Status:
UNKNOWN
Nocturnal Oxygen Needs and Central Sleep Apnea in Patients With Chronic Heart Failure.
Lead Sponsor:
Laval University
Collaborating Sponsors:
Oxynov
Philips Respironics
Conditions:
Chronic Heart Failure
Central Sleep Apnea
Eligibility:
All Genders
21+ years
Phase:
PHASE4
Brief Summary
The aims of this study are to 1) determine the optimal levels of O2 flow which prevent nocturnal O2 desaturation while minimizing periods of hyperoxia during the course of nocturnal oxygen therapy (NO...
Detailed Description
Sleep-related breathing disorders (obstructive and central) are highly prevalent in Heart failure (HF) patients and are associated with an increase in morbidity and mortality. Nocturnal oxygen therapy...
Eligibility Criteria
Inclusion
- patients with heart failure and reduced ejection fraction (LVEF \< 45%) due to ischemic or hypertensive heart disease
- moderate to severe central sleep apnea/cheyne stokes respiration.
- treatment should be stable for the last 30 days preceding entry into the study.
Exclusion
- O2 /CPAP therapy,
- active smoking,
- primary valvular heart disease,
- nasal obstruction,
- BMI ≥ 32 Kg/m2,
- cardiac surgery/transient ischemic attack/stroke/resynchronization therapy within 3 months,
- nocturnal hypoventilation,
- receiving opiates or methadone medication.
Key Trial Info
Start Date :
April 15 2018
Trial Type :
INTERVENTIONAL
Allocation :
ESTIMATED
End Date :
December 31 2022
Estimated Enrollment :
14 Patients enrolled
Trial Details
Trial ID
NCT03254212
Start Date
April 15 2018
End Date
December 31 2022
Last Update
April 8 2022
Active Locations (2)
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1
Frédéric Sériès
Québec, Qiebec, Canada, G1V 4G5
2
John Kimoff
Montreal, Quebec, Canada, H4A 3J1