Is Inspire therapy (Upper Airway Stimulation) only for Obstructive Sleep Apnea (OSA) patients with poor compliance to Continuous Positive Airway Pressure (CPAP) therapy or can discomfort with masks be an indication?

Inspire Therapy for OSA: Indications Beyond CPAP Non-Compliance

Inspire therapy (hypoglossal nerve stimulation) is indicated for patients with moderate to severe OSA who cannot use CPAP due to either poor compliance OR mask discomfort, with both being valid indications according to current guidelines.

Patient Selection Criteria for Inspire Therapy

Hypoglossal nerve stimulation (HNS) with Inspire is recommended for patients who:

• Have moderate to severe OSA (AHI 15-65 events/hour)
• Have failed CPAP therapy due to:
  • Poor compliance/adherence
  • Mask discomfort or intolerance
  • Other CPAP-related side effects (claustrophobia, skin irritation, etc.)
• Have BMI ≤35 kg/m²
• Do not have complete concentric collapse at the soft palate during drug-induced sleep endoscopy 1

Evidence Supporting Mask Discomfort as a Valid Indication

The European Respiratory Society (ERS) guidelines recognize that many patients suffer from local side effects at the nose or face, or discomfort due to the mask, which leads them to seek alternative treatment options 2. This recognition supports mask discomfort as a legitimate reason to consider alternative therapies like Inspire.

The 2021 ERS guideline on non-CPAP therapies acknowledges that patient preference and comfort significantly impact adherence to therapy, noting that "the importance of patient-related outcomes becomes increasingly important in the indication and selection of OSA therapies" 2. This patient-centered approach recognizes that mask discomfort is a valid consideration in treatment selection.

Efficacy of Inspire Therapy

Research demonstrates that Inspire therapy is highly effective for appropriate candidates:

• Significant reduction in AHI from baseline (mean 38.9 to 4.5) 3
• 65% of patients achieve an AHI ≤5 (considered "curative") 3
• Superior to traditional surgical options like UPPP 3
• Substantial improvement in quality of life measures 4
• High adherence rates (39.1 ± 14.9 hours per week) 5

Treatment Algorithm for OSA Patients with CPAP Issues

1. First step: Optimize CPAP therapy

   • Try different mask interfaces (nasal masks show better adherence than oronasal masks) 2
   • Consider humidification to reduce side effects 2
   • Adjust pressure settings or try modified pressure profiles if needed

2. If CPAP optimization fails due to compliance issues OR mask discomfort:

   • For mild to moderate OSA: Consider mandibular advancement devices (MADs) 1
   • For moderate to severe OSA: Evaluate for Inspire therapy candidacy 1

3. Inspire therapy evaluation:

   • Confirm BMI ≤35 kg/m²
   • Perform drug-induced sleep endoscopy to rule out complete concentric collapse
   • Assess overall health status and surgical risk

Cost-Effectiveness Considerations

Inspire therapy has been shown to be cost-effective compared to no treatment, with an incremental cost-effectiveness ratio (ICER) of £17,989 per QALY gained 6. This makes it a reasonable option from both clinical and economic perspectives for appropriate candidates.

Important Caveats and Considerations

• Not all patients with mask discomfort will qualify for Inspire therapy; they must meet all other selection criteria
• Before proceeding to Inspire, ensure CPAP failure is not due to correctable issues like inadequate mask fit or inappropriate pressure settings 1
• Regular follow-up and monitoring of device efficacy is essential
• Surgical risks, though minimal, should be discussed with patients

By following this algorithm and considering both poor compliance AND mask discomfort as valid indications for Inspire therapy in appropriate candidates, clinicians can optimize outcomes for patients with OSA who cannot tolerate CPAP therapy.