Multinight CPAP for Sleep Apnea Patients

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
• Conditions: Sleep Apnea; Sleep Disordered Breathing
• Intervention / Treatment: Other: CPAP machine with MNT algorithm

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

Study Locations

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

Participation Criteria

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

How is the study designed?

Design Details

• Primary Purpose: Diagnostic
• Allocation: N/A
• Interventional Model: Single Group Assignment
• Masking: None (Open Label)

Number of Arms

1

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.

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

Secondary Outcome Measures

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

Collaborators and Investigators

• Sponsor: NYU Langone Health
• Collaborators: Fisher and Paykel Healthcare
• Investigators: Principal Investigator: David Rapoport, MD, NYU Langone Health

Study record dates

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

• Keywords: Sleep Apnea; Sleep Disordered Breathing
• Additional Relevant MeSH Terms: Pathologic Processes; Nervous System Diseases; Respiratory Tract Diseases; Respiration Disorders; Sleep Disorders, Intrinsic; Dyssomnias; Sleep Wake Disorders; Signs and Symptoms, Respiratory; Sleep Apnea Syndromes; Respiratory Aspiration; Apnea
• Other Study ID Numbers: 14-00605

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No