CPAP vs ASV for Insomnia

Completed · Not applicable

Conditions studied: Insomnia, Sleep-Disordered Breathing

In brief

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.

Key facts

Study ID

NCT02365064

Run by

ResMed

People needed

78

Starts

2015-02-01

Expected to finish

2017-12-01

Last updated by the study team

2021-09-09

Who can join

Age: 18 and older. Sex: any. Healthy volunteers: not accepted.

You may qualify if…

• 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

You may not qualify if…

• 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

Where it is running

• Maimonides Sleep Arts & Sciences — Albuquerque, New Mexico, United States

Full record on ClinicalTrials.gov

Trial information comes from ClinicalTrials.gov and is refreshed daily. TrialsForMe does not provide medical care and does not run the studies it lists.