- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT02635100
Multinight CPAP for Sleep Apnea Patients
Evaluation of a Multinight (MNT) CPAP Titration Algorithm in Patients With Sleep Apnea.
Study Overview
Status
Conditions
Intervention / Treatment
Detailed Description
The primary purpose of this study is to evaluate the multinight (MNT) algorithm on patients with Obstructive Sleep Apnea (OSA) over 45 nights while using a CPAP machine at home. The researchers are evaluating the performance of the existing algorithm as well as capturing the data to make enhancements.
Two main stages of this algorithm will be assessed:
i. Fast Track (FT) stage. In the FT stage the aim is to assess if the algorithm reliably and timely reaches approximate therapeutic pressure levels.
ii. Slow Titration (ST). In the Slow Titration stage the aim is to assess if data samples have been appropriately collected in a pressure range so that the therapeutic pressure can be inferred according to the algorithm proposed.
Study Type
Enrollment (Actual)
Phase
- Not Applicable
Contacts and Locations
Study Locations
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New York
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New York, New York, United States, 10016
- New York University School of Medicine
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Participation Criteria
Eligibility Criteria
Ages Eligible for Study
Accepts Healthy Volunteers
Genders Eligible for Study
Description
Inclusion Criteria:
- > 18 years of age
- No contradictions to Continuous Positive Airway Pressure (CPAP)
- Able to provide consent
Exclusion Criteria:
° Vulnerable subjects
Study Plan
How is the study designed?
Design Details
- Primary Purpose: Diagnostic
- Allocation: N/A
- Interventional Model: Single Group Assignment
- Masking: None (Open Label)
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
---|---|
Experimental: MNT Algorithm
All participants will be monitored using an existing (FDA approved) CPAP machine that has been modified to be externally controlled by a computer with the MNT algorithm, for titration.
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The multinight (MNT) algorithm will be evaluated on patients with Obstructive Sleep Apnea (OSA) over multiple nights while using CPAP in the home for a total of 45 days. In particular the main goal is to assess the behavior of the two main stages of the algorithm:
Other Names:
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What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
Difference in number of residual events between high and low pressure levels
Time Frame: 45 days
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Residual events are represented by a given sleep disordered breathing index SDBIndex
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45 days
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Pressure level obtained during the MNT Fast Track stage
Time Frame: 7 days
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7 days
|
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Number of days required to reach Fast Track pressure
Time Frame: 7 days
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7 days
|
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Number of times the algorithm returns to Slow Track from the Fast Track stage
Time Frame: 45 days
|
45 days
|
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Variance in average obstruction of the upper airway during sleep measured by Obstruction Index (OI)
Time Frame: 3 hours
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3 hours
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Difference between pressure derived from multinight algorithm (PMNT) and Fast Track pressure
Time Frame: 45 days
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45 days
|
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Difference between PMNT and sleep lab diagnosed CPAP pressure
Time Frame: 45 days
|
45 days
|
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Number of residual events while using the PMNT function
Time Frame: 45 days
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45 days
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Secondary Outcome Measures
Outcome Measure |
Time Frame |
---|---|
Average comfort rating using CPAP with multinight automated titration
Time Frame: 45 days
|
45 days
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Collaborators and Investigators
Sponsor
Collaborators
Investigators
- Principal Investigator: David Rapoport, MD, NYU Langone Health
Study record dates
Study Major Dates
Study Start
Primary Completion (Actual)
Study Completion (Actual)
Study Registration Dates
First Submitted
First Submitted That Met QC Criteria
First Posted (Estimate)
Study Record Updates
Last Update Posted (Actual)
Last Update Submitted That Met QC Criteria
Last Verified
More Information
Terms related to this study
Keywords
Additional Relevant MeSH Terms
Other Study ID Numbers
- 14-00605
Drug and device information, study documents
Studies a U.S. FDA-regulated drug product
Studies a U.S. FDA-regulated device product
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
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