If a patient complains of excessive daytime sleepiness, there can be a number of reasons why he may not be getting enough sleep at night. Perhaps the patient simply needs to get to bed earlier or avoid caffeine close to bedtime. But if the patient or the patient's sleep partner complains of snoring or gasping as well, it's possible that the patient suffers from obstructive sleep apnea (OSA).

Although you may need to refer the patient to a sleep center to diagnose OSA, there is a new treatment option for patients who suffer from OSA: PROVENT® Sleep Apnea Therapy.

What Is PROVENT Therapy?

PROVENT Therapy is a simple and easy-to-use treatment for OSA that eliminates the need for the cumbersome tubing, mask, and machine of continuous positive airway pressure (CPAP) therapy.

The PROVENT Nasal Device is placed just over the nostrils and is held in place by a discreet hypoallergenic adhesive. Patients discard the single use device after waking up.

For additional information on PROVENT Therapy, please contact your local Ventus Medical representative or send an e-mail.

Clinically Proven Efficacy

PROVENT Therapy has been proven effective in three clinical studies, the results of which are summarized below.

• In three clinical studies, there were a total of 69 subjects (59 with OSA) who participated and over 1,200 nights of study^3-5
• Significant improvements in apnea-hypopnea index (AHI), apnea index (AI), and oxygen desaturation index (ODI) achieved^3-5
• 72.4% of subjects had greater than 50% AHI reduction or treatment AHI of less than 10^3,4

Clinical Study

• In a clinical study of 34 subjects using PROVENT Therapy at home for 30 days, PROVENT Therapy was used all night on 94% of nights⁴
• Significant improvement in Epworth Sleepiness Scale demonstrated⁴
• Works across OSA severity, body mass index (BMI), age, gender, race^3-5
• Device effect persisted at 1 month⁴
• Expiratory positive airway pressure (EPAP) was shown to be part of the mechanism of action⁵
• OSA subjects experienced 65% reduction in snoring³
• No device-related serious adverse events were reported^3-5

There are four additional clinical trials of the PROVENT device that are listed below. Three of the four were recently completed but results have not yet been released.

• A prospective, multicenter, parallel group, sham-controlled, randomized, double-blinded clinical trial to compare the safety and effectiveness of the PROVENT Sleep Apnea Therapy device to sham for the non-invasive treatment of obstructive sleep apnea
  This multi-center clinical trial enrolled 250 subjects and followed subjects for three months. Results of this trial are pending.
  http://clinicaltrials.gov/ct2/show/NCT00772044
• A prospective, multicenter, single arm, open label clinical trial to evaluate the long-term durability of treatment response and safety of the PROVENT Sleep Apnea Therapy Device for the non-invasive treatment of obstructive sleep apnea
  This multi-center clinical trial is a single arm extension of the randomized trial and has enrolled 42 subjects. 12 month follow-up is ongoing.
  http://clinicaltrials.gov/ct2/show/NCT00849043
• A Non-Randomized, Case Series Study of the Effectiveness of Treatment of Obstructive Sleep Apnea Patients Who Are Non-Compliant or Minimally Adherent with Positive Airway Pressure (PAP) Therapy
  This clinical trial enrolled 59 subjects at St. Luke's Hospital Sleep Medicine and Research Center in St. Louis, Missouri. The results of this trial are pending.
  http://clinicaltrials.gov/ct2/show/NCT00901771
• Nasal ePAP Therapy for Obstructive Sleep Apnea: Evaluating Physiologic and Clinical parameters
  This clinical trial enrolled 29 subjects at the Division of Pulmonary & Critical Care Medicine at New York University School of Medicine. The objective of the study was to evaluate the efficacy and physiologic mechanism by which improves sleep disordered breathing. The results of this trial are pending.

Contraindications

Based on clinical studies involving other positive airway therapies, the PROVENT Nasal Device is contraindicated for use in patients with the following conditions:

• Severe respiratory disorders (including respiratory muscle weakness, bullous lung disease, bypassed upper airway, pneumothorax, pneumomediastium, etc.)
• Severe heart disease (including heart failure)
• Pathologically low blood pressure
• An acute upper respiratory (including nasal, sinus, or middle ear) inflammation or infection, or perforation of the tympanic membrane

Warnings

• Assessment of effectiveness and follow-up testing and evaluation should be conducted to ensure adequate treatment effect
• Patients who experience an allergic reaction to any part of the device should discontinue use of PROVENT Therapy and consult a physician
• Patients who are unable to breathe through their mouth, experience excessive discomfort when breathing through the device, or experience any abnormal breathing patterns should discontinue use of PROVENT Therapy and consult a physician
• Patients who develop nasal, sinus, or middle ear infection or inflammation should discontinue use of PROVENT Therapy and consult a physician
• Patients who experience severe epistaxis (nose bleed) should discontinue use of PROVENT Therapy and consult a physician
• Patients who develop skin or mucosal irritation, rash, sores, or other discomfort in or around the nose should discontinue use of PROVENT Therapy and consult a physician
• Keep out of reach of children

Precautions

• Patients should be instructed to breathe through their mouth while falling asleep if mouth breathing is more comfortable than nasal breathing through the device
• The safety and effectiveness of PROVENT Professional Sleep Apnea Therapy in pregnant women, children under the age of 18, and patients with central sleep apnea has not been established
• Patients should not use any single PROVENT Nasal Device for longer than one sleep cycle (e.g., overnight). PROVENT Therapy is intended for single use only and should be disposed of after use
• Patients should not use PROVENT Therapy if they have any sores, abrasions, or skin or mucosal irritation on or around the entrance to the nose

Adverse Reactions

Potential adverse reactions include: increased mouth breathing while asleep, which may worsen snoring or OSA; nasal, sinus, or middle ear discomfort; nose bleed; dry mouth; nostril pain or dilation; and headache.