Multinight CPAP for Sleep Apnea Patients

Sleep Apnea Clinical Trial

Official title:

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

Clinical Trial Details — Status: Terminated

Administrative data

• NCT number: NCT02635100
• Other study ID #: 14-00605
• Status: Terminated
• Phase: N/A
• First received: December 14, 2015
• Last updated: December 7, 2017
• Start date: May 2015
• Est. completion date: November 2016

Study information

• Verified date: December 2017
• Source: New York University School of Medicine
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Terminated
• Enrollment: 1
• Est. completion date: November 2016
• Est. primary completion date: November 2016
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: All
• Age group: 18 Years to 85 Years

Eligibility

Inclusion Criteria:

• > 18 years of age

• No contradictions to Continuous Positive Airway Pressure (CPAP)

• Able to provide consent

Exclusion Criteria:

° Vulnerable subjects

Related Conditions & MeSH terms

• Apnea
• Respiratory Aspiration
• Sleep Apnea
• Sleep Apnea Syndromes
• Sleep Disordered Breathing

Intervention

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.

Locations

Country	Name	City	State
United States	New York University School of Medicine	New York	New York

Sponsors (2)

Lead Sponsor	Collaborator
New York University School of Medicine	Fisher and Paykel Healthcare

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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
Primary	Pressure level obtained during the MNT Fast Track stage		7 days
Primary	Number of days required to reach Fast Track pressure		7 days
Primary	Number of times the algorithm returns to Slow Track from the Fast Track stage		45 days
Primary	Variance in average obstruction of the upper airway during sleep measured by Obstruction Index (OI)		3 hours
Primary	Difference between pressure derived from multinight algorithm (PMNT) and Fast Track pressure		45 days
Primary	Difference between PMNT and sleep lab diagnosed CPAP pressure		45 days
Primary	Number of residual events while using the PMNT function		45 days
Secondary	Average comfort rating using CPAP with multinight automated titration		45 days