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Multinight CPAP for Sleep Apnea Patients

Primary Purpose

Sleep Apnea, Sleep Disordered Breathing

Status

Terminated

Phase

Not Applicable

Locations

United States

Study Type

Interventional

Intervention

CPAP machine with MNT algorithm

About this trial

This is an interventional diagnostic trial for Sleep Apnea focused on measuring Sleep Disordered Breathing, Sleep Apnea

Eligibility Criteria

18 Years - 85 Years (Adult, Older Adult)All SexesAccepts Healthy Volunteers

Inclusion Criteria:

> 18 years of age
No contradictions to Continuous Positive Airway Pressure (CPAP)
Able to provide consent

Exclusion Criteria:

° Vulnerable subjects

Sites / Locations

New York University School of Medicine

Arms of the Study

Arm 1

Arm Type

Experimental

Arm Label

MNT Algorithm

Arm Description

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.

Outcomes

Primary Outcome Measures

Difference in number of residual events between high and low pressure levels

Residual events are represented by a given sleep disordered breathing index SDBIndex

Pressure level obtained during the MNT Fast Track stage

Number of days required to reach Fast Track pressure

Number of times the algorithm returns to Slow Track from the Fast Track stage

Variance in average obstruction of the upper airway during sleep measured by Obstruction Index (OI)

Difference between pressure derived from multinight algorithm (PMNT) and Fast Track pressure

Difference between PMNT and sleep lab diagnosed CPAP pressure

Number of residual events while using the PMNT function

Secondary Outcome Measures

Average comfort rating using CPAP with multinight automated titration

Full Information

NCT ID

NCT02635100

First Posted

December 14, 2015

Last Updated

December 7, 2017

Sponsor

NYU Langone Health

Collaborators

Fisher and Paykel Healthcare

1. Study Identification

Unique Protocol Identification Number

NCT02635100

Brief Title

Multinight CPAP for Sleep Apnea Patients

Official Title

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

Study Type

Interventional

2. Study Status

Record Verification Date

December 2017

Overall Recruitment Status

Terminated

Why Stopped

PI has left the institution

Study Start Date

May 2015 (undefined)

Primary Completion Date

November 2016 (Actual)

Study Completion Date

November 2016 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title

Sponsor

Name of the Sponsor

NYU Langone Health

Collaborators

Fisher and Paykel Healthcare

4. Oversight

Studies a U.S. FDA-regulated Drug Product

Studies a U.S. FDA-regulated Device Product

Data Monitoring Committee

5. Study Description

Brief Summary

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.

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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study

Sleep Apnea, Sleep Disordered Breathing

Keywords

Sleep Disordered Breathing, Sleep Apnea

7. Study Design

Primary Purpose

Diagnostic

Study Phase

Not Applicable

Interventional Study Model

Single Group Assignment

Masking

None (Open Label)

Allocation

N/A

Enrollment

1 (Actual)

8. Arms, Groups, and Interventions

Arm Title

MNT Algorithm

Arm Type

Experimental

Arm Description

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.

Intervention Type

Other

Intervention Name(s)

CPAP machine with MNT algorithm

Other Intervention Name(s)

ICON PLUS

Intervention Description

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: Fast Track (FT) stage. Assesses if the algorithm reliably and timely reaches approximate therapeutic pressure levels. 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. Five days with standard auto titration. 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.

Primary Outcome Measure Information:

Title

Difference in number of residual events between high and low pressure levels

Description

Residual events are represented by a given sleep disordered breathing index SDBIndex

Time Frame

45 days

Title

Pressure level obtained during the MNT Fast Track stage

Time Frame

7 days

Title

Number of days required to reach Fast Track pressure

Time Frame

7 days

Title

Number of times the algorithm returns to Slow Track from the Fast Track stage

Time Frame

45 days

Title

Variance in average obstruction of the upper airway during sleep measured by Obstruction Index (OI)

Time Frame

3 hours

Title

Difference between pressure derived from multinight algorithm (PMNT) and Fast Track pressure

Time Frame

45 days

Title

Difference between PMNT and sleep lab diagnosed CPAP pressure

Time Frame

45 days

Title

Number of residual events while using the PMNT function

Time Frame

45 days

Secondary Outcome Measure Information:

Title

Average comfort rating using CPAP with multinight automated titration

Time Frame

45 days

10. Eligibility

Sex

All

Minimum Age & Unit of Time

18 Years

Maximum Age & Unit of Time

85 Years

Accepts Healthy Volunteers

Eligibility Criteria

Inclusion Criteria: > 18 years of age No contradictions to Continuous Positive Airway Pressure (CPAP) Able to provide consent Exclusion Criteria: ° Vulnerable subjects

Overall Study Officials:

First Name & Middle Initial & Last Name & Degree

David Rapoport, MD

Organizational Affiliation

NYU Langone Health

Official's Role

Principal Investigator

Facility Information:

Facility Name

New York University School of Medicine

City

New York

State/Province

New York

ZIP/Postal Code

10016

Country

United States

12. IPD Sharing Statement

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Multinight CPAP for Sleep Apnea Patients

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