Protocol timeline: patient pathway from referral through study exit.
Abbreviations: MSAS — Maimonides Sleep Arts & Sciences; OSA — obstructive sleep apnea; UARS — upper airway resistance syndrome; PSG — Polysomnography Sleep Test; ISI — Insomnia Severity Index; ESS — Epworth Sleepiness Scale; III — Insomnia Impairment Index; FSS — Fatigue Severity Scale; FOSQ-10 — Functional Outcomes of Sleep Questionnaire Short Form; QLESQ — Quality of Life Enjoyment and Satisfaction Questionnaire Summary; DxPSG — Diagnostic Polysomnography Sleep Test; MD — medical director; CPAP — continuous positive airway pressure; ASV — adaptive servo-ventilation; SQ-Lik — sleep quality (Likert scale); SQ-Pct — sleep quality (percent scale); ODD — objective data download.
Footnote:
aIntake included ISI, ESS, III, FSS, FOSQ-10, QLESQ. Potentially eligible patients were informed “the protocol does not involve drugs, placebos or deception; it is a randomized controlled trial of two different techniques to treat chronic insomnia,” but no further details were provided about treatment.
bOnline sleep diary completed daily via home computer or smart phone throughout the study and included two questions regarding subjective sleep quality, SQ-Lik and SQ-Pct, as well as subjective sleep indices. Pre-treatment sleep diary completed for 7 consecutive days prior to first titration.
cPatients encouraged to use PAP nightly; the protocol was designed for patients to quickly attain or approach standard PAP compliance metrics to ensure final results would measure efficacy among two samples of regular users. Adaptation to CPAP and ASV may follow different courses, because CPAP users must contend with EPI and central apneas from the outset; whereas ASV patients may experience immediate alleviation of EPI as well as fewer or no central apneas. However, ASV patients may struggle with the constant auto-adjusting changes embedded within this technology, which makes some individuals feel as if they are losing control over their breathing.
dCompletion of protocol granted patient ownership of the PAP device and transportation reimbursement ($85).