Eligibility Module
The Eligibility Module contains detailed information about who can participate in the clinical trial. This includes eligibility criteria, age restrictions, gender requirements, healthy volunteer status, and study population descriptions, helping researchers understand who is eligible to participate in the study.
Eligibility Module path is as follows:
Study -> Protocol Section -> Eligibility Module
Eligibility Module
Ignite Creation Date:
2025-12-24 @ 4:43 PM
Ignite Modification Date:
2025-12-24 @ 4:43 PM
NCT ID:
NCT00756366
Eligibility Criteria:
Inclusion Criteria:
* systolic LV dysfunction (LVEF\<40%; by echocardiography, radionuclide or contrast ventriculography)
* symptoms of HF: NYHA Class II to III
* stable condition with optimally tolerated medical therapy, unchanged for \> 4 weeks
* Obstructive sleep apnea (OSA) diagnosed on nocturnal polysomnogram with an apnea/hypopnea index (AHI) \>15 events/hr and a predominantly obstructive pattern(more than 80% of events being obstructive in nature)OR
* no OSA: defined as AHI\<5 (control subjects) will be matched with the OSA group for gender, age + 5 years, ejection fraction (EF) +5%, drug therapy and etiology of HF (ischemic or non-ischemic)
* willingness to receive CPAP therapy
* informed consent
Exclusion Criteria:
* unstable angina or recent myocardial infarction (MI) (\<4 weeks prior)
* severe valvular dysfunction
* requirement for revascularization
* a permanent pacemaker
* atrial fibrillation
* significant ventricular arrhythmia or sinus node dysfunction
* life expectancy less than 1 year due to other co-morbidity
* significant restrictive and obstructive lung disease
* concomitant treatment or use of: tricyclic antidepressants, cocaine or drugs which may alter catecholamine uptake; or hypnotic, benzodiazepine, selective serotonin reuptake inhibitors(SSRI), neuroleptic, narcotic or other medications which may alter sleep or sleep-disordered breathing
* central sleep apnea
* other primary sleep disorder (i.e. periodic limb movement with arousal \>5 events/hr, narcolepsy, rapid eye movement (REM) behaviour disorder)
* requiring supplemental oxygen therapy at night
* debilitating daytime somnolence (indicating clear-cut indication for CPAP therapy)
* a previous cardiac transplant
* a large transmural scar defined on previous perfusion imaging(severe resting perfusion defect (\<50% uptake) occupying \>25% of the LV)148-150
* age \< 18 years
* pregnant or breast-feeding
Healthy Volunteers:
False
Sex:
ALL
Minimum Age:
18 Years
Study:
NCT00756366
Study Brief:
Protocol Section:
NCT00756366