Apnicure Winx, User Manual, Page: 48 / 60

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Exclusion Criteria
• OSA treatment within two weeks prior to first PSG night.
• Poor nasal patency as evidenced by Peak Nasal Inspiratory Flow (PNIF) less than 75 L/min (assessed at baseline medical visit). In addition,
any ongoing process or condition that limits nasal breathing or indications thereof, including: obligate mouth-breathing, persistent blockage
of one or both nostrils resulting in the inability to sleep with the mouth closed, chronic nasal congestion, chronic allergic rhinitis, and
intermittent allergic rhinitis that does not respond to non-sedating/non-stimulating medical therapy.
• Oral cavity infection or any other oral or dental condition or problem that would limit subject use of the Winx Sleep Therapy System (e.g.
dentures, loose tooth/teeth, temporomandibular joint (TMJ) conditions, or any oral or dental condition that the Investigator believes could
be exacerbated by the Winx Sleep Therapy System.
• Prior use of the Winx Sleep Therapy System.
• History of any OSA surgical treatment including uvulopalatopharyngoplasty surgery (UPPP), maxillomandibular advancement surgery
(MMA), radio frequency (RF) ablation treatment, palatal stent devices, etc.
• Current use or use within the previous 2 weeks of medications or other agents that may affect sleep or PSG, including:
° Hypnotics, anxiolytics, anticonvulsants, sedating antihistamines, stimulants, sedating antidepressants or other medications likely to affect
neurocognitive function and/or alertness. Patients on stable selective serotonin reuptake inhibitor (SSRI) therapy for > 3 months, and who
are expected to remain on therapy for the Study duration, may continue SSRI treatment.
° Consumption of > 500mg caffeine per day (e.g. > 8 cola-type beverages, > 5 cups of coffee).
° Any known illicit drug use or abuse within the past year, or failure to pass drug urine screen test, or alcohol breathalyzer test with result
over 0.05% BAL.
° Smokers who smoke during the night.
• Any concomitant diagnosed or suspected sleep or chronic neurological disorders, other than OSA, including insomnia, and central sleep
apnea.
• Currently working nights, rotating night shifts, planned travel across four 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.
• Potential sleep apnea complications that, in the opinion of the investigator, may affect the health or safety of the participant, including:
low blood oxygen, recent near-miss or prior automobile accident due to sleepiness, reported history of severe cardiovascular disease
(including NYHA class III or IV heart failure, CAD with angina or MI/stroke in past 6 months, uncontrolled hypertension or hypotension,
cardiac arrhythmias), reported respiratory disorders, or use of medication or other treatment which may pose additional risk to the subject or
confound the results of the Study.
• Female subjects who are pregnant or intend to become pregnant during the study period.
PN 12149-B.indd 42 4/23/13 11:53 AM