IADR Abstract Archives
MAS and CPAP Monotherapy Versus Combination Therapy: a Clinical Trial
Objectives: To compare the alternating use of mandibular advancement splint (MAS) and continuous positive airway pressure (CPAP) with their simultaneous use (dual-therapy) and their conventional use (monotherapy) for obstructive sleep apnea management
Methods: This four-phase clinical trial aimed to compare the effects of 1-month CPAP, MAS, alternating therapy, and dual-therapy following optimal titration to both CPAP and MAS. Phase I and II were double-randomized cross-over, followed by observational (III) and dual-therapy phases (IV). Objective measures included CPAP pressure, adherence and oxygen desaturation index (ODI) 3%. Self-reported measures included Epworth Sleepiness Scale (ESS) and Functional Outcomes Sleep Questionnaire (FOSQ) scores.
Results: Thirteen participants completed phase IV. These were predominantly middle-aged (55±13years) Caucasian (62%) males (71%) with severe obstructive sleep apnea (apnea-hypopnea index= 33 events/hour). CPAP pressure requirements were reduced by dual-therapy compared to CPAP-monotherapy for the high pressure on CPAP-monotherapy (N=7) group (≥10cmH2O) p=0.04, but not for the total sample (p=0.25). CPAP-monotherapy, MAS-monotherapy, and dual-therapy significantly reduced ODI relative to baseline (p<0.001). CPAP-monotherapy and dual-therapy were more effective than MAS-monotherapy. Objective adherence was significantly less for CPAP-monotherapy compared to MAS-monotherapy and dual therapy, 5.8±1.7, 7.2±1.1, 6.7±1.7, and 7.1±1.1(h/night) for 1-month CPAP, MAS, observation, and dual-therapy respectively (p<0.001). Sleepiness was similar in all groups. MAS, observation and dual-therapy, but not CPAP resulted in significant improvement in FOSQ scores relative to baseline (p=0.001).
Conclusions: These results confirm that dual-therapy is beneficial for patients who require high CPAP pressure (≥10cmH2O) with CPAP-monotherapy. This trial also shows that both dual-therapy and the alternating use of therapies increase adherence to treatment.
Furthermore, both dual-therapy and alternating therapy are effective in reducing symptoms in patients who are highly symptomatic pre-treatment and for whom monotherapy is not sufficient to completely resolve symptoms, despite adequate appliance titration.
Methods: This four-phase clinical trial aimed to compare the effects of 1-month CPAP, MAS, alternating therapy, and dual-therapy following optimal titration to both CPAP and MAS. Phase I and II were double-randomized cross-over, followed by observational (III) and dual-therapy phases (IV). Objective measures included CPAP pressure, adherence and oxygen desaturation index (ODI) 3%. Self-reported measures included Epworth Sleepiness Scale (ESS) and Functional Outcomes Sleep Questionnaire (FOSQ) scores.
Results: Thirteen participants completed phase IV. These were predominantly middle-aged (55±13years) Caucasian (62%) males (71%) with severe obstructive sleep apnea (apnea-hypopnea index= 33 events/hour). CPAP pressure requirements were reduced by dual-therapy compared to CPAP-monotherapy for the high pressure on CPAP-monotherapy (N=7) group (≥10cmH2O) p=0.04, but not for the total sample (p=0.25). CPAP-monotherapy, MAS-monotherapy, and dual-therapy significantly reduced ODI relative to baseline (p<0.001). CPAP-monotherapy and dual-therapy were more effective than MAS-monotherapy. Objective adherence was significantly less for CPAP-monotherapy compared to MAS-monotherapy and dual therapy, 5.8±1.7, 7.2±1.1, 6.7±1.7, and 7.1±1.1(h/night) for 1-month CPAP, MAS, observation, and dual-therapy respectively (p<0.001). Sleepiness was similar in all groups. MAS, observation and dual-therapy, but not CPAP resulted in significant improvement in FOSQ scores relative to baseline (p=0.001).
Conclusions: These results confirm that dual-therapy is beneficial for patients who require high CPAP pressure (≥10cmH2O) with CPAP-monotherapy. This trial also shows that both dual-therapy and the alternating use of therapies increase adherence to treatment.
Furthermore, both dual-therapy and alternating therapy are effective in reducing symptoms in patients who are highly symptomatic pre-treatment and for whom monotherapy is not sufficient to completely resolve symptoms, despite adequate appliance titration.