Sleep ApneaNCT06002061
Airway Muscle Activation on Sleep-disordered Breathing Events
A study testing NovaResp MAPR System in people with Sleep Apnea, 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 to 70 years
- Conditions the study is for
- Sleep Apnea
- What is being tested?
- NovaResp MAPR System
- Type of treatment
- Medical device
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 10 participants
- Where
- 1 siteCanada
- Study dates
- 24 Nov 2023to Jul 2024
- 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 70 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- No history of self-reported, uncontrolled, severe cardiovascular or neurological issues
- Must be diagnosed with OSA
- Must be between 18 and 70 years old. People over 70 are excluded from this study, as they are more likely to have co-morbidities that overlap with the exclusion criteria for the study.
- 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
- Must be willing to lend their personal PAP device for inspection so that their personal PAP therapy settings can be transferred to one of our CPAP devices that has been modified to include the NovaResp MAPR System. Their device will not be used or modified during the study.
- Moderate or worse OSA (baseline AHI > 15 events/hour)
- BMI < 35 kg/m2
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
- Inability or unwillingness of individual to give written informed consent
- Neuromuscular disease, hypoglossal-nerve palsy, severe restrictive or obstructive pulmonary disease, moderate-to-severe pulmonary arterial hypertension, severe valvular heart disease, New York Heart Association class III or IV heart failure, recent myocardial infarction or severe cardiac arrhythmias (within the past 6 months), persistent uncontrolled hypertension despite medication use, active psychiatric disease, and coexisting non-respiratory sleep disorders that would confound functional sleep assessment.
Show all 9Show fewer
- A body-mass index (BMI; the weight in kilograms divided by the square of the height in meters) of more than 35.
- Pregnancy or planning attempting to become pregnant.
- Breastfeeding
Trial locations and contacts
1 site in 1 country.
Canada1 site, 1 recruiting
- Recruiting
Sleep Disorders Clinic
Halifax, Nova Scotia, B3H 2E2
About this study
Official title: Exploration of Potential Airway Muscle Activation on Sleep-Disordered Breathing Events Using Air Pressure Maneuvers
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. As a result of the high rate of patient dissatisfaction with conventional PAP therapy, alternative treatments for sleep apnea have been developed. One therapeutic target for OSA is stimulation of the genioglossus muscle, a phasic respiratory muscle important in maintaining upper airway patency.
Recently, it has been shown that genioglossus reflex responses can be achieved through the application of negative pressure pulses as well as changes in airway pressure. These studies focused on activating pressure-sensitive mechanoreceptors within the upper airway known to contribute to genioglossus activity. Together, these studies have demonstrated that both brief pulses of negative airway pressure and changes in airway pressure are capable of eliciting genioglossus reflex responses.
The goal of this interventional study is to evaluate the potential of airway muscle activation on sleep-disordered breathing during sleep therapy by applying brief maneuvers of air pressure using existing pressure and flow sensors in conventional CPAP machines.
Read the detailed description
Patients recruited for the study will undergo one overnight study period which will take place at the sleep clinic (Sleep Disorders Clinic, QEII Abbie J. Lane Memorial Building). 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 software via USB. The custom software has been developed to allow an operator to specify the pressure routine to be applied using a laptop computer, which then controls the CPAP and applies the routine.
The patient's personal PAP therapy settings will be transferred to this device so that the the only modified part of their therapy will be the brief pressure maneuvers. Standard PSG which typically consists of EEG, electrooculography, surface EMG, and electrocardiogram measurements as well as a submental needle EMG will be used to measure genioglossal activity. EMG needle insertion will be performed by an Otolaryngologist. Prior to insertion of the EMG needle, patients will be offered local anesthetic 1-2% lidocaine. Natus coated stainless steel wires (0.38 mm in diameter) will be inserted into the genioglossus muscle submentally using a 28-gauge TECA® Elite Disposable Monopolar Needle. Tegaderm tape will be used to adhere wires to the skin. Participants will be asked to perform tongue protrusions (pushing the tongue as hard and fast as possible against the top two incisor teeth) and several large swallows to confirm correct placement of the electrode and to measure maximal genioglossal activity. The brief air pressure maneuvers will be applied both before falling asleep and while asleep to compare muscle activation in awake and asleep conditions as described in the test plan below:
There are 3 stages to the test, described below.
Stage 1: Subject is awake. To begin, baseline measurements will be taken while the subject is awake. Genioglossus activity with maximal tongue protrusion will be measured as well as the response to 1 to 2 pressure routines.
Stage 2: Subject is asleep, manual control. Once the subject is sleeping, the operator will observe the PSG recording and determine sleep stage and respiratory phase (inspiration, expiration, between breaths). Each of the test routines will be performed for each sleep stage and each respiratory phase. If the operator notices an apnea occurring, one of the routines will be applied.
The shapes of the pressure routines are illustrated below, and the table corresponds to the test parameters for each test routine to be applied. If significant arousal is being caused as noted on the EEG, higher levels of pressure amplitudes of the routines may be aborted.
Stage 3: Subject is asleep, automatic control. When all manual tests are complete, an "automatic" mode will be engaged for the remainder of the night. During this mode, a previously developed and trialled AI model will be used to predict if an obstructive apnea is upcoming. The operator will input which routine to test, and the routine will be automatically applied when a prediction occurs. There will be a minimum of 60 seconds between pressure routine applications.
- Conditions
- Sleep Apnea
- Being tested
- NovaResp MAPR System
- 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.
NovaResp MAPR SystemDevice
Baseline measurements will be taken while the subject is awake. Genioglossus activity with maximal tongue protrusion will be measured as well as the response to 1 to 2 pressure routines. Once the subject is sleeping, the operator will observe the PSG recording and determine sleep stage and respiratory phase (inspiration, expiration, between breaths). Test routines will be performed for each sleep stage and each respiratory phase. If the operator notices an apnea occurring, one of the routines will be applied. When all manual tests are complete, an "automatic" mode will be engaged for the remainder of the night. During this mode, a previously developed and trialled AI model will be used to predict if an obstructive apnea is upcoming. The operator will input which routine to test, and the routine will be automatically applied when a prediction occurs. There will be a minimum of 60 seconds between pressure routine applications.
| Study group | Role | What they receive |
|---|---|---|
| Muscle Activation | Experimental | Participants in this arm will receive intervention via application of brief air pressure maneuvers. Receives: Device: NovaResp MAPR System |
What is being measured
The primary outcome is the main question the study is designed to answer.
Evaluating level of activation through EMG
Raw genioglossus EMG data collected from the submental needle EMG will be rectified and processed using a moving-time average window and expressed as a percentage (units: %) of maximal EMG, as determined by initial baseline measurements. The data will be assessed for muscle activity in the periods where pressure routines were applied and compared between different types of routines and periods without pressure routines. The percentage of maximal EMG will indicate to what level muscle activation has occurred. This value will display activation of the upper airway muscles in response to the brief air pressure maneuvers.
Measured: 8 hours
Evaluating decrease in AHI
The apnea-hypopnea index will be obtained through 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). A reduced AHI will display that the brief pressure maneuvers were successful in activating the upper airway muscle
Measured: 8 hours
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted21 Aug 2023
- Study start24 Nov 2023
- Primary completionJul 2024 (estimated)
- Study completionJul 2024 (estimated)
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.
- 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
- Not applicable
- Intervention model
- Single group
- Model description
- This study has been designed as a single group study, in which recruited patients who suffer from obstructive sleep apnea (OSA) will undergo one sleep study that will evaluate the effectiveness of applying brief air pressure maneuvers in activating the upper airway muscles.
- Masking
- None (open label)
- Enrolment
- 10 participants (estimated)
Sponsor and investigators
- Lead sponsor
- NovaResp Technologies Inc
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06002061
- Sponsor's protocol ID
- Muscle Activation
- Status last verified
- Mar 2024
- First submitted
- 1 Aug 2023
- Last updated
- 22 Mar 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 22 Mar 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Exploration of Potential Airway Muscle Activation on Sleep-Disordered Breathing Events Using Air Pressure Maneuvers
- ClinicalTrials.gov ID
- NCT06002061
- Acronym / sponsor ID
- Muscle Activation
- Conditions
- Sleep Apnea
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 10 participants (estimated)
- Lead sponsor
- NovaResp Technologies IncIndustry (pharma, biotech, devices)
- Study start
- 24 Nov 2023 (actual)
- Primary completion
- Jul 2024 (estimated)
- Study completion
- Jul 2024 (estimated)
- First posted
- 21 Aug 2023 (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. As a result of the high rate of patient dissatisfaction with conventional PAP therapy, alternative treatments for sleep apnea have been developed. One therapeutic target for OSA is stimulation of the genioglossus muscle, a phasic respiratory muscle important in maintaining upper airway patency.
Recently, it has been shown that genioglossus reflex responses can be achieved through the application of negative pressure pulses as well as changes in airway pressure. These studies focused on activating pressure-sensitive mechanoreceptors within the upper airway known to contribute to genioglossus activity. Together, these studies have demonstrated that both brief pulses of negative airway pressure and changes in airway pressure are capable of eliciting genioglossus reflex responses.
The goal of this interventional study is to evaluate the potential of airway muscle activation on sleep-disordered breathing during sleep therapy by applying brief maneuvers of air pressure using existing pressure and flow sensors in conventional CPAP machines.
Detailed description
Patients recruited for the study will undergo one overnight study period which will take place at the sleep clinic (Sleep Disorders Clinic, QEII Abbie J. Lane Memorial Building). 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 software via USB. The custom software has been developed to allow an operator to specify the pressure routine to be applied using a laptop computer, which then controls the CPAP and applies the routine.
The patient's personal PAP therapy settings will be transferred to this device so that the the only modified part of their therapy will be the brief pressure maneuvers. Standard PSG which typically consists of EEG, electrooculography, surface EMG, and electrocardiogram measurements as well as a submental needle EMG will be used to measure genioglossal activity. EMG needle insertion will be performed by an Otolaryngologist. Prior to insertion of the EMG needle, patients will be offered local anesthetic 1-2% lidocaine. Natus coated stainless steel wires (0.38 mm in diameter) will be inserted into the genioglossus muscle submentally using a 28-gauge TECA® Elite Disposable Monopolar Needle. Tegaderm tape will be used to adhere wires to the skin. Participants will be asked to perform tongue protrusions (pushing the tongue as hard and fast as possible against the top two incisor teeth) and several large swallows to confirm correct placement of the electrode and to measure maximal genioglossal activity. The brief air pressure maneuvers will be applied both before falling asleep and while asleep to compare muscle activation in awake and asleep conditions as described in the test plan below:
There are 3 stages to the test, described below.
Stage 1: Subject is awake. To begin, baseline measurements will be taken while the subject is awake. Genioglossus activity with maximal tongue protrusion will be measured as well as the response to 1 to 2 pressure routines.
Stage 2: Subject is asleep, manual control. Once the subject is sleeping, the operator will observe the PSG recording and determine sleep stage and respiratory phase (inspiration, expiration, between breaths). Each of the test routines will be performed for each sleep stage and each respiratory phase. If the operator notices an apnea occurring, one of the routines will be applied.
The shapes of the pressure routines are illustrated below, and the table corresponds to the test parameters for each test routine to be applied. If significant arousal is being caused as noted on the EEG, higher levels of pressure amplitudes of the routines may be aborted.
Stage 3: Subject is asleep, automatic control. When all manual tests are complete, an "automatic" mode will be engaged for the remainder of the night. During this mode, a previously developed and trialled AI model will be used to predict if an obstructive apnea is upcoming. The operator will input which routine to test, and the routine will be automatically applied when a prediction occurs. There will be a minimum of 60 seconds between pressure routine applications.
Study design
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
- Model description
- This study has been designed as a single group study, in which recruited patients who suffer from obstructive sleep apnea (OSA) will undergo one sleep study that will evaluate the effectiveness of applying brief air pressure maneuvers in activating the upper airway muscles.
| Arm | Type | Receives |
|---|---|---|
| Muscle Activation | Experimental | Device: NovaResp MAPR SystemParticipants in this arm will receive intervention via application of brief air pressure maneuvers. |
Who may qualify
- Ages
- 18 to 70 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (8 listed)
- No history of self-reported, uncontrolled, severe cardiovascular or neurological issues
- Must be diagnosed with OSA
- Must be between 18 and 70 years old. People over 70 are excluded from this study, as they are more likely to have co-morbidities that overlap with the exclusion criteria for the study.
- 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
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
- Inability or unwillingness of individual to give written informed consent
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 |
|---|---|---|
| NovaResp MAPR SystemBaseline measurements will be taken while the subject is awake. Genioglossus activity with maximal tongue protrusion will be measured as well as the response to 1 to 2 pressure routines. Once the subject is sleeping, the operator will observe the PSG recording and determine sleep stage and respiratory phase (inspiration, expiration, between breaths). Test routines will be performed for each sleep stage and each respiratory phase. If the operator notices an apnea occurring, one of the routines will be applied. When all manual tests are complete, an "automatic" mode will be engaged for the remainder of the night. During this mode, a previously developed and trialled AI model will be used to predict if an obstructive apnea is upcoming. The operator will input which routine to test, and the routine will be automatically applied when a prediction occurs. There will be a minimum of 60 seconds between pressure routine applications. | Device | Muscle Activation |
Primary outcome
Evaluating level of activation through EMG
Time frame: 8 hours
Raw genioglossus EMG data collected from the submental needle EMG will be rectified and processed using a moving-time average window and expressed as a percentage (units: %) of maximal EMG, as determined by initial baseline measurements. The data will be assessed for muscle activity in the periods where pressure routines were applied and compared between different types of routines and periods without pressure routines. The percentage of maximal EMG will indicate to what level muscle activation has occurred. This value will display activation of the upper airway muscles in response to the brief air pressure maneuvers.
Evaluating decrease in AHI
Time frame: 8 hours
The apnea-hypopnea index will be obtained through 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). A reduced AHI will display that the brief pressure maneuvers were successful in activating the upper airway muscle
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 22 Mar 2024.
- Individual participant dataSharing planned: No
Related trials for Sleep Apnea
RecruitingObservational study
Locus Coeruleus and CCHS (Congenital Central Hypoventilation Syndrome)
Ondine Syndrome (Congenital Central Hypoventilation Syndrome)
RecruitingObservational study
Development and Validation of a Multimodal Deep Learning Model Using Peripheral Oxygen Saturation and Ballistocardiography Signals for Predicting Apnea-Hypopnea Index in Obstructive Sleep Apnea
Obstructive Sleep Apnea
Not yet recruiting
Comprehensive Opioid Management and Breathing During Sleep
Sleep-Disordered Breathing, Chronic Opioid Use
Recruiting
Janus II Feasibility
Sleep Apnea
RecruitingPhase 3
A Study to Learn About the Monthly Dosing Study Medicine Called Berobenatide in Adults With Breathing Problems During Sleep and Overweight or Obesity Who Do Not Use a Breathing Machine (PAP) (VESPER-OSA 2)
Apnea, Sleep Disorders
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.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing NovaResp MAPR System in people with Sleep Apnea, 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 8 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: status not confirmed, as of the sponsor's last update on 22 Mar 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?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact Hamed Hanafi, PhD ((902) 403-2443, hanafi@novaresp.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Evaluating level of activation through EMG (time frame: 8 hours). The study lists 2 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 22 Mar 2024.