Multinight CPAP for Sleep Apnea Patients

NYU Langone Health

Status: Terminated

Conditions: Sleep Disordered Breathing; Sleep Apnea

Treatments: Other: CPAP machine with MNT algorithm

Study type: Interventional

Funder types: Other; Industry

Identifiers

NCT02635100

14-00605

Details and patient eligibility

About

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.

Full 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.

Enrollment: 1 patient

Sex: All

Ages: 18 to 85 years old

Volunteers: Accepts Healthy Volunteers

Inclusion criteria

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

Exclusion criteria

° Vulnerable subjects

Trial design

Primary purpose: Diagnostic

Allocation: N/A

Interventional model: Single Group Assignment

Masking: None (Open label)

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1 participants in 1 patient group

MNT Algorithm

Experimental group

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.

Treatment:

Other: CPAP machine with MNT algorithm