Table 1: Selection criteria for study participation.
Inclusion Criteria |
1. ≥ 21 and ≤ 70 years of age |
2. Moderate-to-severe obstructive sleep apnea (defined as apnea-hypopnea index of 15-50 events/hour on baseline screening polysomnogram) |
3. Participant intolerant of positive airway pressure therapy (defined as < 2 hours of use per night for ≥ 5 nights per week)* |
4. Participant signs and dates a written informed consent form and indicates thorough understanding of the study protocol, procedures, and risks |
*Mask leaks, claustrophobia, discomfort, latex allergies, recurrent upper respiratory infection, noise disturbance, restricted movement limiting sleep |
Exclusion Criteria |
1. Any evidence that apnea is not caused by the base of the tongue (i.e. central apnea, neurologic disorder, retropalatal collapse, nasal obstruction) |
2. Any condition likely requiring magnetic resonance imaging |
3. Any factor that, in the surgeon’s judgment, would pose a risk to surgery or placement of a long-term implanted device |
4. Any factor that, in the surgeon’s judgment, would make the participant unlikely to respond to Magnap treatment |
5. Congenital anomalies of the larynx, pharynx, or trachea, or any other anatomical abnormality of the head, neck, or chest that would be a contraindication to placement of the Magnap device or external brace usage |
6. No exclusion criteria based on gender, race, or ethnicity |