Status:
COMPLETED
Prevention of Airway Obstruction Events
Lead Sponsor:
NovaResp Technologies Inc
Conditions:
Sleep Apnea, Mixed Central and Obstructive
Eligibility:
All Genders
18+ 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 two different PAP therapy treatments during sleep: a control treatment and an intervention treatment. Both types of treatment will be delivered using a po...
Eligibility Criteria
Inclusion
- No history of self-reported cardiovascular or neurological issues
- Must be a current PAP machine user.
- Must have used PAP machines for more than 4 months.
- Must be at least 18 years old
- 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
- For all nights of the study, participant must be willing to lend their personal PAP device for inspection.
- Must be willing to have their CPAP SD memory card analyzed by OSCAR to determine their average OAI over the past 30 days of use.
- For the low OAI group, participants must have an average OAI between 0.8 - 2.99 and AHI \< 5.0 in the past 30 days, which would result in at least one obstructive apnea every two hours each night.
- For the high OAI group, participants must have an average OAI ≥ 3.0 and AHI ≥ 5.0 in the past 30 days, which would result in around 5 obstructive apneas every hour each night.
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
- Subjects exhibiting any flu-like or any upper airway tract infection symptoms at the time of assessment
- Pregnant (confirmed verbally)
- Inability or unwillingness of individual to give written informed consent
- Has received bariatric surgery
- All participants currently screened, enrolled, and consented who have not yet had all overnight testing done, AND who have an OAI \< 3.0 and AHI \< 5.0, will be excluded from the study, as this group has been fully enrolled to date.
Key Trial Info
Start Date :
December 1 2021
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
August 12 2022
Estimated Enrollment :
15 Patients enrolled
Trial Details
Trial ID
NCT04873024
Start Date
December 1 2021
End Date
August 12 2022
Last Update
April 19 2024
Active Locations (1)
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1
Sleep Disorders Clinic
Halifax, Nova Scotia, Canada, B3H 2E2