Last updated: April 16, 2024
Sponsor: NovaResp Technologies Inc
Overall Status: Completed
Phase
N/A
Condition
Bronchiectasis
Sleep Apnea Syndromes
Treatment
cMAP Flow V 2.0
Clinical Study ID
NCT04873024
Interventional-study
Ages > 18 All Genders
Study Summary
Eligibility Criteria
Inclusion
Inclusion Criteria:
- 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 PAPdevice for inspection.
- Must be willing to have their CPAP SD memory card analyzed by OSCAR to determine theiraverage OAI over the past 30 days of use.
- For the low OAI group, participants must have an average OAI between 0.8 - 2.99 andAHI < 5.0 in the past 30 days, which would result in at least one obstructive apneaevery two hours each night.
- For the high OAI group, participants must have an average OAI ≥ 3.0 and AHI ≥ 5.0 inthe past 30 days, which would result in around 5 obstructive apneas every hour eachnight.
Exclusion
Exclusion Criteria:
- Subjects actively using bi-level PAP or require oxygen therapy
- History of severe cardiovascular disease, including NYHA Class III or IV heartfailure, 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 affectthe health and safety of the participant
- Subjects exhibiting any flu-like or any upper airway tract infection symptoms at thetime 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 allovernight testing done, AND who have an OAI < 3.0 and AHI < 5.0, will be excluded from thestudy, as this group has been fully enrolled to date.
Study Design
Total Participants: 15
Treatment Group(s): 1
Primary Treatment: cMAP Flow V 2.0
Phase:
Study Start date:
December 01, 2021
Estimated Completion Date:
August 12, 2022
Study Description
Connect with a study center
Sleep Disorders Clinic
Halifax, Nova Scotia B3H 2E2
CanadaSite Not Available
Not the study for you?
Let us help you find the best match. Sign up as a volunteer and receive email notifications when clinical trials are posted in the medical category of interest to you.