39 events per hour | Standard Deviation 2.046 |
| CPAP Mask First Night | Oxygen Desaturation Index (ODI) | First Night | 1.2 events per hour | Standard Deviation 2.53 |
| CPAP Mask First Night | Oxygen Desaturation Index (ODI) | Second Night | 1.7 events per hour | Standard Deviation 2.364 |
| CPAP Mask First Night | Oxygen Desaturation Index (ODI) | Overall | 1.12 events per hour | Standard Deviation 2.049 |
Comparison: This analysis was planned to assume a non-inferiority (NI) margin of 5 units and a 1-sided alpha level of 2.5%. A 2-sided 95% confidence interval (CI) was also planned to be provided around the difference between treatments, where non-inferiority would also be demonstrated if the upper bound of the 95% CI is less than or equal to the NI margin of 5 units. In this scenario, the 2-sided 95% CI equates to testing the 1-sided non-inferiority hypothesis.p-value: <0.00195% CI: [-0.4, 1]t-test, 1 sided
Secondary
Arousal Index (AI)
The number of arousals per hour; arousals are defined as a change in EEG for at least 3 seconds.
Time frame: per hour
Population: The population for analysis for the primary outcomes is the modified Intent-to-Treat (mITT) population. This population consists of the enrolled, intent-to-treat population who has evaluable data for both nights of PSG evaluation.
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| FRESCA Mask First Night | Arousal Index (AI) | First Night | 21.95 events per hour | Standard Deviation 15.572 |
| FRESCA Mask First Night | Arousal Index (AI) | Second Night | 17.32 events per hour | Standard Deviation 8.083 |
| FRESCA Mask First Night | Arousal Index (AI) | Overall | 22.92 events per hour | Standard Deviation 12.727 |
| CPAP Mask First Night | Arousal Index (AI) | First Night | 20.94 events per hour | Standard Deviation 8.728 |
| CPAP Mask First Night | Arousal Index (AI) | Second Night | 24.00 events per hour | Standard Deviation 8.895 |
| CPAP Mask First Night | Arousal Index (AI) | Overall | 19.03 events per hour | Standard Deviation 8.473 |
Secondary
Mean Sleep SpO2 -(%)
Mean Sleep SpO2 - blood oxygenation level (%) mean value reported per treatment
Time frame: per night
Population: The population for analysis for the primary outcomes is the modified Intent-to-Treat (mITT) population. This population consists of the enrolled, intent-to-treat population who has evaluable data for both nights of PSG evaluation.
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| FRESCA Mask First Night | Mean Sleep SpO2 -(%) | First Night | 94.89 percentage of O2 Saturation | Standard Deviation 1.41 |
| FRESCA Mask First Night | Mean Sleep SpO2 -(%) | Second Night | 95 percentage of O2 Saturation | Standard Deviation 1.414 |
| FRESCA Mask First Night | Mean Sleep SpO2 -(%) | Overall | 95.14 percentage of O2 Saturation | Standard Deviation 1.376 |
| CPAP Mask First Night | Mean Sleep SpO2 -(%) | First Night | 95.35 percentage of O2 Saturation | Standard Deviation 1.498 |
| CPAP Mask First Night | Mean Sleep SpO2 -(%) | Second Night | 95.41 percentage of O2 Saturation | Standard Deviation 1.326 |
| CPAP Mask First Night | Mean Sleep SpO2 -(%) | Overall | 95.17 percentage of O2 Saturation | Standard Deviation 1.444 |
Secondary
Minimum Sleep SpO2 (%)
The minimum O2 level percentage during treatment reported per treatment
Time frame: per night
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| FRESCA Mask First Night | Minimum Sleep SpO2 (%) | First Night | 89.16 percentage of O2 Saturation | Standard Deviation 3.775 |
| FRESCA Mask First Night | Minimum Sleep SpO2 (%) | Second Night | 91.95 percentage of O2 Saturation | Standard Deviation 2.321 |
| FRESCA Mask First Night | Minimum Sleep SpO2 (%) | Overall | 89.11 percentage of O2 Saturation | Standard Deviation 4.609 |
| CPAP Mask First Night | Minimum Sleep SpO2 (%) | First Night | 91.41 percentage of O2 Saturation | Standard Deviation 3.858 |
| CPAP Mask First Night | Minimum Sleep SpO2 (%) | Second Night | 89.06 percentage of O2 Saturation | Standard Deviation 5.517 |
| CPAP Mask First Night | Minimum Sleep SpO2 (%) | Overall | 91.69 percentage of O2 Saturation | Standard Deviation 3.106 |
Secondary
REM (Min)
The exact function of the REM is uncertain. However, it occupies approximately 25% of the total sleep time. REM sleep cycles occur every 90 to 120 min throughout the night with progressively increasing periods of time. REM sleep is associated with more frequent and longer duration apneas, hypopneas, and severe hypoxemia
Time frame: per night
Population: The population for analysis for the primary outcomes is the modified Intent-to-Treat (mITT) population. This population consists of the enrolled, intent-to-treat population who has evaluable data for both nights of PSG evaluation.
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| FRESCA Mask First Night | REM (Min) | First Night | 60.63 minutes | Standard Deviation 23.15 |
| FRESCA Mask First Night | REM (Min) | Second Night | 93.79 minutes | Standard Deviation 31.101 |
| CPAP Mask First Night | REM (Min) | First Night | 72.29 minutes | Standard Deviation 26.343 |
| CPAP Mask First Night | REM (Min) | Second Night | 58.82 minutes | Standard Deviation 25.914 |
Secondary
Sleep Efficiency (SE%)
Sleep Efficiency (%) \[100 x Total sleep time/ total recording time\] reported per treatment
Time frame: per night
Population: The population for analysis for the primary outcomes is the modified Intent-to-Treat (mITT) population. This population consists of the enrolled, intent-to-treat population who has evaluable data for both nights of PSG evaluation.
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| FRESCA Mask First Night | Sleep Efficiency (SE%) | First Night | 80.63 percentage of sleep efficiency | Standard Deviation 7.697 |
| FRESCA Mask First Night | Sleep Efficiency (SE%) | Second Night | 86.68 percentage of sleep efficiency | Standard Deviation 7.212 |
| FRESCA Mask First Night | Sleep Efficiency (SE%) | Overall | 79.39 percentage of sleep efficiency | Standard Deviation 8.419 |
| CPAP Mask First Night | Sleep Efficiency (SE%) | First Night | 84.47 percentage of sleep efficiency | Standard Deviation 11.549 |
| CPAP Mask First Night | Sleep Efficiency (SE%) | Second Night | 78 percentage of sleep efficiency | Standard Deviation 9.192 |
| CPAP Mask First Night | Sleep Efficiency (SE%) | Overall | 85.64 percentage of sleep efficiency | Standard Deviation 9.433 |
Secondary
Stage N1 (Min)
Stage N1 sleep is an estimate of the degree of sleep fragmentation.
Time frame: per night
Population: The population for analysis for the primary outcomes is the modified Intent-to-Treat (mITT) population. This population consists of the enrolled, intent-to-treat population who has evaluable data for both nights of PSG evaluation.
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| FRESCA Mask First Night | Stage N1 (Min) | First Night | 43.53 minutes | Standard Deviation 20.614 |
| FRESCA Mask First Night | Stage N1 (Min) | Second Night | 40.26 minutes | Standard Deviation 18.363 |
| CPAP Mask First Night | Stage N1 (Min) | First Night | 49.88 minutes | Standard Deviation 19.906 |
| CPAP Mask First Night | Stage N1 (Min) | Second Night | 53.47 minutes | Standard Deviation 25.873 |
Secondary
Stage N2 (Min)
Stage N2 sleep predominates the sleep stages with 50% of the total sleep time. It follows the Stage N1 sleep and continues to recur throughout the night.
Time frame: per night
Population: The population for analysis for the primary outcomes is the modified Intent-to-Treat (mITT) population. This population consists of the enrolled, intent-to-treat population who has evaluable data for both nights of PSG evaluation.
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| FRESCA Mask First Night | Stage N2 (Min) | First Night | 193.42 minutes | Standard Deviation 55.529 |
| FRESCA Mask First Night | Stage N2 (Min) | Second Night | 214.89 minutes | Standard Deviation 56.916 |
| CPAP Mask First Night | Stage N2 (Min) | First Night | 198.41 minutes | Standard Deviation 43.364 |
| CPAP Mask First Night | Stage N2 (Min) | Second Night | 188.88 minutes | Standard Deviation 45.862 |
Secondary
Stage N3 (Min)
Stage N3 is considered as 'deep sleep'. It is sometimes referred as slow wave sleep.
Time frame: per night
Population: The population for analysis for the primary outcomes is the modified Intent-to-Treat (mITT) population. This population consists of the enrolled, intent-to-treat population who has evaluable data for both nights of PSG evaluation.
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| FRESCA Mask First Night | Stage N3 (Min) | First Night | 59.21 minutes | Standard Deviation 44.065 |
| FRESCA Mask First Night | Stage N3 (Min) | Second Night | 56.21 minutes | Standard Deviation 48.433 |
| CPAP Mask First Night | Stage N3 (Min) | First Night | 60.35 minutes | Standard Deviation 50.447 |
| CPAP Mask First Night | Stage N3 (Min) | Second Night | 42.94 minutes | Standard Deviation 39.366 |
Secondary
Wakefulness (Min)
Measure of time not sleeping (minutes)
Time frame: per night
Population: The population for analysis for the primary outcomes is the modified Intent-to-Treat (mITT) population. This population consists of the enrolled, intent-to-treat population who has evaluable data for both nights of PSG evaluation.
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| FRESCA Mask First Night | Wakefulness (Min) | First Night | 78.95 minutes | Standard Deviation 35.68 |
| FRESCA Mask First Night | Wakefulness (Min) | Second Night | 51.79 minutes | Standard Deviation 32.898 |
| FRESCA Mask First Night | Wakefulness (Min) | Overall | 84.58 minutes | Standard Deviation 40.177 |
| CPAP Mask First Night | Wakefulness (Min) | First Night | 61.06 minutes | Standard Deviation 58.463 |
| CPAP Mask First Night | Wakefulness (Min) | Second Night | 90.88 minutes | Standard Deviation 44.933 |
| CPAP Mask First Night | Wakefulness (Min) | Overall | 56.17 minutes | Standard Deviation 45.272 |