Status:
RECRUITING
Airway Muscle Activation on Sleep-disordered Breathing Events
Lead Sponsor:
NovaResp Technologies Inc
Conditions:
Sleep Apnea
Eligibility:
All Genders
18-70 years
Phase:
NA
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 d...
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 del...
Eligibility Criteria
Inclusion
- 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
- 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
Key Trial Info
Start Date :
November 24 2023
Trial Type :
INTERVENTIONAL
Allocation :
ESTIMATED
End Date :
July 1 2024
Estimated Enrollment :
10 Patients enrolled
Trial Details
Trial ID
NCT06002061
Start Date
November 24 2023
End Date
July 1 2024
Last Update
March 22 2024
Active Locations (1)
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1
Sleep Disorders Clinic
Halifax, Nova Scotia, Canada, B3H 2E2