CPAP vs ASV for Insomnia

Patients presenting to the sleep clinic with a primary complaint of insomnia will be
potential participants for this study. Following diagnostic polysomnography (PSG) testing,
insomnia patients diagnosed with SDB and meeting inclusion criteria will be randomized to a
PAP treatment arm, CPAP or ASV. Participants will complete titration studies with their
assigned PAP mode and attend clinical follow-up appointments over a 14-16 week timeframe.
Titration PSG studies will assess PAP pressure needs to ensure that patients are receiving
optimal therapy at all times during this study. PAP adaptation barriers will be addressed as
they arise during the study, because it is important that participants are able to use PAP
therapy nightly during participation in this protocol. Baseline scores on insomnia severity,
sleep quality, subjective insomnia parameters, sleep related impairment, and quality of life
will be compared to outcome measures at the 4 month mark. Pre-treatment and post-treatment
objective improvements on sleep studies will also be compared including sleep breathing
indices, sleep consolidation indices, and objective data download information.

Inclusion Criteria:

- Primary complaint of insomnia when presenting at clinic

- Diagnosis of moderate to severe insomnia through the Insomnia Severity Index (ISI)
with a score ≥ 15

- Meet diagnostic criteria of Insomnia Disorder (per American Academy of Sleep Medicine)

- Diagnosis of SDB, either OSA as determined by an AHI ≥ 5 events/hour or UARS with a
RDI ≥ 15 events/hour and AHI < 5 events/hour

- Naïve to treatment for sleep-disordered breathing (SDB), including CPAP, APAP, ASV;
mandibular repositioning devices (MRDs), and any other nasal or oral therapy with a
primary indication of treating SDB

- Able to fully understand study information in English and sign informed consent

Exclusion Criteria:

- Primary complaint of sleep-disordered breathing or issues with apneas during sleep

- Severe respiratory disorder or severe sleep disorder such as restless leg syndrome
(RLS), idiopathic hypersomnia, or narcolepsy

- BMI > 30 kg/m2

- Epworth Sleepiness Scale (ESS) score ≥ 10

- Frequent napping behavior, such as a few times a week or more

- Anticipated changes to start or stop sedative or psychotropic medications during the
course of the trial

- Medical history of congestive heart failure (CHF) or other potentially unstable
cardiac disease as well as chronic lung diseases or other debilitating medical
conditions that manifest as more prominent in the patient's health compared to their
sleep complaints

- Daily use of opiate medications

- Known contraindications to PAP therapy as listed in the indication for use

- Requires a CPAP (fixed) pressure > 20 cm H2O

- Inability to comply with study procedures