Clinical trial NCT02365064: CPAP vs ASV for Insomnia
Official title: PAP to PAP: CPAP vs ASV for Insomnia Randomized Controlled Trial
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Insomnia
Sleep-Disordered Breathing
Lead sponsor: ResMed
Sponsor class: INDUSTRY
First posted: 2015-02-18
Enrollment: 78
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

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.

Eligibility criteria: 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

Primary outcomes:
measure: Insomnia Severity Index
timeFrame: Baseline and 4 months
Secondary outcomes:
measure: Sleep Quality Rating
timeFrame: Baseline and 4 months
measure: Global Morning Rating
timeFrame: 4 months
measure: Sleep Onset Latency
timeFrame: 4 months
measure: Wake After Sleep Onset (WASO)
timeFrame: 4 months
measure: Sleep Efficiency
timeFrame: 4 months
Other outcomes:
Locations:
city: Albuquerque
country: United States
facility: Maimonides Sleep Arts & Sciences
state: New Mexico
Study officials:
affiliation: Sleep & Human Health Institute
name: Barry Krakow, MD
role: PRINCIPAL_INVESTIGATOR
References:
citation: Krakow B, McIver ND, Ulibarri VA, Krakow J, Schrader RM. Prospective Randomized Controlled Trial on the Efficacy of Continuous Positive Airway Pressure and Adaptive Servo-Ventilation in the Treatment of Chronic Complex Insomnia. EClinicalMedicine. 2019 Aug 8;13:57-73. doi: 10.1016/j.eclinm.2019.06.011. eCollection 2019 Aug.