CPAP vs ASV for Insomnia

Not Applicable

Completed

Brief Summary: The study will determine which of two different types of positive airway pressure (PAP therapy) modes are more effective in reducing sleep breathing events in chronic insomnia patients and in decreasing insomnia severity.

Detailed Description: 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.

Recruitment & Eligibility

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

Arm && Interventions

Group	Intervention	Description
Continuous Positive Airway Pressure	AirCurve 10 ASV	Continuous positive airway pressure (CPAP) intervention as active comparator. Provides a fixed pressure for both inspiration and expiration.
Adaptive Servo-Ventilation	AirCurve 10 ASV	Adaptive servo-ventilation (ASV) positive airway pressure as experimental intervention. Provides a higher pressure for inspiration and a lower pressure for expiration with changes in the pressure support level to meet a target minute ventilation.

Primary Outcome Measures

Name	Time	Method
Insomnia Severity Index	Baseline and 4 months	Change in insomnia severity from baseline to 4 months as measured by subjective questionnaire. The Insomnia Severity Index has seven questions. The seven answers are added up for a total score. Scores range from 0 - 28. A higher score indicates a more severe degree of insomnia.

Secondary Outcome Measures

Name	Time	Method
Global Morning Rating	4 months	Change in subjective rating from baseline to 4 months based on a 0-100% scale. Lower scores equal a more positive experience
Sleep Onset Latency	4 months	Change in from baseline to 4 months in sleep onset time (minutes)
Sleep Quality Rating	Baseline and 4 months	8 point Likert scale for change in subjective sleep quality from baseline to 4 months. Lower scores indicated more positive sleep quality. A score 0 indicates excellent sleep quality, and a score of 7 indicates very poor sleep quality
Wake After Sleep Onset (WASO)	4 months	Change from baseline to 4 months for WASO in minutes
Sleep Efficiency	4 months	Change from baseline to 4 months in sleep efficiency (total sleep time/time in bed)