Multinight CPAP for Sleep Apnea Patients

NCT02635100 | Terminated

• 1 other identifier: 14-00605
• Study Type: interventional
• Target: 1
• Locations: 1 country
• Sites: 1

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.

Conditions

Sleep Apnea; Sleep Disordered Breathing

Keywords

Sleep Disordered Breathing; Sleep Apnea

Outcome Measures

Primary Outcomes (8)

• 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 Outcomes (1)

• Average comfort rating using CPAP with multinight automated titration

  45 days

Study Arms (1)

MNT Algorithm

EXPERIMENTAL

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

Interventions

CPAP machine with MNT algorithm OTHER

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.

Also known as: ICON PLUS

MNT Algorithm

Eligibility Criteria

• Age: 18 Years - 85 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

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

You may not qualify if:

• ° Vulnerable subjects

Sponsors & Collaborators

• NYU Langone Health: lead
• Fisher and Paykel Healthcare: collaborator

Study Sites (1)

New York University School of Medicine

New York, New York, 10016, United States

Location

MeSH Terms

Conditions

Sleep Apnea Syndromes

Condition Hierarchy (Ancestors)

Apnea; Respiration Disorders; Respiratory Tract Diseases; Sleep Disorders, Intrinsic; Dyssomnias; Sleep Wake Disorders; Nervous System Diseases

Study Officials

• David Rapoport, MD

  NYU Langone Health

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NA
• Masking: NONE
• Purpose: DIAGNOSTIC
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: December 14, 2015
• First Posted: December 18, 2015
• Study Start: May 1, 2015
• Primary Completion: November 1, 2016
• Study Completion: November 1, 2016
• Last Updated: December 11, 2017

Record last verified: 2017-12

Locations

US (1)