Sleep ApneaNCT02635100
Multinight CPAP for Sleep Apnea Patients
A study testing CPAP machine with MNT algorithm in people with Sleep Apnea and Sleep Disordered Breathing, run by NYU Langone Health at 1 site in United States.
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. Read more about this study
- Who is it for?
- Ages 18 to 85 yearsHealthy volunteers can take part
- Conditions the study is for
- Sleep Apnea, Sleep Disordered Breathing
- What is being tested?
- CPAP machine with MNT algorithm
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 1 participants
- Where
- 1 siteUnited States
- Study dates
- May 2015to Nov 2016
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 85 years
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
Who may be able to join
- > 18 years of age
- No contradictions to Continuous Positive Airway Pressure (CPAP)
- Able to provide consent
Who cannot join
- ° Vulnerable subjects
Trial locations and contacts
1 site in 1 country.
United States1 site
New York University School of Medicine
New York, New York, 10016
About this study
Official title: Evaluation of a Multinight (MNT) CPAP Titration Algorithm in Patients With Sleep Apnea.
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.
Read the 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:
- 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.
- Conditions
- Sleep Apnea, Sleep Disordered Breathing
- Being tested
- CPAP machine with MNT algorithm
- Keywords
- Sleep Disordered Breathing, Sleep Apnea
- Medical subject headings
- Sleep Apnea Syndromes
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
CPAP machine with MNT algorithmOther
Also called ICON PLUS
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.
| Study group | Role | What they receive |
|---|---|---|
| MNT Algorithm | Experimental | 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. Receives: Other: CPAP machine with MNT algorithm |
What is being measured
The primary outcome is the main question the study is designed to answer.
Difference in number of residual events between high and low pressure levels
Residual events are represented by a given sleep disordered breathing index SDBIndex
Measured: 45 days
Pressure level obtained during the MNT Fast Track stage
Measured: 7 days
Number of days required to reach Fast Track pressure
Measured: 7 days
Number of times the algorithm returns to Slow Track from the Fast Track stage
Measured: 45 days
Variance in average obstruction of the upper airway during sleep measured by Obstruction Index (OI)
Measured: 3 hours
Difference between pressure derived from multinight algorithm (PMNT) and Fast Track pressure
Measured: 45 days
Difference between PMNT and sleep lab diagnosed CPAP pressure
Measured: 45 days
Number of residual events while using the PMNT function
Measured: 45 days
Secondary outcomes (1)
Average comfort rating using CPAP with multinight automated titration
Measured: 45 days
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted18 Dec 2015 (estimated)
- Study startMay 2015
- Primary completionNov 2016
- Study completionNov 2016
Why it stopped: PI has left the institution
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Sleep ApneaStudies of the same condition, open and under way.
- More trials run by NYU Langone HealthThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Diagnosis
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 1 participants (actual)
Sponsor and investigators
- Lead sponsor
- NYU Langone Health
- Sponsor type
- University, hospital or other
- Collaborators
- Fisher and Paykel Healthcare
- Responsible party
- Sponsor
- Investigators
- David Rapoport, MD, Principal investigator, NYU Langone Health
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02635100
- Sponsor's protocol ID
- 14-00605
- Status last verified
- Dec 2017
- First submitted
- 14 Dec 2015
- Last updated
- 11 Dec 2017
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 11 Dec 2017. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Evaluation of a Multinight (MNT) CPAP Titration Algorithm in Patients With Sleep Apnea.
- ClinicalTrials.gov ID
- NCT02635100
- Acronym / sponsor ID
- 14-00605
- Conditions
- Sleep Apnea, Sleep Disordered Breathing
- Keywords
- Sleep Disordered Breathing, Sleep Apnea
- Study type
- Interventional
- Recruitment status
- TerminatedReason stopped: PI has left the institution
- Enrolment
- 1 participants (actual)
- Lead sponsor
- NYU Langone HealthUniversity, hospital or other
- Collaborators
- Fisher and Paykel Healthcare
- Study start
- May 2015
- Primary completion
- Nov 2016 (actual)
- Study completion
- Nov 2016 (actual)
- First posted
- 18 Dec 2015 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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:
- 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 design
- Primary purpose
- Diagnosis
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| MNT Algorithm | Experimental | Other: CPAP machine with MNT algorithmAll 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. |
Who may qualify
- Ages
- 18 to 85 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (3 listed)
- > 18 years of age
- No contradictions to Continuous Positive Airway Pressure (CPAP)
- Able to provide consent
Key exclusion criteria (1 listed)
- ° Vulnerable subjects
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| CPAP machine with MNT algorithmAlso: ICON PLUSThe 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. | Other | MNT Algorithm |
Primary outcome
Difference in number of residual events between high and low pressure levels
Time frame: 45 days
Residual events are represented by a given sleep disordered breathing index SDBIndex
Pressure level obtained during the MNT Fast Track stage
Time frame: 7 days
Number of days required to reach Fast Track pressure
Time frame: 7 days
Number of times the algorithm returns to Slow Track from the Fast Track stage
Time frame: 45 days
Variance in average obstruction of the upper airway during sleep measured by Obstruction Index (OI)
Time frame: 3 hours
Difference between pressure derived from multinight algorithm (PMNT) and Fast Track pressure
Time frame: 45 days
Difference between PMNT and sleep lab diagnosed CPAP pressure
Time frame: 45 days
Number of residual events while using the PMNT function
Time frame: 45 days
1 secondary outcome
Average comfort rating using CPAP with multinight automated titration
Time frame: 45 days
Results and safety
The study was stopped early (reason given: PI has left the institution). Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 11 Dec 2017.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
David Rapoport, MD principal investigator
NYU Langone Health
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing CPAP machine with MNT algorithm in people with Sleep Apnea and Sleep Disordered Breathing, run by NYU Langone Health at 1 site in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 3 inclusion and 1 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: stopped early, as of the sponsor's last update on 11 Dec 2017. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study was stopped early (reason given: PI has left the institution). Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Difference in number of residual events between high and low pressure levels (time frame: 45 days). The study lists 8 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 11 Dec 2017.