Trial · NCT03745898

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

NCT03745898, Phase 3, Terminated, Brigham and Women's Hospital; results first posted 2023-08-01

3 sourcestrials-2026-11-12-0.5.0

Cite this record

ConductScience Library. The Impact of Low Flow Nocturnal Oxygen Therapy on Hospital Admissions and Mortality in Patients With Heart Failure and Central Sleep Apnea. Trials, record NCT03745898. Release trials-2026-11-12-0.5.0, 12 Nov 2026. https://conductscience.org/library/trials/NCT03745898

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Trial

As registered on ClinicalTrials.gov, in the graph's capture of the registry.

Title: The Impact of Low Flow Nocturnal Oxygen Therapy on Hospital Admissions and Mortality in Patients With Heart Failure and Central Sleep Apnea
NCT number: NCT03745898
Status: Terminated
Phases: Phase 3
Enrollment: 98 participants, actual
Lead sponsor: Brigham and Women's Hospital
Conditions: Heart Failure, Central Sleep Apnea
Interventions: Oxygen, Room Air
First posted: 2018-11-19
Last updated: 2023-08-01
Results first posted: 2023-08-01
Limitations and caveats: Study incomplete due to early termination

Source ClinicalTrials.gov

Registered outcomes7

Each outcome the trial registered, primary first, in ClinicalTrials.gov's words.

List	Outcome	Time frame	Description
Primary	First Occurrence of Mortality Due to Any Cause or an Unplanned Hospitalization for Worsening Heart Failure or a Life-saving Cardiovascular (CV) Intervention	12 months	This is a composite primary outcome
Secondary	Recurrent Event Analyses of Mortality and Morbidity	From enrollment to study termination, attrition or death. Min = 41 days, Max = 626 Days	Count of occurrences of mortality due to any cause or an unplanned hospitalization for worsening heart failure or a Life-saving Cardiovascular (CV) Intervention. (Death, Hospitalization HF / Outpatient HF, Myocardial Infarction / Unstable Angina, Resuscitated Cardiac Arrest, Stroke)
Secondary	Quality of Life and Symptoms - HF Disease-specific Quality of Life	Baseline, 6 month follow up	HF disease-specific quality of life will be assessed by the change in the Kansas City Cardiomyopathy Questionnaire (KCCQ). The KCCQ quantifies physical function, symptoms (frequency, severity and recent change), social function, self-efficacy and knowledge, and quality of life for those who have heart failure. An overall summary score is derived from the physical function, symptom (frequency and severity), social function and quality of life domains. Scores are transformed to a range of 0-100, in which higher scores reflect better health status.
Secondary	Quality of Life and Symptoms - Generic-quality of Life	Baseline, 6 month follow up	Generic-quality of life will be assessed by the change in the Euroqol - 5 Dimensions (EQ-5D) questionnaire. The questionnaire comprises of 5 dimensions: mobility, self-care, usual activities, pain/discomfort and anxiety/depression. Each dimension has 3 levels: no problems, some problems, and extreme problems. A total score in calculated using a US-specific weighted algorithm with a possible range \[-0.109,1\], where 1 represents the best outcome with 'no problems' selected for every item on the scale.
Secondary	Quality of Life and Symptoms - Depressive Symptoms	Baseline, 6 month follow up	Depressive symptoms will be assessed by the change in the Patient Health Questionnaire - 8 items (PHQ-8). A scores ranges from 0 to 24. A score greater than 10 is considered major depression and a score 20 or more is considered severe major depression.
Secondary	Quality of Life and Symptoms - Sleep Symptoms and Sleep Related Daytime Impairment	Baseline, 6 month follow up	Sleep symptoms and sleep related daytime impairment will be assessed by the change in the Patient-Reported Outcomes Measurement Information System (PROMIS) Sleep Disturbance (SD) Questionnaire and Sleep Related Impairment (SRI) Questionnaire. The final score for each is represented by the T-score, a standardized score with a population mean of 50 and a standard deviation (SD) of 10, where a higher score indicates a worse score. For SRI a T-score \>= 60 implies high levels of sleep related impairment, and for PROMIS SD a T-score \>= 60 implies high levels of sleep disturbance.
Secondary	Functional Status	Baseline, 6 month follow up	Functional status will be assessed by the change in New York Heart Association (NYHA) Functional Class Ranking, where higher classes indicate decreased function (worse outcome). Possible Classes are I-IV, which indicate a score of 1-4. Class I indicates No limitation of physical activity. Ordinary physical activity does not cause undue fatigue, palpitation or shortness of breath. ; Class II indicates Slight limitation of physical activity. Comfortable at rest. Ordinary physical activity results in fatigue, palpitation, shortness of breath or chest pain. ; Class III indicates Marked limitation of physical activity. Comfortable at rest. Less than ordinary activity causes fatigue, palpitation, shortness of breath or chest pain. ; and Class IV indicates Symptoms of heart failure at rest. Any physical activity causes further discomfort.

Source ClinicalTrials.gov

Outcomes7

Each outcome the trial posted results for, in ClinicalTrials.gov's words.

Type	Outcome	Time frame	Population	Units	Measured as
PRIMARY	First Occurrence of Mortality Due to Any Cause or an Unplanned Hospitalization for Worsening Heart Failure or a Life-saving Cardiovascular (CV) Intervention	12 months	Recruitment incomplete due to early termination	Participants	COUNT_OF_PARTICIPANTS
SECONDARY	Recurrent Event Analyses of Mortality and Morbidity	From enrollment to study termination, attrition or death. Min = 41 days, Max = 626 Days	Incomplete due to early termination	events	NUMBER
SECONDARY	Quality of Life and Symptoms - HF Disease-specific Quality of Life	Baseline, 6 month follow up	Incomplete due to early termination	score on a scale	MEAN
SECONDARY	Quality of Life and Symptoms - Generic-quality of Life	Baseline, 6 month follow up	Incomplete due to early termination	score on a scale	MEAN
SECONDARY	Quality of Life and Symptoms - Depressive Symptoms	Baseline, 6 month follow up	Incomplete due to early termination	score on a scale	MEAN
SECONDARY	Quality of Life and Symptoms - Sleep Symptoms and Sleep Related Daytime Impairment	Baseline, 6 month follow up	Incomplete due to early termination	score on a scale	MEAN
SECONDARY	Functional Status	Baseline, 6 month follow up	Incomplete due to early termination	score on a scale	MEAN

Source ClinicalTrials.gov

Results by group16

Each measurement the trial posted, group by group, in the words and numbers it posted.

Outcome	Group	Value	Spread	Units
First Occurrence of Mortality Due to Any Cause or an Unplanned Hospitalization for Worsening Heart Failure or a Life-saving Cardiovascular (CV) Intervention	Nocturnal Oxygen Therapy	15		Participants
First Occurrence of Mortality Due to Any Cause or an Unplanned Hospitalization for Worsening Heart Failure or a Life-saving Cardiovascular (CV) Intervention	Sham Nocturnal Oxygen Therapy	9		Participants
Recurrent Event Analyses of Mortality and Morbidity	Nocturnal Oxygen Therapy	22		events
Recurrent Event Analyses of Mortality and Morbidity	Sham Nocturnal Oxygen Therapy	18		events
Quality of Life and Symptoms - HF Disease-specific Quality of Life	Nocturnal Oxygen Therapy	7.19	Standard Deviation 22.32	score on a scale
Quality of Life and Symptoms - HF Disease-specific Quality of Life	Sham Nocturnal Oxygen Therapy	4.83	Standard Deviation 13.43	score on a scale
Quality of Life and Symptoms - Generic-quality of Life	Nocturnal Oxygen Therapy	0.06	Standard Deviation 0.19	score on a scale
Quality of Life and Symptoms - Generic-quality of Life	Sham Nocturnal Oxygen Therapy	0.02	Standard Deviation 0.11	score on a scale
Quality of Life and Symptoms - Depressive Symptoms	Nocturnal Oxygen Therapy	-2.21	Standard Deviation 5.01	score on a scale
Quality of Life and Symptoms - Depressive Symptoms	Sham Nocturnal Oxygen Therapy	-1.61	Standard Deviation 5.85	score on a scale

1 to 10 of 16Source ClinicalTrials.gov

See all 16 results by group

Participant flow6

How many started, completed or left each group, period by period.

Period	Milestone	Group	Participants
Overall Study	STARTED	Nocturnal Oxygen Therapy	48
Overall Study	STARTED	Sham Nocturnal Oxygen Therapy	50
Overall Study	COMPLETED	Nocturnal Oxygen Therapy	48
Overall Study	COMPLETED	Sham Nocturnal Oxygen Therapy	50
Overall Study	NOT COMPLETED	Nocturnal Oxygen Therapy	0
Overall Study	NOT COMPLETED	Sham Nocturnal Oxygen Therapy	0

Source ClinicalTrials.gov

Adverse events144

Each adverse event the trial posted, group by group: the participants affected out of those at risk.

Type	Event	Organ system	Group	Affected	At risk	Events
other	2019 novel coronavirus infection	Infections and infestations	Nocturnal Oxygen Therapy	3	48	3
other	2019 novel coronavirus infection	Infections and infestations	Sham Nocturnal Oxygen Therapy	3	50	3
other	Congestive heart failure	Cardiac disorders	Nocturnal Oxygen Therapy	3	48	3
other	Congestive heart failure	Cardiac disorders	Sham Nocturnal Oxygen Therapy	2	50	2
serious	2019 novel coronavirus infection	Infections and infestations	Nocturnal Oxygen Therapy	2	48	2
serious	2019 novel coronavirus infection	Infections and infestations	Sham Nocturnal Oxygen Therapy	0	50	0
serious	Abdominal pain	Gastrointestinal disorders	Nocturnal Oxygen Therapy	1	48	1
serious	Abdominal pain	Gastrointestinal disorders	Sham Nocturnal Oxygen Therapy	1	50	2
serious	Acute decompensated heart failure	Cardiac disorders	Nocturnal Oxygen Therapy	4	48	5
serious	Acute decompensated heart failure	Cardiac disorders	Sham Nocturnal Oxygen Therapy	0	50	0

1 to 10 of 144Source ClinicalTrials.gov

See all 144 adverse events

Adverse event totals6

The totals the trial posted for each group.

Total	Group	Affected	At risk
Total, all-cause mortality	Nocturnal Oxygen Therapy	6	48
Total, all-cause mortality	Sham Nocturnal Oxygen Therapy	6	50
Total, other adverse events	Nocturnal Oxygen Therapy	6	48
Total, other adverse events	Sham Nocturnal Oxygen Therapy	5	50
Total, serious adverse events	Nocturnal Oxygen Therapy	26	48
Total, serious adverse events	Sham Nocturnal Oxygen Therapy	22	50

Source ClinicalTrials.gov

Papers1

The papers the trial lists on ClinicalTrials.gov.

PMID	Listed as
40929650	DERIVED

Source PubMed

Grants1

The grants NIH RePORTER links to the trial, newest funded first: NIH's, and some of AHRQ's, CDC's, FDA's and VA's. Each shows its title, principal investigators, organization and funder in its newest year.

Project	Title	Principal investigators	Organization	Funder	Fiscal years
U24HL140412	Impact of Low Flow Nocturnal Oxygen Therapy On Hospital Admissions and Mortality in Patients with Heart Failure and Central Sleep Apnea - DCC	REDLINE, SUSAN S.; WANG, RUI	BRIGHAM AND WOMEN'S HOSPITAL	NATIONAL HEART, LUNG, AND BLOOD INSTITUTE	2018 to 2020

Source NIH RePORTER

Trial comparisons3

Comparisons of the trial's two groups, calculated by ConductScience from the counts it posted.

Comparison	Source
Nocturnal Oxygen Therapy vs Sham Nocturnal Oxygen Therapy: First Occurrence of Mortality Due to Any Cause or an Unplanned Hospitalization for Worsening Heart Failure or a Life-saving Cardiovascular (CV) Intervention	Trial comparisons
Nocturnal Oxygen Therapy vs Sham Nocturnal Oxygen Therapy: deaths from any cause	Trial comparisons
Nocturnal Oxygen Therapy vs Sham Nocturnal Oxygen Therapy: serious adverse events	Trial comparisons

Tests0

The ConductCognition tests this trial's registered outcomes name, as ScienceGraph matched them in trial-tests-2026-11-12-0.2.1.

None in this release.

Data dates

The day each source was copied for this release.

ClinicalTrials.gov: 2026-11-12; ClinicalTrials.gov
Results, from AACT: 2026-03-23; AACT
NIH grant links: 2026-11-13; NIH RePORTER

Sources 3

ClinicalTrials.gov's posted results, through CTTI's AACTFreely available. Acknowledgement requested
ClinicalTrials.govNo license stated
NIH RePORTER's clinical studies and project filesPublic domain

Each source's terms

ClinicalTrials.gov's posted results, through CTTI's AACTClinicalTrials.gov data via Aggregate Analysis of ClinicalTrials.gov (AACT), CTTI. CTTI makes its materials freely available and requests acknowledgement. https://aact.ctti-clinicaltrials.org/documentation/299
ClinicalTrials.govnone stated
NIH RePORTER's clinical studies and project filesPublic domain (NIH RePORTER)

ClinicalTrials.gov's data carry an international copyright outside the United States: https://clinicaltrials.gov/about-site/terms-conditions.

For software

Read this trial from software.

The record and each of its lists are JSON, twenty rows a page. No key.

GET https://conductscience.org/api/trials/v1/NCT03745898

GET https://conductscience.org/api/trials/v1/NCT03745898/events?page=2

API reference For AI assistants