Multinight CPAP for Sleep Apnea Patients

December 7, 2017 updated by: NYU Langone Health

Evaluation of a Multinight (MNT) CPAP Titration Algorithm in Patients With Sleep Apnea.

Obstructive sleep apnea (OSA) is a prevalent disorders characterized by intermittent obstructions of the upper airway during sleep. Continuous Positive Airway Pressure (CPAP) has been shown to be the most efficacious treatment for OSA. It consists of a small device that provides positive airway pressure delivered by a mask attached to the patients nose/mouth.

Study Overview

Status

Terminated

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

Interventional

Enrollment (Actual)

1

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

    • New York
      • New York, New York, United States, 10016
        • New York University School of Medicine

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years to 85 years (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

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

This section provides details of the study plan, including how the study is designed and what the study is measuring.

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.

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:

  1. Fast Track (FT) stage. Assesses if the algorithm reliably and timely reaches approximate therapeutic pressure levels.
  2. Slow Titration (ST) stage.Assesses if data samples are appropriately collected in a pressure range so that the therapeutic pressure can be inferred according to the algorithm proposed.

    1. Five days with standard auto titration.
    2. MNT algorithm : 7 days (maximum) with Fast Track mode, 27 days (maximum) in Slow Titration mode. After PMNT is found, the device remains at PMNT for 5 sessions. Total approximately 45 days.
Other Names:
  • ICON PLUS

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
Residual events are represented by a given sleep disordered breathing index SDBIndex
45 days
Pressure level obtained during the MNT Fast Track stage
Time Frame: 7 days
7 days
Number of days required to reach Fast Track pressure
Time Frame: 7 days
7 days
Number of times the algorithm returns to Slow Track from the Fast Track stage
Time Frame: 45 days
45 days
Variance in average obstruction of the upper airway during sleep measured by Obstruction Index (OI)
Time Frame: 3 hours
3 hours
Difference between pressure derived from multinight algorithm (PMNT) and Fast Track pressure
Time Frame: 45 days
45 days
Difference between PMNT and sleep lab diagnosed CPAP pressure
Time Frame: 45 days
45 days
Number of residual events while using the PMNT function
Time Frame: 45 days
45 days

Secondary Outcome Measures

Outcome Measure
Time Frame
Average comfort rating using CPAP with multinight automated titration
Time Frame: 45 days
45 days

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Investigators

  • Principal Investigator: David Rapoport, MD, NYU Langone Health

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

May 1, 2015

Primary Completion (Actual)

November 1, 2016

Study Completion (Actual)

November 1, 2016

Study Registration Dates

First Submitted

December 14, 2015

First Submitted That Met QC Criteria

December 15, 2015

First Posted (Estimate)

December 18, 2015

Study Record Updates

Last Update Posted (Actual)

December 11, 2017

Last Update Submitted That Met QC Criteria

December 7, 2017

Last Verified

December 1, 2017

More Information

Terms related to this study

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

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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