Sleep Apnea, Sleep Disordered Breathing
Conditions
Keywords
Sleep Disordered Breathing, Sleep Apnea
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.
Interventions
OTHERCPAP 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: 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.
Sponsors
Fisher and Paykel Healthcare
NYU Langone Health
Study design
Allocation
NA
Intervention model
SINGLE_GROUP
Primary purpose
DIAGNOSTIC
Masking
NONE
Eligibility
Sex/Gender
ALL
Age
18 Years to 85 Years
Healthy volunteers
Yes
Inclusion criteria
* \> 18 years of age * No contradictions to Continuous Positive Airway Pressure (CPAP) * Able to provide consent
Exclusion criteria
° Vulnerable subjects
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Number of residual events while using the PMNT function | 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 |
| 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 | — |
Secondary
| Measure | Time frame |
|---|---|
| Average comfort rating using CPAP with multinight automated titration | 45 days |
Countries
United States
Outcome results
None listed