Automatic activation of neurostimulation for central sleep apnea results in high nightly usage

Purpose: Adherence with mask-based therapies remains a significant challenge for patients with sleep-disordered breathing. Transvenous phrenic nerve stimulation (TPNS) to treat central sleep apnea (CSA) in adults offers a novel, automated approach to enhance nightly adherence by initiating therapy automatically based on patient-specific programmed conditions such as sleep schedule, activity, and body position. This retrospective analysis aims to determine the adherence achieved with TPNS’s automated activation approach. Methods: Device data from 131 remedē^®System Pivotal Trial participants were analyzed to calculate median daily hours of therapy within 14 days prior to visits. Therapy duration was defined as time when all conditions to activate therapy were met between the first-time therapy on to last time off during the night. Results: Median [Q1-Q3] nightly therapy duration at 6, 12, 18, and 24 months was 5.9 [4.9–6.6], 5.7 [5.0-6.8], 6.0 [5.3–6.8], and 5.9 [4.9–6.5] hours, respectively. Using a definition for adequate therapy as the percentage of patients with usage ≥ 4 h/night for 70% of nights, 86%, 82%, 83%, and 90% of patients met the criteria at these visits. Two patients (< 2%) discontinued treatment before 6 months for stimulation intolerance. Patients with adequate therapy reported more quality of life improvement. Conclusion: Automatic activation of TPNS therapy was associated with consistent use in over 80% of patients through 18 months. Higher usage may yield a greater overall reduction in CSA burden over the whole night compared to therapies requiring the patient to initiate the therapy. ClinicalTrials.gov identifier: NCT01816776 (21MAR2013) Brief summary: Current Knowledge/Study Rationale: Adherence to mask-based therapies has been a challenge. Usage and adherence of transvenous phrenic nerve stimulation therapy has a potential to be higher with automatic therapy activation when programmed conditions are met. Study Impact: The automatic activation of transvenous phrenic nerve stimulation therapy resulted in a higher duration of nightly usage and higher rate of adequate delivered therapy than generally are reported for mask-based therapies. High usage may yield a greater overall reduction in central sleep apnea burden over the whole night compared to therapies that require the patient to initiate the therapy, especially later in the night when CSA is more likely to occur.