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Area of Science:

  • Sleep Medicine
  • Respiratory Medicine
  • Clinical Trials

Background:

  • Obstructive sleep apnoea syndrome (OSAS) is commonly treated with fixed-level continuous positive airway pressure (fCPAP).
  • Automatic continuous positive airway pressure (autoCPAP) devices are increasingly utilized for home therapy.
  • This study compares the long-term efficacy of autoCPAP versus fCPAP in managing OSAS symptoms.

Purpose of the Study:

  • To determine if autoCPAP is equivalent to fCPAP in improving long-term sleepiness in patients with OSAS.
  • To compare subjective and objective measures of sleepiness between autoCPAP and fCPAP treatments over two years.

Main Methods:

  • A multicentre equivalence trial randomized 208 OSAS patients (median Epworth Sleepiness Score [ESS] 13, Apnoea/Hypopnoea Index 48.4/hour).
  • Patients were assigned to autoCPAP (5-15 mbar) or fCPAP (pressure set at autoCPAP's 90th percentile during adaptation).
  • Coprimary outcomes included changes in ESS and objective sleepiness (sleep resistance time) from baseline to 2 years, with predefined equivalence ranges.

Main Results:

  • After 2 years, both autoCPAP and fCPAP groups showed similar reductions in sleepiness (mean ESS change: -6.3 vs. -6.2).
  • Objective sleepiness also improved similarly, with increases in sleep resistance time (+8.3 min vs. +6.3 min).
  • Equivalence was confirmed within the specified ranges for both ESS and sleep resistance time; blood pressure and costs were also comparable.

Conclusions:

  • AutoCPAP and fCPAP demonstrate equivalent efficacy in improving subjective and objective sleepiness in OSAS patients over a 2-year period.
  • The findings support autoCPAP as a viable alternative to fCPAP for long-term OSAS management.
  • Treatment costs associated with both autoCPAP and fCPAP were found to be similar.