Multinight CPAP for Sleep Apnea Patients

Study Overview
=================
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.

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

Conditions
-----------------
Sleep Apnea, Sleep Disordered Breathing

Intervention / Treatment
-----------------
* Other: CPAP machine with MNT algorithm


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: > 18 years of age No contradictions to Continuous Positive Airway Pressure (CPAP) Able to provide consent Exclusion Criteria: ° Vulnerable subjects

Ages Eligible for Study
-----------------
Minimum Age: 18 Years
Maximum Age: 85 Years

Sexes Eligible for Study
-----------------
All

Accepts Healthy Volunteers
-----------------
Accepts Healthy Volunteers

Study Plan
=================
How is the study designed?
-----------------

Design Details

Primary Purpose: Diagnostic
Intervention Model: Single Group Assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: MNT Algorithm<br>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. | Other: CPAP machine with MNT algorithm<br>* 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.<br>* Other names: ICON PLUS;|

What is the study measuring?
-----------------
Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| 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 | 
| 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 | 
| Number of residual events while using the PMNT function |  | 45 days | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Average comfort rating using CPAP with multinight automated titration |  | 45 days | 

 Terms related to the study
=================
Keywords Provided by Centre Hospitalier Valida
-----------------
Sleep Disordered Breathing, Sleep Apnea