Ignite Creation Date:
2024-05-06 @ 7:57 AM
Last Modification Date:
2024-10-26 @ 11:54 AM
Study NCT ID:
NCT02635100
Status:
TERMINATED
Last Update Posted:
2017-12-11
First Post:
2015-12-14
Brief Title:
Multinight CPAP for Sleep Apnea Patients
Sponsor:
NYU Langone Health
Organization:
NYU Langone Health
Study Overview
Official Title:
Evaluation of a Multinight MNT CPAP Titration Algorithm in Patients With Sleep Apnea
Status:
TERMINATED
Status Verified Date:
2017-12
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
PI has left the institution
Has Expanded Access:
False
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
None
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 nosemouth
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
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 Oversight
Has Oversight DMC:
None
Is a FDA Regulated Drug?:
False
Is a FDA Regulated Device?:
False
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
None
Is an FDA AA801 Violation?:
None