Controlled Clinical Trial
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A Novel Therapy for Chronic Sleep-Onset Insomnia: A Retrospective, Nonrandomized Controlled Study of Auto-Adjusting, Dual-Level, Positive Airway Pressure Technology.

Objective: Evidence indicates that behavioral or drug therapy may not target underlying pathophysiologic mechanisms for chronic insomnia, possibly due to previously unrecognized high rates (30%-90%) of sleep apnea in chronic insomnia patients. Although treatment studies with positive airway pressure (PAP) demonstrate decreased severity of chronic sleep maintenance insomnia in patients with co-occurring sleep apnea, sleep-onset insomnia has not shown similar results. We hypothesized advanced PAP technology would be associated with decreased sleep-onset insomnia severity in a sample of predominantly psychiatric patients with comorbid sleep apnea.

Methods: We reviewed charts of 74 severe sleep-onset insomnia patients seen from March 2011 to August 2015, all meeting American Academy of Sleep Medicine Work Group criteria for a chronic insomnia disorder and all affirming behavioral and psychological origins for insomnia (averaging 10 of 18 indicators/patient), as well as averaging 2 or more psychiatric symptoms or conditions: depression (65.2%), anxiety (41.9%), traumatic exposure (35.1%), claustrophobia (29.7%), panic attacks (28.4%), and posttraumatic stress disorder (20.3%). All patients failed continuous or bilevel PAP and were manually titrated with auto-adjusting PAP modes (auto-bilevel and adaptive-servo ventilation). At 1-year follow-up, patients were compared through nonrandom assignment on the basis of a PAP compliance metric of > 20 h/wk (56 PAP users) versus < 20 h/wk (18 partial PAP users).

Results: PAP users showed significantly greater decreases in global insomnia severity (Hedges' g = 1.72) and sleep-onset insomnia (g = 2.07) compared to partial users (g = 1.04 and 0.91, respectively). Both global and sleep-onset insomnia severity decreased below moderate levels in PAP users compared to partial users whose outcomes persisted at moderately severe levels.

Conclusions: In a nonrandomized controlled retrospective study, advanced PAP technology (both auto-bilevel and adaptive servo-ventilation) were associated with large decreases in insomnia severity for sleep-onset insomnia patients who strongly believed psychological factors caused their sleeplessness. PAP treatment of sleep-onset insomnia merits further investigation.

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