Health-related quality of life and sleep quality after 12 months of treatment in non-severe obstructive sleep apnea: A randomized clinical trial with Continuous Positive Airway Pressure and Mandibular Advancement Splints

Abstract

In this randomized controlled trial, patients with non-severe obstructive sleep apnea (OSA) were treated with continuous positive airway pressure (CPAP) or a twin block mandibular advancement splint (MAS). The primary objective was to compare how CPAP and MAS treatments change the health-related quality of life (HRQoL) and self-reported sleep quality of patients after 12 months of treatment. In total, 104 patients were recruited: 55 were allocated to the CPAP-treatment group and 49 to the MAS-treatment group. We used the SF36 questionnaire to evaluate HRQoL and the Pittsburgh Sleep Quality Index (PSQI) to evaluate sleep quality. All patients were included in the intention-to-treat analyses. These analyses showed improvements in the SF36 physical component score (from 48.8 ± 7.6 at baseline to 50.5 ± 8.0 at follow-up, <i>p</i> = 0.03) in the CPAP treatment group and in the mental component score (from 44.9 ± 12.1 to 49.3 ± 9.2, <i>p</i> = 0.009) in the MAS treatment group. The PSQI global score improved in both the CPAP (from 7.7 ± 3.5 to 6.6 ± 2.9, <i>p</i> = 0.006) and the MAS (8.0 ± 3.1 to 6.1 ± 2.6, <i>p</i> < 0.001) treatment group. No difference was found between treatment groups in any of the SF36 scores or PSQI global score at the final follow-up (<i>p</i> > 0.05) in any analysis. The improvement in the SF36 vitality domain moderately correlated to the improvement in the PSQI global score in both groups (CPAP: |<i>r</i>| = 0.47, p < 0.001; MAS: |<i>r</i>| = 0.36, p = 0.01). In the MAS treatment group, we also found a weak correlation between improvements in the SF36 mental component score and PSQI global score (|<i>r</i>| = 0.28, <i>p</i> = 0.05). In conclusion, CPAP and MAS treatments lead to similar improvements in the HRQoL and self-reported sleep quality in non-severe OSA. Improvements in aspects of HRQoL seems to be moderately correlated to the self-reported sleep quality in both CPAP and MAS treatment.