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Positive Airway Pressure Device

HLSE for Sleep Apnea (OPTIMAL-HF Trial)

Phase 4
Waitlist Available
Led By Daniel J Gottlieb, MD MPH
Research Sponsored by VA Office of Research and Development
Eligibility Criteria Checklist
Specific guidelines that determine who can or cannot participate in a clinical trial
Must have
Be older than 18 years old
Timeline
Screening 3 weeks
Treatment Varies
Follow Up 3 months
Awards & highlights

Summary

The purpose of this study is to compare three treatment modalities for central, or mixed obstructive and central, sleep apnea in patients with chronic heart failure and reduced ejection fraction. The modalities to be tested are nocturnal supplemental oxygen (NSO) and continuous positive airway pressure (CPAP). The main outcome measures will be left ventricular ejection fraction on echocardiogram and peak oxygen consumption on cardiopulmonary exercise testing.

Eligible Conditions
  • Sleep Apnea
  • Heart Failure

Timeline

Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~3 months
This trial's timeline: 3 weeks for screening, Varies for treatment, and 3 months for reporting.

Treatment Details

Study Objectives

Outcome measures can provide a clearer picture of what you can expect from a treatment.
Primary outcome measures
Left Ventricular Ejection Fraction
Secondary outcome measures
24-hour Ambulatory Blood Pressure
Peak Oxygen Consumption (VO2 Peak)

Trial Design

3Treatment groups
Experimental Treatment
Group I: NSOExperimental Treatment2 Interventions
Nocturnal supplemental oxygen
Group II: HLSEExperimental Treatment1 Intervention
Healthy lifestyle and sleep education control
Group III: CPAPExperimental Treatment2 Interventions
Nocturnal continuous positive airway pressure
Treatment
First Studied
Drug Approval Stage
How many patients have taken this drug
Continuous positive airway pressure
2013
Completed Phase 4
~1630
Nocturnal supplemental oxygen
2014
Completed Phase 4
~80
Healthy Lifestyle and Sleep Education
2014
Completed Phase 4
~80

Find a Location

Who is running the clinical trial?

VA Office of Research and DevelopmentLead Sponsor
1,647 Previous Clinical Trials
3,359,996 Total Patients Enrolled
9 Trials studying Sleep Apnea
1,106 Patients Enrolled for Sleep Apnea
Daniel J Gottlieb, MD MPHPrincipal InvestigatorVA Boston Healthcare System Jamaica Plain Campus, Jamaica Plain, MA
1 Previous Clinical Trials
4 Total Patients Enrolled
~7 spots leftby Sep 2025
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