Table S1.

Inclusion and exclusion criteria

Inclusion Criteria

1. Age ≥ 18 years

2. Diagnosis of OSA

3. AHI ≥ 10 on diagnostic PSG performed within last 3 months

4. Investigator believes that patient can benefit from OSA treatment

5. Patient understands and is willing and able to comply with study requirements

Exclusion Criteria

1. Use of any device that interferes with nasal or oral breathing

2. Persistent blockage of one or both nostrils which prevents airflow in one or both nostrils

3. Any chronic sores or lesions on the inside or outside of the nose

4. Chronic use of nasal decongestants other than nasal steroids

5. Oxygen saturation < 75% for > 10% of the diagnostic PSG

6. Oxygen saturation < 75% for > 25% of the first 4 hours of the diagnostic PSG

7. Prior or near-miss motor vehicle accident due to sleepiness in the past 12 months

8. Current use of hypnotics, anxiolytics, sedating antidepressants, anticonvulsants, sedating antihistamines, stimulants, or other medications likely to affect neurocognitive function and/or alertness

9. History of allergic reaction to acrylic-based adhesives (such as those found in BAND-AIDS)

10. Current acute upper respiratory (including nasal, sinus, or middle ear) inflammation or infection or perforation of the tympanic membrane*

11. History of frequent and/or poorly treated severe nasal allergies or sinusitis which may interfere with the ability to use Provent

12. Narcolepsy, idiopathic hypersomnolence, chronic insomnia, restless legs syndrome, REM sleep behavior disorder, or any other diagnosed or suspected sleep disorder other than OSA that could affect sleepiness scales or the likelihood of apneas/hypopneas during a PSG

13. Current use of diurnal or nocturnal supplemental oxygen

14. History of CPAP use in the home for the treatment of OSA. Temporary use of CPAP in a laboratory setting does not exclude the patient from participating.

15. History of use of oral appliances in the home for the treatment of OSA

16. History of prior surgery for OSA (e.g., somnoplasty, uvulopalatopharyngoplasty, laser-assisted uvulopalatoplasty, mandibular advancement, Pillar procedure). Patients may participate if prior surgery was limited to the nose, sinuses, and/or turbinates, etc.

17. Currently working night or rotating shifts

18. Consumption of > 10 caffeinated beverages per day (approximately 1000 mg per day)

19. History of severe cardiovascular disease, including New York Heart Association Class III or IV heart failure, coronary artery disease with angina, or myocardial infarction in the past 6 months; stroke in the past 6 months

20. History of cardiac rhythm disturbance (defined as a 5-beat run of sustained ventricular tachycardia or bradycardia if < 30 beats per min for a 10-second run or previously undiagnosed and untreated atrial fibrillation or Mobitz II or third-degree heart block)

21. Uncontrolled hypertension, defined as SBP > 180 or DBP > 105 mm Hg

22. Uncontrolled hypotension, defined as SBP < 80 or DBP < 55 mm Hg

23. History of severe respiratory disorders (including respiratory muscle weakness, bullous lung disease, bypassed upper airway, pneumothorax, pneumomediastinum, etc.) or unstable respiratory disease (e.g., asthma or chronic obstructive pulmonary disease with exacerbation in the last 3 months)

24. Any other serious, uncontrolled medical condition that may impair follow-up or put the patient at undue risk

25. Females of child bearing age who are pregnant or intending to become pregnant. Proof of non-pregnancy with a urine or blood test is not required.

26. Consumes on average more than 3 drinks of alcohol per day

27. Chronic neurologic disorders affecting neurocognitive abilities or daily function

28. Cancer, unless in remission for more than 1 year. A patient with a history of a small basal cell carcinoma (without metastasis) that was excised with wide margins may be included at the discretion of the Investigator.

29. Current psychiatric illness likely to impair ability to participate in study without undue risk

30. Smokers whose habit interferes with the overnight PSG

31. Any known illicit drug usage

^*Subject may be reconsidered for participation after the acute episode resolves.