Oxygen Versus PAP for Sleep Apnea in Heart Failure

NCT01807897 | Completed Phase 4 Results DMC FDA Device

• 1 other identifier: CLIN-008-12S
• Study Type: interventional
• Target: 74
• Locations: 1 country
• Sites: 2

Brief 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.

Conditions

Heart Failure; Sleep Apnea Syndromes

Keywords

Heart Failure; Sleep Apnea; Ventricular Ejection Fraction; Exercise Test

Outcome Measures

Primary Outcomes (1)

• Left Ventricular Ejection Fraction

  Standard transthoracic 2-dimensional and Doppler echocardiography will be performed. M-mode measurements of LV dimensions will be performed and analyzed according to the American Society of Echocardiography recommendations and LVEF measured using the modified Simpson's method. Measurement is change from baseline in LVEF.

  3 months

Secondary Outcomes (2)

• Peak Oxygen Consumption (VO2 Peak)

  3 months

• 24-hour Ambulatory Blood Pressure

  3 months

Study Arms (3)

CPAP

EXPERIMENTAL

Nocturnal continuous positive airway pressure

Device: Continuous positive airway pressure; Behavioral: Healthy Lifestyle and Sleep Education

NSO

EXPERIMENTAL

Nocturnal supplemental oxygen

Device: Nocturnal supplemental oxygen; Behavioral: Healthy Lifestyle and Sleep Education

HLSE

OTHER

Healthy lifestyle and sleep education control

Behavioral: Healthy Lifestyle and Sleep Education

Interventions

Continuous positive airway pressure DEVICE

Nocturnal continuous positive airway pressure, titrated to minimize apnea-hypopnea index

Also known as: CPAP

CPAP

Nocturnal supplemental oxygen DEVICE

Nocturnal supplemental oxygen, titrated to 2-4 liters/minute with target of eliminating nocturnal hypoxemia

Also known as: NSO

NSO

Healthy Lifestyle and Sleep Education BEHAVIORAL

A 60-minute educational intervention with slide show and printed materials, educating the patient in healthy sleep habits and heart-healthy lifestyle

Also known as: HLSE

CPAP; HLSE; NSO

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Veteran receiving care within the Veterans Health Administration healthcare system
• Age 18 years
• Physician diagnosis of chronic heart failure, American Heart Association Stage C-D
• LVEF \<45%
• No change in active cardiac medications for 4 weeks prior to randomization
• Ability to provide informed consent
• Moderate to severe central or mixed central and obstructive sleep apnea, defined as an apnea-hypopnea index (AHI) 15 events per hour, with a central AHI \>5 events/hour

You may not qualify if:

• Hospitalization for acute decompensated HF within previous 30 days
• Hospitalization for myocardial infarction or cardiac surgery within previous 90 days
• Presence of a left ventricular assist device
• History of heart transplantation
• Poorly controlled hypertension (\>170/\>110)
• Poorly controlled diabetes (HbA1c \> 9.0)
• Severe renal failure with estimated glomerular filtration rate \<30 ml/min
• Prior stroke with functional impairment or other severe, uncontrolled medical problems that may impair ability to participate in the study exams, based on medical history and review of medical records
• Severe chronic insomnia, with reported usual sleep duration \<4 hours
• Severe daytime sleepiness, defined as Epworth Sleepiness Scale score 18 or higher or a report of falling asleep driving during the previous year, and deemed a safety risk by study physician
• Awake resting oxyhemoglobin saturation \<89%
• Pregnancy
• Smoking by subject or other person in the subject's bedroom, or other open flame in bedroom
• Current use of a positive airway pressure device (including continuous or bi-level positive airway pressure or adaptive servo-ventilation) or supplemental oxygen therapy

Sponsors & Collaborators

• VA Office of Research and Development: lead

Study Sites (2)

VA Connecticut Healthcare System West Haven Campus, West Haven, CT

West Haven, Connecticut, 06516, United States

Location

VA Boston Healthcare System Jamaica Plain Campus, Jamaica Plain, MA

Boston, Massachusetts, 02130, United States

Location

MeSH Terms

Conditions

Heart Failure; Sleep Apnea Syndromes

Interventions

Continuous Positive Airway Pressure

Condition Hierarchy (Ancestors)

Heart Diseases; Cardiovascular Diseases; Apnea; Respiration Disorders; Respiratory Tract Diseases; Sleep Disorders, Intrinsic; Dyssomnias; Sleep Wake Disorders; Nervous System Diseases

Intervention Hierarchy (Ancestors)

Positive-Pressure Respiration; Respiration, Artificial; Airway Management; Therapeutics; Respiratory Therapy

Results Point of Contact

• Title: Dr. Daniel Gottlieb
• Organization: VA Boston Healthcare System

daniel.gottlieb@va.gov

857-203-6175

Study Officials

• Daniel J Gottlieb, MD MPH

  VA Boston Healthcare System Jamaica Plain Campus, Jamaica Plain, MA

  PRINCIPAL INVESTIGATOR

Publication Agreements

• PI is Sponsor Employee: Yes

Study Design

• Study Type: interventional
• Phase: phase 4
• Allocation: RANDOMIZED
• Masking: SINGLE
• Who Masked: OUTCOMES ASSESSOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: FED
• Responsible Party: SPONSOR

Model Details: Continuous positive airway pressure (CPAP) and supplemental oxygen

Study Record Dates

• First Submitted: March 1, 2013
• First Posted: March 8, 2013
• Study Start: June 23, 2014
• Primary Completion: June 30, 2020
• Study Completion: June 30, 2020
• Last Updated: January 25, 2023
• Results First Posted: January 25, 2023

Record last verified: 2022-12

Data Sharing

• IPD Sharing: Will not share

Locations

US (2)