Sleep Medicine Clinical Trials

Inclusion Criteria:

• Aged ≥ 21 years at the date of consent.
• History of chronic, stable heart failure with reduced ejection fraction with left ventricular ejection fraction (LVEF) ≤ 45% determined by echocardiography, radionuclide angiography, left ventriculography, or cardiac magnetic resonance imaging, within the year prior to enrollment.
• Central sleep apnea, defined using as an apnea-hypopnea index (AHI) > 15/h with ≥ 50% central events (apnea and hypopneas) and a central AHI ≥ 10/h or obstructive apnea index (OAI) < 20%
• New York Heart Association (NYHA) Class III or IV, or NYHA Class II with ≥ 1 hospitalization for HF in the last 24 months.
• Treatment with stable, optimized guideline-directed medical therapies (GDMT) according to applicable guidelines in the U.S. and Canada, where stable is defined as the addition of no new class of disease-modifying drug for ≥ 30 days prior to randomization.
• In the investigator's opinion, willing and able to comply with all study requirements
• Able to fully understand study information and sign an Institutional Review Board (IRB) approved informed consent

Exclusion Criteria:

• Current positive airway pressure use of diagnosis of Obstructive Sleep Apnea (OSA).
• Oxygen saturation < 90% at rest during the day.
• Oxygen saturation < 88% for > 5 continuous minutes during sleep unaccompanied by respiratory events.
• Chronic daytime or nighttime use of supplemental oxygen.
• Current smoker or bed partner that smokes in the bedroom.
• Severe pulmonary disease requiring continuous home oxygen therapy or the continuous or frequent intermittent use of oral steroids or documented severe chronic obstructive pulmonary disease (COPD) with forced expiratory volume in 1 second (FEV1) < 50%.
• Body mass index (BMI) > 35 kg/m2.
• Cardiac surgery, percutaneous coronary intervention, myocardial infarction or unstable angina within the previous 3 months.
• Transient ischemic attack or stroke within the previous 3 months.
• Cardiac resynchronization therapy implantation scheduled or performed within 3 months prior to randomization.
• Primary hemodynamically-significant uncorrected valvular heart disease (obstructive or regurgitant) or any valvular disease expected to require surgery during the trial
• Acute myocarditis/pericarditis or other cause of potentially reversible cardiomyopathy (e.g., post-partum cardiomyopathy, tachycardia-induced cardiomyopathy), within the previous 6 months.
• End-stage (Stage D) heart failure (HF) requiring continuous outpatient intravenous (IV) inotropic therapy, placement of ventricular assist device, listing for cardiac transplantation, or end-of-life care (e.g. hospice care).
• Pregnancy or of child bearing potential without a negative pregnancy test within 10 days prior to enrollment.
• Life expectancy < 1 year for diseases unrelated to chronic HF.
• Enrolled or planning to enroll in another study that may conflict with protocol requirements or confound subject results in this trial.

• Inclusion Criteria:

  • Ability and acceptance to provide written informed consent of the participant or legal guardian. Participants ≥ 16 and < 18 years of age will also need to provide written assent.
  • A confirmed clinical diagnosis of Delayed Sleep-Wake Phase Disorder (DSWPD).
  • Men or women between 16 - 65 years, inclusive.
  • Body Mass Index (BMI) of ≥ 18 and ≤ 30 kg/m^2.

• Exclusion Criteria:
• History of psychiatric disorders within 12 months.
• Major surgery, trauma, illness, general anesthesia, or immobility for 3 or more days within the last 30 days.
• Pregnancy, recent pregnancy (within 6 weeks), or women who are breastfeeding.
• A positive test for substances of abuse