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.
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.
Study Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
NONE
Enrollment
47
FRESCA nasal mask first night
CPAP Nasal Mask first night
Sequoia Sleep Diagnostics
Fresno, California, United States
Complete Sleep Solutions
Murrieta, California, United States
Broward Research Group
Hollywood, Florida, United States
CliniLabs, Inc
New York, New York, United States
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
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
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
Sleep Efficiency (SE%)
Sleep Efficiency (%) \[100 x Total sleep time/ total recording time\] reported per treatment
Time frame: per night
Minimum Sleep SpO2 (%)
The minimum O2 level percentage during treatment reported per treatment
Time frame: per night
Mean Sleep SpO2 -(%)
Mean Sleep SpO2 - blood oxygenation level (%) mean value reported per treatment
Time frame: per night
Wakefulness (Min)
Measure of time not sleeping (minutes)
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SleepMed of South Carolina
Columbia, South Carolina, United States
Time frame: per night
Stage N1 (Min)
Stage N1 sleep is an estimate of the degree of sleep fragmentation.
Time frame: per night
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
Stage N3 (Min)
Stage N3 is considered as 'deep sleep'. It is sometimes referred as slow wave sleep.
Time frame: per night
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