Recruiting

Observational Study

Sponsor:

NovaResp Technologies Inc

Code:

NCT06002061

Conditions

Sleep Apnea

Eligibility Criteria

Sex: All

Age: 18 - 70

Healthy Volunteers: Not accepted

Interventions

NovaResp MAPR System

Study Details

Brief 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. 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.

Conditions

Sleep Apnea

Study ID

NCT06002061

Start date

Nov 24, 2023

Status verified date

Mar, 2024

Completion date

Jul, 2024

Anticipated

Primary completion date

Jul, 2024

Anticipated

Eligibility Criteria

Eligibility Criteria

Sex: All

Age: 18 - 70

Healthy Volunteers: Not accepted

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 Design

Enrollment

10 participants

Anticipated

Intervention Model

Single group

Primary purpose

Treatment

Interventions and Outcome Measures

Arms

experimental: Muscle Activation

Participants in this arm will receive intervention via application of brief air pressure maneuvers.

Interventions

NovaResp MAPR System

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.

Primary outcome measure

  • Evaluating level of activation through EMG [ Time Frame: 8 hours ]
  • Evaluating decrease in AHI [ Time Frame: 8 hours ]

Central Contacts and Locations

Central contacts

Locations

Sleep Disorders Clinic

Recruiting

Halifax, Nova Scotia, Canada, B3H 2E2

More Information

Sponsor

NovaResp Technologies Inc

Last update posted

Mar 22, 2024

Last verified

Mar, 2024

Trial information was received from ClinicalTrials.gov and was last updated on 2026-09-10. This information was provided to ClinicalTrials.gov by NovaResp Technologies Inc on 2024-03-22.