| Design | Uncontrolled prospective cohort study with a randomised withdrawal sub-study |
|---|---|
| Treatment | Implanted hypoglossal nerve stimulation |
| Control | None — single-group cohort |
| Population | 126 participants, 83% men, mean age 54.5 years, mean BMI 28.4 |
| Follow-up | 12 months |
| Primary endpoint | Change in apnoea-hypopnoea index and oxygen desaturation index at 12 months |
| Result | Median AHI fell 68%, from 29.3 to 9.0 events per hour (p<0.001). Oxygen desaturation index fell 70%, from 25.4 to 7.4 events per hour (p<0.001). Secondary measures of sleep apnoea burden also improved. |
| Secondary endpoints | Sleepiness, functional outcomes, quality of life |
In this uncontrolled cohort study, upper-airway stimulation led to significant improvements in objective and subjective measurements of the severity of obstructive sleep apnea.
The trial authors, in the published abstract
The authors label it uncontrolled in their own conclusion, and that matters: the headline figures come from a single-arm cohort in selected, relatively slim patients with specific airway collapse patterns. It established the therapy as viable for CPAP-intolerant patients, not as equivalent to CPAP.
Strollo PJ Jr, Soose RJ, Maurer JT, et al. Upper-airway stimulation for obstructive sleep apnea. N Engl J Med 2014 Jan 9;370(2):139-49.