Maimonides Sleep Arts & Sciences
Albuquerque, New Mexico, 87109, United States
NCT Number: NCT02365064
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.
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Notify Me18 year and older
All sexes
Interventional
Not applicable
Albuquerque, New Mexico, 87109, United States
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.
Healthy volunteers accepted: No
Only the study team can determine whether someone qualifies for participation.
Inclusion criteria
Exclusion criteria
Device is able to provide both ASV therapy and CPAP therapy modes.
Other names: VPAP Adapt, AutoSet CS2
Time frame: 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.
Time frame: 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
Time frame: 4 months
Change in subjective rating from baseline to 4 months based on a 0-100% scale. Lower scores equal a more positive experience
Time frame: 4 months
Change in from baseline to 4 months in sleep onset time (minutes)
Time frame: 4 months
Change from baseline to 4 months for WASO in minutes
Time frame: 4 months
Change from baseline to 4 months in sleep efficiency (total sleep time/time in bed)
ResMed
Industry
PAP to PAP: CPAP vs ASV for Insomnia Randomized Controlled Trial
Acronym: P2P
OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.
View the official ClinicalTrials.gov record (opens in a new tab)This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.
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