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The Impact of Low Flow Nocturnal Oxygen Therapy on Hospital Admissions and Mortality in Patients With Heart Failure and Central Sleep Apnea

NCT03745898 · Status: TERMINATED · Phase: PHASE3 · Type: INTERVENTIONAL · Enrollment: 98

Last updated 2023-08-01

Study results available
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Summary

The purpose of this trial is to evaluate the long-term effects of Nocturnal Oxygen Therapy (NOXT) on the mortality and morbidity of patients with stable heart failure and a reduced ejection fraction (HFrEF), already receiving optimal guideline-directed medical therapy (GDMT), who have central sleep apnea (CSA).

Conditions

Interventions

DRUG

Oxygen

Active nocturnal oxygen concentrator

OTHER

Room Air

Sham nocturnal oxygen concentrator (room air)

Sponsors & Collaborators

  • Ohio State University

    collaborator OTHER

  • Brigham and Women's Hospital

    lead OTHER

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
TRIPLE
Model
PARALLEL

Eligibility

Min Age
21 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2019-04-15
Primary Completion
2022-06-17
Completion
2022-06-17
FDA Drug
Yes

Countries

  • United States

Study Locations

More Related Trials

Entities

Diseases

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT03745898 on ClinicalTrials.gov