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Airway Muscle Activation on Sleep-disordered Breathing Events

Sleep Apnea

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.

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Participation Requirements

  • Sex:

    ALL

  • Eligible Ages:

    18 to 70

Participation Criteria

Inclusion Criteria:

* 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

Exclusion Criteria:

* 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.
* 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

Study Location

Sleep Disorders Clinic
Sleep Disorders Clinic
Halifax, Nova Scotia
Canada

Contact Study Team

Study Sponsored By
NovaResp Technologies Inc
Participants Required
More Information
Study ID: NCT06002061