Sleep Apnea, Mixed Central and ObstructiveNCT04873024
Prevention of Airway Obstruction Events
A study testing cMAP Flow V 2.0 in people with Sleep Apnea, Mixed Central and Obstructive, run by NovaResp Technologies Inc at 1 site in Canada.
Trial summary
The standard for treatment for people suffering from obstructive sleep apnea (OSA) syndrome involves the use of Continuous, or Automatic Positive Airway Pressure (CPAP, APAP) machines, which work by delivering air via tubing and mask to a patient at pressures of up to 20cmH2O. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Sleep Apnea, Mixed Central and Obstructive
- What is being tested?
- cMAP Flow V 2.0
- Type of treatment
- Medical device
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 15 participants
- Where
- 1 siteCanada
- Study dates
- 1 Dec 2021to 12 Aug 2022
- 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 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- No history of self-reported cardiovascular or neurological issues
- Must be a current PAP machine user.
- Must have used PAP machines for more than 4 months.
- Must be at least 18 years old
- Must be able to comply with all study requirements as outlined in the consent form
- Must be able to understand English and be willing to provide written informed consent
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- For all nights of the study, participant must be willing to lend their personal PAP device for inspection.
- Must be willing to have their CPAP SD memory card analyzed by OSCAR to determine their average OAI over the past 30 days of use.
- For the low OAI group, participants must have an average OAI between 0.8 - 2.99 and AHI < 5.0 in the past 30 days, which would result in at least one obstructive apnea every two hours each night.
- For the high OAI group, participants must have an average OAI ≥ 3.0 and AHI ≥ 5.0 in the past 30 days, which would result in around 5 obstructive apneas every hour each night.
Who cannot join
- Subjects actively using bi-level PAP or require oxygen therapy
- History of severe cardiovascular disease, including NYHA Class III or IV heart failure, CAD with angina, or MI/stroke within past 6 months
- Subjects who are medically complicated or who are medically unstable (i.e. cancer, dementia, unstable cardiac or respiratory disease, or unstable psychiatric illness)
- Potential sleep apnea complications that in the opinion of the clinician may affect the health and safety of the participant
- Subjects exhibiting any flu-like or any upper airway tract infection symptoms at the time of assessment
- Pregnant (confirmed verbally)
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- Inability or unwillingness of individual to give written informed consent
- Has received bariatric surgery
- All participants currently screened, enrolled, and consented who have not yet had all overnight testing done, AND who have an OAI < 3.0 and AHI < 5.0, will be excluded from the study, as this group has been fully enrolled to date.
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Real-time Prediction and Prevention of Apnea Events on PAP Machines in an Interventional Study
The standard for treatment for people suffering from obstructive sleep apnea (OSA) syndrome involves the use of Continuous, or Automatic Positive Airway Pressure (CPAP, APAP) machines, which work by delivering air via tubing and mask to a patient at pressures of up to 20cmH2O. This increased pressure is meant to stabilize the airway to reduce obstruction events. APAP machines are generally more effective and more comfortable for patients than CPAP machines because these devices automatically adjust pressure to treat an apnea. However, this treatment is reactive and often ineffective since the necessary pressure is applied seconds after breathing has already stopped; The results of a previous study performed showed strong indications for predicting an apnea before it occurs using measurements collected by existing sensors of the CPAP and APAP machines. If apnea events can be predicted before they occur, the air pressure required to treat them could be supplied ahead of time, preventing the apnea from occurring.
The hypothesis to be tested is whether obstructive sleep apnea events can be prevented, by predicting their onset ahead of time and adjusting the airway pressure accordingly.
Read the detailed description
Patients recruited for the study will undergo two different PAP therapy treatments during sleep: a control treatment and an intervention treatment. Both types of treatment will be delivered using a positive airway pressure (PAP) device with an Investigational Testing Authorization (ITA) from Health Canada (HC). This medical device consists of a commercially available PAP device which has been integrated with a feature to communicate with a computer hosting the predictive software via USB. Using signals received from the PAP device, the software can predict incoming apneas and direct the PAP machine to increase pressure for a short period of time; This study has been designed as a single-blind, randomised crossover study, in which recruited patients who suffer from Obstructive Sleep Apnea (OSA) will undergo at least two sleep studies. During a sleep study, the patient will spend a night of sleep at the sleep clinic (Sleep Disorders Clinic, QEII Abbie J. Lane Memorial Building) and receive one of two PAP therapy treatments; For the control treatment, the PAP device will deliver standard PAP therapy treatment to the patient; For the intervention treatment, the PAP device will deliver the standard PAP therapy treatment in addition to intervention when an apnea is predicted; All recruited participants will undergo at least two study nights and receive both treatments at least once; For all study night, standard Polysomnography (PSG) measurements will also be acquired (breathing rate, brain waves, movement, blood rate, oxygen levels, etc.); Participants will not be told what therapies are being used for each night, and the device used will be concealed from their view; After each night, participants will be asked to fill out a Satisfaction/Adherence questionnaire.
- Being tested
- cMAP Flow V 2.0
- Keywords
- APAP, CPAP, Airway obstructions
- Medical subject headings
- Sleep Apnea Syndromes, Airway Obstruction
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
cMAP Flow V 2.0Device
Also called Proactive airway management
Breathing data collected by the device will be processed by a machine learning algorithm to predict obstructive apnea events. When obstructive apnea events are predicted, the algorithm triggers the CPAP device to respond to the apnea event ahead of its onset.
For the control treatment, the device will operate as its conventional treatment.
| Study group | Role | What they receive |
|---|---|---|
| Intervention-first | Experimental | Participants in this arm will receive the Intervention treatment on the first night, and the control treatment on the second night. Receives: Device: cMAP Flow V 2.0 |
| Control-first | Experimental | Participants in this arm will receive the Control treatment on the first night, and the Intervention treatment on the second night. Receives: Device: cMAP Flow V 2.0 |
What is being measured
The primary outcome is the main question the study is designed to answer.
Apnea-Hypopnea Index (AHI)
To be measured via Polysomnography (PSG) data, which are standard measures obtained in sleep studies. AHI is measured as the average number of Apnea and Hypopnea occurrences in an hour during sleep (units: events/hour).
Measured: 2 nights (approx. 8hrs/night)
Obstructive Apnea Index
To be measured via Polysomnography (PSG) data, which are standard measures obtained in sleep studies. OAI is measured as the average number of exclusively Obstructive Apnea occurrences in an hour during sleep (units: events/hour).
Measured: 2 nights (approx. 8hrs/night)
Respiratory Disturbance Index
To be measured via Polysomnography (PSG) data, which are standard measures obtained in sleep studies.
RDI is measured as the average number of Apneas, Hypopneas and RERAs (Respiratory Effort Related Arousal) occurrences in an hour during sleep.
Measured: 2 nights (approx. 8hrs/night)
Secondary outcomes (2)
Oxygen Desaturation Index (ODI)
The ODI metric is also obtained through Polysomnography (PSG) data. ODI is measured as the average number of times per hour of sleep that the blood's oxygen level drop by a certain degree from baseline (units: events/hour).
Measured: 2 nights (approx. 8hrs/night)
Intervention treatment has an effect on patient adherence
Another objective will be the comparison of patient satisfaction after each night of sleep, which will be scored and quantified by an adherence/satisfaction questionnaire to determine whether the use of our device had a positive, or neutral effect on their sleep.
The questionnaire will be given to participants to fill out after treatment.
Questionnaire responses will be scaled to an Adherence score using a 11-point Likert rating scale. Higher scores indicate higher participant's adherence/satisfaction to the treatment.
Measured: 2 nights (approx. 8hrs/night)
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted5 May 2021
- Study start1 Dec 2021
- Primary completion12 Aug 2022
- Study completion12 Aug 2022
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Sleep Apnea, Mixed Central and ObstructiveStudies of the same condition, open and under way.
- 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
- Treatment
- Allocation
- Randomised
- Intervention model
- Crossover
- Model description
- This study has been designed as a single-blind, randomised crossover study, in which recruited patients who suffer from Obstructive Sleep Apnea (OSA) will undergo at least two sleep studies and receive two treatments. The intervention arm will be stratified into two groups based on their Obstructive Apnea Index (OAI): Group 1 (n=11): Low OAI, 0.8 \< OAI \< 2.99 and AHI \< 5.0 Group 2 (n=11): High OAI, OAI \> 3.0, and AHI \> 5.0
- Masking
- Single blind
- Who is masked
- Participant
- Enrolment
- 15 participants (actual)
Sponsor and investigators
- Lead sponsor
- NovaResp Technologies Inc
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
- Investigators
- Debra Morrison, M.D., Principal investigator, Nova Scotia Health
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04873024
- Sponsor's protocol ID
- Interventional-study
- Status last verified
- Apr 2024
- First submitted
- 12 Apr 2021
- Last updated
- 19 Apr 2024
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 19 Apr 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Real-time Prediction and Prevention of Apnea Events on PAP Machines in an Interventional Study
- ClinicalTrials.gov ID
- NCT04873024
- Acronym / sponsor ID
- Interventional-study
- Keywords
- APAP, CPAP, Airway obstructions
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 15 participants (actual)
- Lead sponsor
- NovaResp Technologies IncIndustry (pharma, biotech, devices)
- Study start
- 1 Dec 2021 (actual)
- Primary completion
- 12 Aug 2022 (actual)
- Study completion
- 12 Aug 2022 (actual)
- First posted
- 5 May 2021 (actual)
- 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.
The standard for treatment for people suffering from obstructive sleep apnea (OSA) syndrome involves the use of Continuous, or Automatic Positive Airway Pressure (CPAP, APAP) machines, which work by delivering air via tubing and mask to a patient at pressures of up to 20cmH2O. This increased pressure is meant to stabilize the airway to reduce obstruction events. APAP machines are generally more effective and more comfortable for patients than CPAP machines because these devices automatically adjust pressure to treat an apnea. However, this treatment is reactive and often ineffective since the necessary pressure is applied seconds after breathing has already stopped; The results of a previous study performed showed strong indications for predicting an apnea before it occurs using measurements collected by existing sensors of the CPAP and APAP machines. If apnea events can be predicted before they occur, the air pressure required to treat them could be supplied ahead of time, preventing the apnea from occurring.
The hypothesis to be tested is whether obstructive sleep apnea events can be prevented, by predicting their onset ahead of time and adjusting the airway pressure accordingly.
Detailed description
Patients recruited for the study will undergo two different PAP therapy treatments during sleep: a control treatment and an intervention treatment. Both types of treatment will be delivered using a positive airway pressure (PAP) device with an Investigational Testing Authorization (ITA) from Health Canada (HC). This medical device consists of a commercially available PAP device which has been integrated with a feature to communicate with a computer hosting the predictive software via USB. Using signals received from the PAP device, the software can predict incoming apneas and direct the PAP machine to increase pressure for a short period of time; This study has been designed as a single-blind, randomised crossover study, in which recruited patients who suffer from Obstructive Sleep Apnea (OSA) will undergo at least two sleep studies. During a sleep study, the patient will spend a night of sleep at the sleep clinic (Sleep Disorders Clinic, QEII Abbie J. Lane Memorial Building) and receive one of two PAP therapy treatments; For the control treatment, the PAP device will deliver standard PAP therapy treatment to the patient; For the intervention treatment, the PAP device will deliver the standard PAP therapy treatment in addition to intervention when an apnea is predicted; All recruited participants will undergo at least two study nights and receive both treatments at least once; For all study night, standard Polysomnography (PSG) measurements will also be acquired (breathing rate, brain waves, movement, blood rate, oxygen levels, etc.); Participants will not be told what therapies are being used for each night, and the device used will be concealed from their view; After each night, participants will be asked to fill out a Satisfaction/Adherence questionnaire.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Crossover
- Masking
- Single blind (participant)
- Number of arms
- 2
- Model description
- This study has been designed as a single-blind, randomised crossover study, in which recruited patients who suffer from Obstructive Sleep Apnea (OSA) will undergo at least two sleep studies and receive two treatments. The intervention arm will be stratified into two groups based on their Obstructive Apnea Index (OAI): Group 1 (n=11): Low OAI, 0.8 < OAI < 2.99 and AHI < 5.0 Group 2 (n=11): High OAI, OAI > 3.0, and AHI > 5.0
| Arm | Type | Receives |
|---|---|---|
| Intervention-first | Experimental | Device: cMAP Flow V 2.0Participants in this arm will receive the Intervention treatment on the first night, and the control treatment on the second night. |
| Control-first | Experimental | Device: cMAP Flow V 2.0Participants in this arm will receive the Control treatment on the first night, and the Intervention treatment on the second night. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (10 listed)
- No history of self-reported cardiovascular or neurological issues
- Must be a current PAP machine user.
- Must have used PAP machines for more than 4 months.
- Must be at least 18 years old
- Must be able to comply with all study requirements as outlined in the consent form
Key exclusion criteria (9 listed)
- Subjects actively using bi-level PAP or require oxygen therapy
- History of severe cardiovascular disease, including NYHA Class III or IV heart failure, CAD with angina, or MI/stroke within past 6 months
- Subjects who are medically complicated or who are medically unstable (i.e. cancer, dementia, unstable cardiac or respiratory disease, or unstable psychiatric illness)
- Potential sleep apnea complications that in the opinion of the clinician may affect the health and safety of the participant
- Subjects exhibiting any flu-like or any upper airway tract infection symptoms at the time of assessment
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 |
|---|---|---|
| cMAP Flow V 2.0Also: Proactive airway managementBreathing data collected by the device will be processed by a machine learning algorithm to predict obstructive apnea events. When obstructive apnea events are predicted, the algorithm triggers the CPAP device to respond to the apnea event ahead of its onset. For the control treatment, the device will operate as its conventional treatment. | Device | Control-first, Intervention-first |
Primary outcome
Apnea-Hypopnea Index (AHI)
Time frame: 2 nights (approx. 8hrs/night)
To be measured via Polysomnography (PSG) data, which are standard measures obtained in sleep studies. AHI is measured as the average number of Apnea and Hypopnea occurrences in an hour during sleep (units: events/hour).
Obstructive Apnea Index
Time frame: 2 nights (approx. 8hrs/night)
To be measured via Polysomnography (PSG) data, which are standard measures obtained in sleep studies. OAI is measured as the average number of exclusively Obstructive Apnea occurrences in an hour during sleep (units: events/hour).
Respiratory Disturbance Index
Time frame: 2 nights (approx. 8hrs/night)
To be measured via Polysomnography (PSG) data, which are standard measures obtained in sleep studies. RDI is measured as the average number of Apneas, Hypopneas and RERAs (Respiratory Effort Related Arousal) occurrences in an hour during sleep.
2 secondary outcomes
Oxygen Desaturation Index (ODI)
Time frame: 2 nights (approx. 8hrs/night)
Intervention treatment has an effect on patient adherence
Time frame: 2 nights (approx. 8hrs/night)
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 19 Apr 2024.
- Individual participant dataSharing planned: No
Related trials for Sleep Apnea, Mixed Central and Obstructive
Not yet recruitingObservational study
Natural History of Central and Mixed Sleep Apneas Followed by Maxillomandibular Advancement for Obstructive Sleep Apnea
Sleep Apnea Syndrome (OSAS), Central Sleep Apnea
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.
Debra Morrison, M.D. principal investigator
Nova Scotia 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 cMAP Flow V 2.0 in people with Sleep Apnea, Mixed Central and Obstructive, run by NovaResp Technologies Inc at 1 site in Canada.
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 10 inclusion and 9 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: finished, as of the sponsor's last update on 19 Apr 2024. 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 Canada. 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 is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
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?
Apnea-Hypopnea Index (AHI) (time frame: 2 nights (approx. 8hrs/night)). The study lists 3 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 19 Apr 2024.