# Impact of Low Flow Nocturnal Oxygen Therapy On Hospital Readmission/Mortalityin Patients with Heart Failure and Central Sleep Apneal (LOFT-HF)

> **NIH NIH UH3** · OHIO STATE UNIVERSITY · 2020 · $2,331,948

## Abstract

Central sleep apnea (CSA), prevalent in approximately 40% of patients with heart failure with reduced ejection
fraction (HFrEF), predicts high rates of morbidity, hospitalizations, and mortality. Adverse effects are thought to
be attributable to hypoxemia, central nervous system arousal, and sympathetic nervous system activation
resulting from episodic breathing disturbances and oxyhemoglobin desaturation. Until recently, the
recommended treatment for CSA with HFrEF was adaptive servo-ventilation (ASV). A recent multi-national
trial, however, identified an adverse effect of ASV on mortality, leaving a void in therapeutic options for patients
with these co-morbid disorders. Although low flow nocturnal oxygen, which provides a physiologically sound
intervention for blunting hypoxemia-associated physiological stresses and sympathetic activation, and
improves short-term intermediate outcomes in patients with CSA and HFrEF, no large scale study yet has
examined its long term impact on clinically important outcomes. We have assembled a team of leaders in
cardiology, sleep medicine and clinical trials to conduct a pragmatic trial designed to test the hypothesis that
nocturnal oxygen therapy (NOXT) in patients with CSA and HFrEF will reduce mortality and unplanned
hospitalizations for worsening HF. Secondary endpoints evaluate other measures of morbidity and mortality,
functional status, exercise capacity, quality of life, mood, and sleep quality. Using a double-blinded,
randomized design, we will screen 2,450 patients with home sleep studies, estimating that 35% (n=858) will
meet study eligibility criteria for CSA. Participants will be randomized to NOXT or sham-NOXT and undergo
standardized assessments including a 6 minute walk test, complete validated questionnaires, and will be
followed for study outcomes for as long as 4.5 years. Oxygen use and oxygen saturation levels will be centrally
monitored using cloud-based software. Primary outcomes will be assessed using a time to first event analysis,
and secondarily as recurrent event rates. Highly efficient methods for data capture and monitoring and project
management will be deployed. Novel physiological markers of ventilation during sleep will be derived to identify
responsive subgroups. This rigorous yet practical design will provide pivotal trial data needed to identify the
role of a potentially beneficial and acceptable therapy which has yet to be tested on a large scale in
a population with high morbidity and mortality, for a condition where there is no current evidence-based
treatment. The sleep assessments and interventions are practically designed with the objective of facilitating
their rapid uptake and use by the cardiology and sleep communities. This Data Coordinating Center application
is to provide the study comprehensive, responsive, and innovative data management and study coordination
services, biostatistical analysis, rigorous adjudication of study outcomes, and centralized sleep analy...

## Key facts

- **NIH application ID:** 10005449
- **Project number:** 5UH3HL140144-03
- **Recipient organization:** OHIO STATE UNIVERSITY
- **Principal Investigator:** WILLIAM Tober ABRAHAM
- **Activity code:** UH3 (R01, R21, SBIR, etc.)
- **Funding institute:** NIH
- **Fiscal year:** 2020
- **Award amount:** $2,331,948
- **Award type:** 5
- **Project period:** 2018-09-01 → 2022-08-31

## Primary source

NIH RePORTER: https://reporter.nih.gov/project-details/10005449

## Citation

> US National Institutes of Health, RePORTER application 10005449, Impact of Low Flow Nocturnal Oxygen Therapy On Hospital Readmission/Mortalityin Patients with Heart Failure and Central Sleep Apneal (LOFT-HF) (5UH3HL140144-03). Retrieved via AI Analytics 2026-05-23 from https://api.ai-analytics.org/grant/nih/10005449. Licensed CC0.

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