NCT02365064

CPAP vs ASV for Insomnia

PAP to PAP: CPAP vs ASV for Insomnia Randomized Controlled Trial

• Status: Completed
• Phase: N/A
• Study type: Interventional
• Enrollment: 78 (actual)
• Sponsor: ResMed · Industry
• Sex: All
• Age: 18 Years
• Healthy volunteers: Not accepted

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.

Conditions

• Insomnia
• Sleep-Disordered Breathing

Interventions

Type	Name	Description
DEVICE	AirCurve 10 ASV	Device is able to provide both ASV therapy and CPAP therapy modes.

Timeline

• Start date: 2015-02-01
• Primary completion: 2017-08-01
• Completion: 2017-12-01
• First posted: 2015-02-18
• Last updated: 2021-09-09
• Results posted: 2021-09-09

Locations

1 site across 1 country: United States