Airway Muscle Activation on Sleep-disordered Breathing Events

NCT06002061 | Recruiting

• 1 other identifier: Muscle Activation
• Study Type: interventional
• Target: 10
• Locations: 1 country
• Sites: 1

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

Outcome Measures

Primary Outcomes (2)

• 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.

  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

  8 hours

Study Arms (1)

Muscle Activation

EXPERIMENTAL

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

Device: NovaResp MAPR System

Interventions

NovaResp MAPR System DEVICE

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.

Muscle Activation

Eligibility Criteria

• Age: 18 Years - 70 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• No history of self-reported, uncontrolled, severe cardiovascular or neurological issues
• Must be diagnosed with OSA

You may not qualify if:

• 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
• 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

Sponsors & Collaborators

• NovaResp Technologies Inc: lead

Study Sites (1)

Sleep Disorders Clinic

Halifax, Nova Scotia, B3H 2E2, Canada

RECRUITING

MeSH Terms

Conditions

Sleep Apnea Syndromes

Condition Hierarchy (Ancestors)

Apnea; Respiration Disorders; Respiratory Tract Diseases; Sleep Disorders, Intrinsic; Dyssomnias; Sleep Wake Disorders; Nervous System Diseases

Central Study Contacts

Hamed Hanafi, PhD

CONTACT

(902) 403-2443; hanafi@novaresp.com

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NA
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Model Details: 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.

Study Record Dates

• First Submitted: August 1, 2023
• First Posted: August 21, 2023
• Study Start: November 24, 2023
• Primary Completion: July 1, 2024
• Study Completion: July 1, 2024
• Last Updated: March 22, 2024

Record last verified: 2024-03

Data Sharing

• IPD Sharing: Will not share

Locations

CA (1)