Multinight CPAP for Sleep Apnea Patients

Not Applicable

Terminated

• Conditions: Sleep Disordered Breathing; Sleep Apnea
• Interventions: Other: CPAP machine with MNT algorithm

• Registration Number: NCT02635100
• Lead Sponsor: NYU Langone Health

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.

Basic Information
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Recruitment & Eligibility
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Study & Design
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Trial Locations

Study Timeline

• Study Start: 2015-05
• Study First Submitted: 2015-12-14
• Study First Submitted QC: 2015-12-15
• Study First Posted: 2015-12-18
• Primary Completion: 2016-11
• Study Completion: 2016-11
• Status Verified: 2017-12
• Last Update Submitted: 2017-12-07
• Last Update Posted: 2017-12-11

Recruitment & Eligibility

• Status: TERMINATED
• Sex: All
• Target Recruitment: 1

Inclusion Criteria

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

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Exclusion Criteria

° Vulnerable subjects

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Study & Design

• Study Type: INTERVENTIONAL
• Study Design: SINGLE_GROUP

Arm && Interventions

Group	Intervention	Description
MNT Algorithm	CPAP machine with 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.

Primary Outcome Measures

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

Secondary Outcome Measures

Name	Time	Method
Average comfort rating using CPAP with multinight automated titration	45 days

Trial Locations

Locations (1)

New York University School of Medicine; 🇺🇸 New York, New York, United States