Provent® Sleep Apnea Therapy is a disposable nightly-use nasal device. The Provent Nasal Device is placed just inside the nostrils and is held in place by adhesive. The device directs expiratory flow through small holes, which increases airway pressure during the expiratory phase of the respiratory cycle in similar fashion to the expiratory phase of CPAP therapy. This airway pressure is maintained until the start of the next inspiration. The expiratory resistance created by the Provent Nasal Device helps maintain an open airway during sleep. Provent Therapy is offered in two expiratory resistances in some markets (HR = High Resistance, SR = Standard Resistance) to accommodate varying patient preferences. The Provent Nasal Device should be used only after consultation with a licensed healthcare professional.
IndicationsProvent Sleep Apnea Therapy is indicated for the treatment of obstructive sleep apnea (OSA).
ContraindicationsBased on clinical studies involving similar therapies, Provent Sleep Apnea Therapy is contraindicated for use in patients with the following conditions:
- Severe respiratory disorders including respiratory muscle weakness, bullous lung disease (as seen in some types of emphysema), bypassed upper airway, pneumothorax, pneumomediastinum, 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 ear drum.
- 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 the Provent Nasal Device and consult a physician.
- Patients who are unable to breathe through their mouth or experience excessive discomfort when breathing through the device should discontinue use of the Provent Nasal Device and consult a physician.
- Patients who develop nasal, sinus or ear infection or inflammation should discontinue use of the Provent Nasal Device and consult a physician.
- Patients who experience severe nose bleed should discontinue use of the Provent Nasal Device 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 the Provent Nasal Device and consult a physician.
- Keep out of reach of children.
- Patients should be instructed to breathe through their mouth while falling asleep.
- The safety and effectiveness of Provent Therapy in pregnant women, children under the age of 18, and patients with central sleep apnea have not been established.
- Patients should not use any single Provent Nasal Device for longer than one sleep cycle (e.g., overnight). The Provent Nasal Device is intended for single use only and should be disposed of after use.
- Reuse of the Provent Nasal Device will weaken the adhesive, resulting in an inadequate seal and reduced effectiveness of the device.
- Patients should not use the Provent Nasal Device if they have any sores, abrasions, or skin or mucosal irritation on or around the nose.