Trial Search Results

Randomized Study of Provent Versus Sham Device to Treat Obstructive Sleep Apnea

Primary Endpoints:

•Comparison of difference in AHI at one-week in-lab polysomnography between "device on" and "device off" nights, controlling for sleep position (supine vs. non-supine)

Secondary Endpoints: By polysomnography, reduction in:

- AHI with device on vs. off at 3 months, controlling for sleep position

- Oxygen desaturation index with device on vs. off

- Arousal index with device on vs. off

- Duration of snoring with device on vs. off

- Epworth Sleepiness Scale

Patient acceptance, in terms of:

- Refusal rate at screening

- Discontinuation rate during follow-up

- Daily compliance rate

- Device-related adverse events

- Serious adverse events

Stanford is currently not accepting patients for this trial.

Lead Sponsor:

Ventus Medical, Inc.

Stanford Investigator(s):

Intervention(s):

  • Device: Provent Professional Sleep Apnea Therapy Device
  • Device: Sham Device

Phase:

Phase 4

Eligibility


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 subject can benefit from OSA tx

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

Exclusion Criteria:

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

   2. Persistent blockage of one or both nostrils

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

   4. Chronic use of nasal decongestants other than nasal steroids

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

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

   7. Prior or near-miss motor vehicle accident due to sleepiness (last 12 mo.)

   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

10. Current acute upper respiratory inflammation/infection or perforation of the tympanic
   membrane

11. History of frequent and/or poorly treated severe nasal allergies or sinusitis

12. Narcolepsy, idiopathic hypersomnolence, chronic insomnia, RLS, REM sleep behavior
   disorder or any other diagnosed or suspected sleep disorder

13. Current use of diurnal or nocturnal supplemental oxygen

14. History of CPAP use in the home for OSA tx

15. History of use of oral appliances for OSA tx

16. History of prior surgery for OSA

17. Currently working night or rotating shifts

18. Consumption of > 10 caffeinated beverages per day

19. History of severe cardiovasc. disease, including NYHA Class III or IV heart failure,
   CAD with angina or MI/stroke in past 6 months

20. History of cardiac rhythm disturbance

21. Uncontrolled hypertension (SBP > 180 or DBP > 105 mm Hg)

22. Uncontrolled hypotension(SBP < 80 or DBP < 55 mm Hg

23. History of severe respiratory disorders or unstable respiratory disease

24. Any other serious, uncontrolled medical condition

25. Females of child bearing age who are pregnant or intending to become pregnant

26. Consumes more than 3 drinks of alcohol/day

27. Chronic neurologic disorders

28. Cancer, unless in remission for more than 1 year

29. Current psychiatric illness

30. Smokers whose habit interferes with the overnight PSG

31. Any known illicit drug usage

Ages Eligible for Study

18 Years - N/A

Genders Eligible for Study

All

Not currently accepting new patients for this trial

Contact Information

Stanford University
School of Medicine
300 Pasteur Drive
Stanford, CA 94305
Chia-Yu Cardell
6507217576
Not Recruiting