A randomized controlled trial of CBT-I and PAP for obstructive sleep apnea and comorbid insomnia : main outcomes from the MATRICS study

Study Objectives -- To investigate treatment models using cognitive behavioral therapy for insomnia (CBT-I) and positive airway pressure (PAP) for people with obstructive sleep apnea (OSA) and comorbid insomnia. Methods -- 121 adults with OSA and comorbid insomnia were randomized to receive CBT-I followed by PAP, CBT-I concurrent with PAP, or PAP only. PAP was delivered following standard clinical procedures for in-lab titration and home setup and CBT-I was delivered in four individual sessions. The primary outcome measure was PAP adherence across the first 90 days, with regular PAP use (≥4 h on ≥70% of nights during a 30-day period) serving as the clinical endpoint. The secondary outcome measures were the Pittsburgh Sleep Quality Index (PSQI) and Insomnia Severity Index (ISI) with good sleeper (PSQI 7) serving as the clinical endpoints. Results -- No significant differences were found between the concomitant treatment arms and PAP only on PAP adherence measures, including the percentage of participants who met the clinical endpoint. Compared to PAP alone, the concomitant treatment arms reported a significantly greater reduction from baseline on the ISI (p = .0009) and had a greater percentage of participants who were good sleepers (p = .044) and remitters (p = .008). No significant differences were found between the sequential and concurrent treatment models on any outcome measure. Conclusions -- The findings from this study indicate that combining CBT-I with PAP is superior to PAP alone on insomnia outcomes but does not significantly improve adherence to PAP

A randomized controlled trial of CBT-I and PAP for obstructive sleep apnea and comorbid insomnia : effects on nocturnal sleep and daytime performance

This study examines the impact of cognitive-behavioral therapy for insomnia (CBT-I) and positive airway pressure (PAP) therapy for comorbid insomnia and sleep apnea (COMISA) on nocturnal sleep and daytime functioning. A partial factorial design was used to examine treatment pathways with CBT-I and PAP and the relative benefits of each treatment. 118 individuals with COMISA were randomized to receive CBT-I followed by PAP, self-monitoring followed by CBT-I concurrent with PAP, or self-monitoring followed by PAP only. Participants were assessed at baseline, PAP titration, and 30- and 90-days after PAP initiation. Outcome measures included sleep diary- and actigraphy-measured sleep, Flinders Fatigue Scale(FFS), Epworth Sleepiness Scale(ESS), Functional Outcome of Sleep Questionnaire(FOSQ), and cognitive-emotional measures. A main effect of time was found on diary-measured sleep parameter (decreased sleep onset latency[SOL] and wake after sleep onset[WASO]; increased total sleep time[TST] and sleep efficiency[SE]) and actigraphy-measured sleep parameter (decreased WASO; increased SE) and daytime functioning (reduced ESS, FFS; increased FOSQ) across all arms (all p< 0.05). Significant interactions and planned contrast comparisons revealed that CBT-I was superior to PAP and self-monitoring on reducing diary-measured SOL and WASO and increasing SE; as well as improving FOSQ and FFS compared to self-monitoring. Improvements in sleep and daytime functioning were found with PAP alone or concomitant with CBT-I. However, more rapid effects were observed on subjective sleep and daytime performance when receiving CBT-I regardless of when it was initiated. Therefore, concomitant treatment appears to be a favorable approach to accelerate treatment outcomes. Registry: ClinicalTtrials.gov; Identifier: NCT01785303