1. Initiation of therapy for obstructive sleep apnea syndrome: a randomized comparison of outcomes of telemetry-supported home-based vs. sleep lab-based therapy initiation
- Author
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Aline Lips, Thomas Penzel, Katharina Lederer, Holger Woehrle, Leslee Willes, Ingo Fietze, Gina Wewer, and Sebastian Herberger
- Subjects
Automatic positive airway pressure ,Adult ,Male ,medicine.medical_specialty ,medicine.medical_treatment ,Population ,Continuous positive airway pressure ,Polysomnography ,03 medical and health sciences ,Therapy compliance ,Young Adult ,0302 clinical medicine ,Quality of life ,Internal medicine ,Post-hoc analysis ,Clinical endpoint ,medicine ,Humans ,Telemetry ,education ,Aged ,Aged, 80 and over ,education.field_of_study ,Sleep Apnea, Obstructive ,medicine.diagnostic_test ,business.industry ,Middle Aged ,medicine.disease ,Obstructive sleep apnea ,Home Care Services ,Treatment Outcome ,030228 respiratory system ,Otorhinolaryngology ,Adherence ,Female ,Neurology (clinical) ,business ,Laboratories ,Sleep ,030217 neurology & neurosurgery ,600 Technik, Medizin, angewandte Wissenschaften::610 Medizin und Gesundheit::610 Medizin und Gesundheit ,Compliance - Abstract
Purpose Diagnosis and treatment of obstructive sleep apnea are traditionally performed in sleep laboratories with polysomnography (PSG) and are associated with significant waiting times for patients and high cost. We investigated if initiation of auto-titrating CPAP (APAP) treatment at home in patients with obstructive sleep apnea (OSA) and subsequent telemonitoring by a homecare provider would be non-inferior to in-lab management with diagnostic PSG, subsequent in-lab APAP initiation, and standard follow-up regarding compliance and disease-specific quality of life. Methods This randomized, open-label, single-center study was conducted in Germany. Screening occurred between December 2013 and November 2015. Eligible patients with moderate-to-severe OSA documented by polygraphy (PG) were randomized to home management or standard care. All patients were managed by certified sleep physicians. The home management group received APAP therapy at home, followed by telemonitoring. The control group received a diagnostic PSG, followed by therapy initiation in the sleep laboratory. The primary endpoint was therapy compliance, measured as average APAP usage after 6 months. Results The intention-to-treat population (ITT) included 224 patients (110 home therapy, 114 controls); the per-protocol population (PP) included 182 patients with 6-month device usage data (89 home therapy, 93 controls). In the PP analysis, mean APAP usage at 6 months was not different in the home therapy and control groups (4.38 ± 2.04 vs. 4.32 ± 2.28, p = 0.845). The pre-specified non-inferiority margin (NIM) of 0.3 h/day was not achieved (p = 0.130); statistical significance was achieved in a post hoc analysis when NIM was set at 0.5 h/day (p < 0.05). Time to APAP initiation was significantly shorter in the home therapy group (7.6 ± 7.2 vs. 46.1 ± 23.8 days; p < 0.0001). Conclusion Use of a home-based telemonitoring strategy for initiation of APAP in selected patients with OSA managed by sleep physicians is feasible, appears to be non-inferior to standard sleep laboratory procedures, and facilitates faster access to therapy.
- Published
- 2020