Trial Outcomes & Findings for The Impact of Low Flow Nocturnal Oxygen Therapy on Hospital Admissions and Mortality in Patients With Heart Failure and Central Sleep Apnea (NCT NCT03745898)

NCT ID: NCT03745898

Last Updated: 2023-08-01

Results Overview

This is a composite primary outcome

• Recruitment status: TERMINATED
• Study phase: PHASE3
• Target enrollment: 98 participants
• Primary outcome timeframe: 12 months
• Results posted on: 2023-08-01

Participant Flow

Participant milestones

Measure	Nocturnal Oxygen Therapy Active nocturnal oxygen therapy Oxygen: Active nocturnal oxygen concentrator	Sham Nocturnal Oxygen Therapy Sham nocturnal oxygen therapy (room air) Room Air: Sham nocturnal oxygen concentrator (room air)
Overall Study STARTED	48	50
Overall Study COMPLETED	48	50
Overall Study NOT COMPLETED	0	0

Reasons for withdrawal

Withdrawal data not reported

Baseline Characteristics

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

Baseline characteristics by cohort

Measure	Nocturnal Oxygen Therapy n=48 Participants Active nocturnal oxygen therapy Oxygen: Active nocturnal oxygen concentrator	Sham Nocturnal Oxygen Therapy n=50 Participants Sham nocturnal oxygen therapy (room air) Room Air: Sham nocturnal oxygen concentrator (room air)	Total n=98 Participants Total of all reporting groups
Age, Categorical <=18 years	0 Participants n=5 Participants	0 Participants n=7 Participants	0 Participants n=5 Participants
Age, Categorical Between 18 and 65 years	35 Participants n=5 Participants	28 Participants n=7 Participants	63 Participants n=5 Participants
Age, Categorical >=65 years	13 Participants n=5 Participants	22 Participants n=7 Participants	35 Participants n=5 Participants
Age, Continuous	60.56 years STANDARD_DEVIATION 12.22 • n=5 Participants	62.78 years STANDARD_DEVIATION 11.12 • n=7 Participants	61.69 years STANDARD_DEVIATION 11.67 • n=5 Participants
Sex: Female, Male Female	12 Participants n=5 Participants	11 Participants n=7 Participants	23 Participants n=5 Participants
Sex: Female, Male Male	36 Participants n=5 Participants	39 Participants n=7 Participants	75 Participants n=5 Participants
Race (NIH/OMB) American Indian or Alaska Native	0 Participants n=5 Participants	1 Participants n=7 Participants	1 Participants n=5 Participants
Race (NIH/OMB) Asian	0 Participants n=5 Participants	0 Participants n=7 Participants	0 Participants n=5 Participants
Race (NIH/OMB) Native Hawaiian or Other Pacific Islander	0 Participants n=5 Participants	0 Participants n=7 Participants	0 Participants n=5 Participants
Race (NIH/OMB) Black or African American	18 Participants n=5 Participants	10 Participants n=7 Participants	28 Participants n=5 Participants
Race (NIH/OMB) White	29 Participants n=5 Participants	37 Participants n=7 Participants	66 Participants n=5 Participants
Race (NIH/OMB) More than one race	0 Participants n=5 Participants	0 Participants n=7 Participants	0 Participants n=5 Participants
Race (NIH/OMB) Unknown or Not Reported	1 Participants n=5 Participants	2 Participants n=7 Participants	3 Participants n=5 Participants
Region of Enrollment United States	48 Participants n=5 Participants	50 Participants n=7 Participants	98 Participants n=5 Participants

PRIMARY outcome

Timeframe: 12 months

Population: Recruitment incomplete due to early termination

This is a composite primary outcome

Outcome measures

Measure	Nocturnal Oxygen Therapy n=48 Participants Active nocturnal oxygen therapy Oxygen: Active nocturnal oxygen concentrator	Sham Nocturnal Oxygen Therapy n=50 Participants Sham nocturnal oxygen therapy (room air) Room Air: Sham nocturnal oxygen concentrator (room air)
First Occurrence of Mortality Due to Any Cause or an Unplanned Hospitalization for Worsening Heart Failure or a Life-saving Cardiovascular (CV) Intervention	15 Participants	9 Participants

SECONDARY outcome

Timeframe: From enrollment to study termination, attrition or death. Min = 41 days, Max = 626 Days

Population: Incomplete due to early termination

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)

Outcome measures

Measure	Nocturnal Oxygen Therapy n=48 Participants Active nocturnal oxygen therapy Oxygen: Active nocturnal oxygen concentrator	Sham Nocturnal Oxygen Therapy n=50 Participants Sham nocturnal oxygen therapy (room air) Room Air: Sham nocturnal oxygen concentrator (room air)
Recurrent Event Analyses of Mortality and Morbidity	22 events	18 events

SECONDARY outcome

Timeframe: Baseline, 6 month follow up

Population: Incomplete due to early termination

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.

Outcome measures

Measure	Nocturnal Oxygen Therapy n=34 Participants Active nocturnal oxygen therapy Oxygen: Active nocturnal oxygen concentrator	Sham Nocturnal Oxygen Therapy n=38 Participants Sham nocturnal oxygen therapy (room air) Room Air: Sham nocturnal oxygen concentrator (room air)
Quality of Life and Symptoms - HF Disease-specific Quality of Life	7.19 score on a scale Standard Deviation 22.32	4.83 score on a scale Standard Deviation 13.43

SECONDARY outcome

Timeframe: Baseline, 6 month follow up

Population: Incomplete due to early termination

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.

Outcome measures

Measure	Nocturnal Oxygen Therapy n=34 Participants Active nocturnal oxygen therapy Oxygen: Active nocturnal oxygen concentrator	Sham Nocturnal Oxygen Therapy n=38 Participants Sham nocturnal oxygen therapy (room air) Room Air: Sham nocturnal oxygen concentrator (room air)
Quality of Life and Symptoms - Generic-quality of Life	0.06 score on a scale Standard Deviation 0.19	0.02 score on a scale Standard Deviation 0.11

SECONDARY outcome

Timeframe: Baseline, 6 month follow up

Population: Incomplete due to early termination

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.

Outcome measures

Measure	Nocturnal Oxygen Therapy n=33 Participants Active nocturnal oxygen therapy Oxygen: Active nocturnal oxygen concentrator	Sham Nocturnal Oxygen Therapy n=38 Participants Sham nocturnal oxygen therapy (room air) Room Air: Sham nocturnal oxygen concentrator (room air)
Quality of Life and Symptoms - Depressive Symptoms	-2.21 score on a scale Standard Deviation 5.01	-1.61 score on a scale Standard Deviation 5.85

SECONDARY outcome

Timeframe: Baseline, 6 month follow up

Population: Incomplete due to early termination

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.

Outcome measures

Measure	Nocturnal Oxygen Therapy n=32 Participants Active nocturnal oxygen therapy Oxygen: Active nocturnal oxygen concentrator	Sham Nocturnal Oxygen Therapy n=37 Participants Sham nocturnal oxygen therapy (room air) Room Air: Sham nocturnal oxygen concentrator (room air)
Quality of Life and Symptoms - Sleep Symptoms and Sleep Related Daytime Impairment Change in Sleep Disturbance Scale T-score	-6.26 score on a scale Standard Deviation 7.77	-4.98 score on a scale Standard Deviation 8.32
Quality of Life and Symptoms - Sleep Symptoms and Sleep Related Daytime Impairment Change in Sleep Related Impairment Scale T-score	-5.69 score on a scale Standard Deviation 9.42	-4.20 score on a scale Standard Deviation 12.62

SECONDARY outcome

Timeframe: Baseline, 6 month follow up

Population: Incomplete due to early termination

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.

Outcome measures

Measure	Nocturnal Oxygen Therapy n=31 Participants Active nocturnal oxygen therapy Oxygen: Active nocturnal oxygen concentrator	Sham Nocturnal Oxygen Therapy n=35 Participants Sham nocturnal oxygen therapy (room air) Room Air: Sham nocturnal oxygen concentrator (room air)
Functional Status	-0.16 score on a scale Standard Deviation 0.52	-0.03 score on a scale Standard Deviation 0.57

Adverse Events

Nocturnal Oxygen Therapy

Serious events: 26 serious events

Other events: 6 other events

Deaths: 6 deaths

Sham Nocturnal Oxygen Therapy

Serious events: 22 serious events

Other events: 5 other events

Deaths: 6 deaths

Serious adverse events

Measure	Nocturnal Oxygen Therapy n=48 participants at risk Active nocturnal oxygen therapy Oxygen: Active nocturnal oxygen concentrator	Sham Nocturnal Oxygen Therapy n=50 participants at risk Sham nocturnal oxygen therapy (room air) Room Air: Sham nocturnal oxygen concentrator (room air)
Infections and infestations 2019 novel coronavirus infection	4.2% 2/48 • Number of events 2 • Participants were monitored for adverse events from study enrollment through all follow-up study visits (baseline, 3 month, 6 month, 9 month 12 month, 18 month, 24 month) until study termination.	0.00% 0/50 • Participants were monitored for adverse events from study enrollment through all follow-up study visits (baseline, 3 month, 6 month, 9 month 12 month, 18 month, 24 month) until study termination.
Gastrointestinal disorders Abdominal pain	2.1% 1/48 • Number of events 1 • Participants were monitored for adverse events from study enrollment through all follow-up study visits (baseline, 3 month, 6 month, 9 month 12 month, 18 month, 24 month) until study termination.	2.0% 1/50 • Number of events 2 • Participants were monitored for adverse events from study enrollment through all follow-up study visits (baseline, 3 month, 6 month, 9 month 12 month, 18 month, 24 month) until study termination.
Cardiac disorders Acute decompensated heart failure	8.3% 4/48 • Number of events 5 • Participants were monitored for adverse events from study enrollment through all follow-up study visits (baseline, 3 month, 6 month, 9 month 12 month, 18 month, 24 month) until study termination.	0.00% 0/50 • Participants were monitored for adverse events from study enrollment through all follow-up study visits (baseline, 3 month, 6 month, 9 month 12 month, 18 month, 24 month) until study termination.
Renal and urinary disorders Acute kidney injury	2.1% 1/48 • Number of events 2 • Participants were monitored for adverse events from study enrollment through all follow-up study visits (baseline, 3 month, 6 month, 9 month 12 month, 18 month, 24 month) until study termination.	0.00% 0/50 • Participants were monitored for adverse events from study enrollment through all follow-up study visits (baseline, 3 month, 6 month, 9 month 12 month, 18 month, 24 month) until study termination.
Renal and urinary disorders Acute renal failure	0.00% 0/48 • Participants were monitored for adverse events from study enrollment through all follow-up study visits (baseline, 3 month, 6 month, 9 month 12 month, 18 month, 24 month) until study termination.	2.0% 1/50 • Number of events 1 • Participants were monitored for adverse events from study enrollment through all follow-up study visits (baseline, 3 month, 6 month, 9 month 12 month, 18 month, 24 month) until study termination.
Blood and lymphatic system disorders Anemia	2.1% 1/48 • Number of events 1 • Participants were monitored for adverse events from study enrollment through all follow-up study visits (baseline, 3 month, 6 month, 9 month 12 month, 18 month, 24 month) until study termination.	2.0% 1/50 • Number of events 1 • Participants were monitored for adverse events from study enrollment through all follow-up study visits (baseline, 3 month, 6 month, 9 month 12 month, 18 month, 24 month) until study termination.
Investigations Angiogram	2.1% 1/48 • Number of events 1 • Participants were monitored for adverse events from study enrollment through all follow-up study visits (baseline, 3 month, 6 month, 9 month 12 month, 18 month, 24 month) until study termination.	0.00% 0/50 • Participants were monitored for adverse events from study enrollment through all follow-up study visits (baseline, 3 month, 6 month, 9 month 12 month, 18 month, 24 month) until study termination.
Cardiac disorders Atrial fibrillation	0.00% 0/48 • Participants were monitored for adverse events from study enrollment through all follow-up study visits (baseline, 3 month, 6 month, 9 month 12 month, 18 month, 24 month) until study termination.	2.0% 1/50 • Number of events 1 • Participants were monitored for adverse events from study enrollment through all follow-up study visits (baseline, 3 month, 6 month, 9 month 12 month, 18 month, 24 month) until study termination.
Cardiac disorders Atrial flutter	2.1% 1/48 • Number of events 1 • Participants were monitored for adverse events from study enrollment through all follow-up study visits (baseline, 3 month, 6 month, 9 month 12 month, 18 month, 24 month) until study termination.	0.00% 0/50 • Participants were monitored for adverse events from study enrollment through all follow-up study visits (baseline, 3 month, 6 month, 9 month 12 month, 18 month, 24 month) until study termination.
Surgical and medical procedures Biventricular cardioverter defibrillator replacement	2.1% 1/48 • Number of events 1 • Participants were monitored for adverse events from study enrollment through all follow-up study visits (baseline, 3 month, 6 month, 9 month 12 month, 18 month, 24 month) until study termination.	0.00% 0/50 • Participants were monitored for adverse events from study enrollment through all follow-up study visits (baseline, 3 month, 6 month, 9 month 12 month, 18 month, 24 month) until study termination.
Respiratory, thoracic and mediastinal disorders Bronchitis viral	0.00% 0/48 • Participants were monitored for adverse events from study enrollment through all follow-up study visits (baseline, 3 month, 6 month, 9 month 12 month, 18 month, 24 month) until study termination.	2.0% 1/50 • Number of events 1 • Participants were monitored for adverse events from study enrollment through all follow-up study visits (baseline, 3 month, 6 month, 9 month 12 month, 18 month, 24 month) until study termination.
Surgical and medical procedures Cardiac ablation	0.00% 0/48 • Participants were monitored for adverse events from study enrollment through all follow-up study visits (baseline, 3 month, 6 month, 9 month 12 month, 18 month, 24 month) until study termination.	4.0% 2/50 • Number of events 2 • Participants were monitored for adverse events from study enrollment through all follow-up study visits (baseline, 3 month, 6 month, 9 month 12 month, 18 month, 24 month) until study termination.
Investigations Cardiac catheterization	4.2% 2/48 • Number of events 2 • Participants were monitored for adverse events from study enrollment through all follow-up study visits (baseline, 3 month, 6 month, 9 month 12 month, 18 month, 24 month) until study termination.	0.00% 0/50 • Participants were monitored for adverse events from study enrollment through all follow-up study visits (baseline, 3 month, 6 month, 9 month 12 month, 18 month, 24 month) until study termination.
Cardiac disorders Cardiac death	0.00% 0/48 • Participants were monitored for adverse events from study enrollment through all follow-up study visits (baseline, 3 month, 6 month, 9 month 12 month, 18 month, 24 month) until study termination.	2.0% 1/50 • Number of events 1 • Participants were monitored for adverse events from study enrollment through all follow-up study visits (baseline, 3 month, 6 month, 9 month 12 month, 18 month, 24 month) until study termination.
Surgical and medical procedures Cardiac pacemaker insertion	0.00% 0/48 • Participants were monitored for adverse events from study enrollment through all follow-up study visits (baseline, 3 month, 6 month, 9 month 12 month, 18 month, 24 month) until study termination.	2.0% 1/50 • Number of events 1 • Participants were monitored for adverse events from study enrollment through all follow-up study visits (baseline, 3 month, 6 month, 9 month 12 month, 18 month, 24 month) until study termination.
Product Issues Cardiac pacemaker malfunction	2.1% 1/48 • Number of events 1 • Participants were monitored for adverse events from study enrollment through all follow-up study visits (baseline, 3 month, 6 month, 9 month 12 month, 18 month, 24 month) until study termination.	0.00% 0/50 • Participants were monitored for adverse events from study enrollment through all follow-up study visits (baseline, 3 month, 6 month, 9 month 12 month, 18 month, 24 month) until study termination.
Cardiac disorders Chest pain	2.1% 1/48 • Number of events 2 • Participants were monitored for adverse events from study enrollment through all follow-up study visits (baseline, 3 month, 6 month, 9 month 12 month, 18 month, 24 month) until study termination.	0.00% 0/50 • Participants were monitored for adverse events from study enrollment through all follow-up study visits (baseline, 3 month, 6 month, 9 month 12 month, 18 month, 24 month) until study termination.
General disorders Chest pain	2.1% 1/48 • Number of events 2 • Participants were monitored for adverse events from study enrollment through all follow-up study visits (baseline, 3 month, 6 month, 9 month 12 month, 18 month, 24 month) until study termination.	0.00% 0/50 • Participants were monitored for adverse events from study enrollment through all follow-up study visits (baseline, 3 month, 6 month, 9 month 12 month, 18 month, 24 month) until study termination.
Infections and infestations Clostridium difficile infection	0.00% 0/48 • Participants were monitored for adverse events from study enrollment through all follow-up study visits (baseline, 3 month, 6 month, 9 month 12 month, 18 month, 24 month) until study termination.	2.0% 1/50 • Number of events 1 • Participants were monitored for adverse events from study enrollment through all follow-up study visits (baseline, 3 month, 6 month, 9 month 12 month, 18 month, 24 month) until study termination.
Cardiac disorders Congestive heart failure	6.2% 3/48 • Number of events 6 • Participants were monitored for adverse events from study enrollment through all follow-up study visits (baseline, 3 month, 6 month, 9 month 12 month, 18 month, 24 month) until study termination.	8.0% 4/50 • Number of events 4 • Participants were monitored for adverse events from study enrollment through all follow-up study visits (baseline, 3 month, 6 month, 9 month 12 month, 18 month, 24 month) until study termination.
Cardiac disorders Coronary artery disease	2.1% 1/48 • Number of events 1 • Participants were monitored for adverse events from study enrollment through all follow-up study visits (baseline, 3 month, 6 month, 9 month 12 month, 18 month, 24 month) until study termination.	0.00% 0/50 • Participants were monitored for adverse events from study enrollment through all follow-up study visits (baseline, 3 month, 6 month, 9 month 12 month, 18 month, 24 month) until study termination.
Surgical and medical procedures Cryoablation	2.1% 1/48 • Number of events 1 • Participants were monitored for adverse events from study enrollment through all follow-up study visits (baseline, 3 month, 6 month, 9 month 12 month, 18 month, 24 month) until study termination.	0.00% 0/50 • Participants were monitored for adverse events from study enrollment through all follow-up study visits (baseline, 3 month, 6 month, 9 month 12 month, 18 month, 24 month) until study termination.
Surgical and medical procedures DC shock	0.00% 0/48 • Participants were monitored for adverse events from study enrollment through all follow-up study visits (baseline, 3 month, 6 month, 9 month 12 month, 18 month, 24 month) until study termination.	2.0% 1/50 • Number of events 1 • Participants were monitored for adverse events from study enrollment through all follow-up study visits (baseline, 3 month, 6 month, 9 month 12 month, 18 month, 24 month) until study termination.
General disorders Death	12.5% 6/48 • Number of events 6 • Participants were monitored for adverse events from study enrollment through all follow-up study visits (baseline, 3 month, 6 month, 9 month 12 month, 18 month, 24 month) until study termination.	8.0% 4/50 • Number of events 4 • Participants were monitored for adverse events from study enrollment through all follow-up study visits (baseline, 3 month, 6 month, 9 month 12 month, 18 month, 24 month) until study termination.
Cardiac disorders Decompensated heart failure	0.00% 0/48 • Participants were monitored for adverse events from study enrollment through all follow-up study visits (baseline, 3 month, 6 month, 9 month 12 month, 18 month, 24 month) until study termination.	2.0% 1/50 • Number of events 1 • Participants were monitored for adverse events from study enrollment through all follow-up study visits (baseline, 3 month, 6 month, 9 month 12 month, 18 month, 24 month) until study termination.
Endocrine disorders Diabetic foot ulcer	0.00% 0/48 • Participants were monitored for adverse events from study enrollment through all follow-up study visits (baseline, 3 month, 6 month, 9 month 12 month, 18 month, 24 month) until study termination.	4.0% 2/50 • Number of events 2 • Participants were monitored for adverse events from study enrollment through all follow-up study visits (baseline, 3 month, 6 month, 9 month 12 month, 18 month, 24 month) until study termination.
Gastrointestinal disorders Diveticulitis intestinal perforated	0.00% 0/48 • Participants were monitored for adverse events from study enrollment through all follow-up study visits (baseline, 3 month, 6 month, 9 month 12 month, 18 month, 24 month) until study termination.	2.0% 1/50 • Number of events 1 • Participants were monitored for adverse events from study enrollment through all follow-up study visits (baseline, 3 month, 6 month, 9 month 12 month, 18 month, 24 month) until study termination.
Vascular disorders Dizziness	0.00% 0/48 • Participants were monitored for adverse events from study enrollment through all follow-up study visits (baseline, 3 month, 6 month, 9 month 12 month, 18 month, 24 month) until study termination.	2.0% 1/50 • Number of events 1 • Participants were monitored for adverse events from study enrollment through all follow-up study visits (baseline, 3 month, 6 month, 9 month 12 month, 18 month, 24 month) until study termination.
Injury, poisoning and procedural complications Driver in motor vehicle accident	0.00% 0/48 • Participants were monitored for adverse events from study enrollment through all follow-up study visits (baseline, 3 month, 6 month, 9 month 12 month, 18 month, 24 month) until study termination.	2.0% 1/50 • Number of events 1 • Participants were monitored for adverse events from study enrollment through all follow-up study visits (baseline, 3 month, 6 month, 9 month 12 month, 18 month, 24 month) until study termination.
Cardiac disorders Edema lower limb	0.00% 0/48 • Participants were monitored for adverse events from study enrollment through all follow-up study visits (baseline, 3 month, 6 month, 9 month 12 month, 18 month, 24 month) until study termination.	2.0% 1/50 • Number of events 1 • Participants were monitored for adverse events from study enrollment through all follow-up study visits (baseline, 3 month, 6 month, 9 month 12 month, 18 month, 24 month) until study termination.
Gastrointestinal disorders Eosinophillic esophagitis	0.00% 0/48 • Participants were monitored for adverse events from study enrollment through all follow-up study visits (baseline, 3 month, 6 month, 9 month 12 month, 18 month, 24 month) until study termination.	2.0% 1/50 • Number of events 1 • Participants were monitored for adverse events from study enrollment through all follow-up study visits (baseline, 3 month, 6 month, 9 month 12 month, 18 month, 24 month) until study termination.
Respiratory, thoracic and mediastinal disorders Epistaxis	2.1% 1/48 • Number of events 1 • Participants were monitored for adverse events from study enrollment through all follow-up study visits (baseline, 3 month, 6 month, 9 month 12 month, 18 month, 24 month) until study termination.	0.00% 0/50 • Participants were monitored for adverse events from study enrollment through all follow-up study visits (baseline, 3 month, 6 month, 9 month 12 month, 18 month, 24 month) until study termination.
Injury, poisoning and procedural complications Fall	2.1% 1/48 • Number of events 1 • Participants were monitored for adverse events from study enrollment through all follow-up study visits (baseline, 3 month, 6 month, 9 month 12 month, 18 month, 24 month) until study termination.	6.0% 3/50 • Number of events 4 • Participants were monitored for adverse events from study enrollment through all follow-up study visits (baseline, 3 month, 6 month, 9 month 12 month, 18 month, 24 month) until study termination.
Infections and infestations Flu	2.1% 1/48 • Number of events 1 • Participants were monitored for adverse events from study enrollment through all follow-up study visits (baseline, 3 month, 6 month, 9 month 12 month, 18 month, 24 month) until study termination.	0.00% 0/50 • Participants were monitored for adverse events from study enrollment through all follow-up study visits (baseline, 3 month, 6 month, 9 month 12 month, 18 month, 24 month) until study termination.
Metabolism and nutrition disorders Fluid retention	0.00% 0/48 • Participants were monitored for adverse events from study enrollment through all follow-up study visits (baseline, 3 month, 6 month, 9 month 12 month, 18 month, 24 month) until study termination.	2.0% 1/50 • Number of events 1 • Participants were monitored for adverse events from study enrollment through all follow-up study visits (baseline, 3 month, 6 month, 9 month 12 month, 18 month, 24 month) until study termination.
Infections and infestations Gangrene toe	0.00% 0/48 • Participants were monitored for adverse events from study enrollment through all follow-up study visits (baseline, 3 month, 6 month, 9 month 12 month, 18 month, 24 month) until study termination.	2.0% 1/50 • Number of events 1 • Participants were monitored for adverse events from study enrollment through all follow-up study visits (baseline, 3 month, 6 month, 9 month 12 month, 18 month, 24 month) until study termination.
Gastrointestinal disorders GI bleed	0.00% 0/48 • Participants were monitored for adverse events from study enrollment through all follow-up study visits (baseline, 3 month, 6 month, 9 month 12 month, 18 month, 24 month) until study termination.	2.0% 1/50 • Number of events 1 • Participants were monitored for adverse events from study enrollment through all follow-up study visits (baseline, 3 month, 6 month, 9 month 12 month, 18 month, 24 month) until study termination.
Cardiac disorders Heart failure	4.2% 2/48 • Number of events 2 • Participants were monitored for adverse events from study enrollment through all follow-up study visits (baseline, 3 month, 6 month, 9 month 12 month, 18 month, 24 month) until study termination.	2.0% 1/50 • Number of events 2 • Participants were monitored for adverse events from study enrollment through all follow-up study visits (baseline, 3 month, 6 month, 9 month 12 month, 18 month, 24 month) until study termination.
Surgical and medical procedures Heart transplant	2.1% 1/48 • Number of events 1 • Participants were monitored for adverse events from study enrollment through all follow-up study visits (baseline, 3 month, 6 month, 9 month 12 month, 18 month, 24 month) until study termination.	0.00% 0/50 • Participants were monitored for adverse events from study enrollment through all follow-up study visits (baseline, 3 month, 6 month, 9 month 12 month, 18 month, 24 month) until study termination.
Endocrine disorders Hyperglycemia	4.2% 2/48 • Number of events 2 • Participants were monitored for adverse events from study enrollment through all follow-up study visits (baseline, 3 month, 6 month, 9 month 12 month, 18 month, 24 month) until study termination.	0.00% 0/50 • Participants were monitored for adverse events from study enrollment through all follow-up study visits (baseline, 3 month, 6 month, 9 month 12 month, 18 month, 24 month) until study termination.
Metabolism and nutrition disorders Hypokalaemia	0.00% 0/48 • Participants were monitored for adverse events from study enrollment through all follow-up study visits (baseline, 3 month, 6 month, 9 month 12 month, 18 month, 24 month) until study termination.	2.0% 1/50 • Number of events 1 • Participants were monitored for adverse events from study enrollment through all follow-up study visits (baseline, 3 month, 6 month, 9 month 12 month, 18 month, 24 month) until study termination.
Surgical and medical procedures Hysterectomy	2.1% 1/48 • Number of events 1 • Participants were monitored for adverse events from study enrollment through all follow-up study visits (baseline, 3 month, 6 month, 9 month 12 month, 18 month, 24 month) until study termination.	0.00% 0/50 • Participants were monitored for adverse events from study enrollment through all follow-up study visits (baseline, 3 month, 6 month, 9 month 12 month, 18 month, 24 month) until study termination.
Surgical and medical procedures Implantable cardioverter defibrillator insertion	2.1% 1/48 • Number of events 1 • Participants were monitored for adverse events from study enrollment through all follow-up study visits (baseline, 3 month, 6 month, 9 month 12 month, 18 month, 24 month) until study termination.	0.00% 0/50 • Participants were monitored for adverse events from study enrollment through all follow-up study visits (baseline, 3 month, 6 month, 9 month 12 month, 18 month, 24 month) until study termination.
General disorders Incarcerated hernia	0.00% 0/48 • Participants were monitored for adverse events from study enrollment through all follow-up study visits (baseline, 3 month, 6 month, 9 month 12 month, 18 month, 24 month) until study termination.	2.0% 1/50 • Number of events 1 • Participants were monitored for adverse events from study enrollment through all follow-up study visits (baseline, 3 month, 6 month, 9 month 12 month, 18 month, 24 month) until study termination.
Gastrointestinal disorders Inguinal hernia	0.00% 0/48 • Participants were monitored for adverse events from study enrollment through all follow-up study visits (baseline, 3 month, 6 month, 9 month 12 month, 18 month, 24 month) until study termination.	2.0% 1/50 • Number of events 1 • Participants were monitored for adverse events from study enrollment through all follow-up study visits (baseline, 3 month, 6 month, 9 month 12 month, 18 month, 24 month) until study termination.
Vascular disorders Lower gastrointestinal bleeding	2.1% 1/48 • Number of events 1 • Participants were monitored for adverse events from study enrollment through all follow-up study visits (baseline, 3 month, 6 month, 9 month 12 month, 18 month, 24 month) until study termination.	0.00% 0/50 • Participants were monitored for adverse events from study enrollment through all follow-up study visits (baseline, 3 month, 6 month, 9 month 12 month, 18 month, 24 month) until study termination.
Nervous system disorders Metabolic encephalopathy	0.00% 0/48 • Participants were monitored for adverse events from study enrollment through all follow-up study visits (baseline, 3 month, 6 month, 9 month 12 month, 18 month, 24 month) until study termination.	2.0% 1/50 • Number of events 1 • Participants were monitored for adverse events from study enrollment through all follow-up study visits (baseline, 3 month, 6 month, 9 month 12 month, 18 month, 24 month) until study termination.
Gastrointestinal disorders Nausea	2.1% 1/48 • Number of events 1 • Participants were monitored for adverse events from study enrollment through all follow-up study visits (baseline, 3 month, 6 month, 9 month 12 month, 18 month, 24 month) until study termination.	0.00% 0/50 • Participants were monitored for adverse events from study enrollment through all follow-up study visits (baseline, 3 month, 6 month, 9 month 12 month, 18 month, 24 month) until study termination.
Infections and infestations Necrotizing fasciitis	2.1% 1/48 • Number of events 1 • Participants were monitored for adverse events from study enrollment through all follow-up study visits (baseline, 3 month, 6 month, 9 month 12 month, 18 month, 24 month) until study termination.	0.00% 0/50 • Participants were monitored for adverse events from study enrollment through all follow-up study visits (baseline, 3 month, 6 month, 9 month 12 month, 18 month, 24 month) until study termination.
Cardiac disorders Non ST segment elevation myocardial infarction	2.1% 1/48 • Number of events 1 • Participants were monitored for adverse events from study enrollment through all follow-up study visits (baseline, 3 month, 6 month, 9 month 12 month, 18 month, 24 month) until study termination.	0.00% 0/50 • Participants were monitored for adverse events from study enrollment through all follow-up study visits (baseline, 3 month, 6 month, 9 month 12 month, 18 month, 24 month) until study termination.
Infections and infestations Otitis media	0.00% 0/48 • Participants were monitored for adverse events from study enrollment through all follow-up study visits (baseline, 3 month, 6 month, 9 month 12 month, 18 month, 24 month) until study termination.	2.0% 1/50 • Number of events 1 • Participants were monitored for adverse events from study enrollment through all follow-up study visits (baseline, 3 month, 6 month, 9 month 12 month, 18 month, 24 month) until study termination.
Cardiac disorders Palpitations	0.00% 0/48 • Participants were monitored for adverse events from study enrollment through all follow-up study visits (baseline, 3 month, 6 month, 9 month 12 month, 18 month, 24 month) until study termination.	2.0% 1/50 • Number of events 1 • Participants were monitored for adverse events from study enrollment through all follow-up study visits (baseline, 3 month, 6 month, 9 month 12 month, 18 month, 24 month) until study termination.
Infections and infestations Pneumonia	0.00% 0/48 • Participants were monitored for adverse events from study enrollment through all follow-up study visits (baseline, 3 month, 6 month, 9 month 12 month, 18 month, 24 month) until study termination.	2.0% 1/50 • Number of events 1 • Participants were monitored for adverse events from study enrollment through all follow-up study visits (baseline, 3 month, 6 month, 9 month 12 month, 18 month, 24 month) until study termination.
Infections and infestations Respiratory syncytial virus bronchitis	2.1% 1/48 • Number of events 1 • Participants were monitored for adverse events from study enrollment through all follow-up study visits (baseline, 3 month, 6 month, 9 month 12 month, 18 month, 24 month) until study termination.	0.00% 0/50 • Participants were monitored for adverse events from study enrollment through all follow-up study visits (baseline, 3 month, 6 month, 9 month 12 month, 18 month, 24 month) until study termination.
Infections and infestations Sepsis	0.00% 0/48 • Participants were monitored for adverse events from study enrollment through all follow-up study visits (baseline, 3 month, 6 month, 9 month 12 month, 18 month, 24 month) until study termination.	2.0% 1/50 • Number of events 1 • Participants were monitored for adverse events from study enrollment through all follow-up study visits (baseline, 3 month, 6 month, 9 month 12 month, 18 month, 24 month) until study termination.
Cardiac disorders Shortness of breath	2.1% 1/48 • Number of events 1 • Participants were monitored for adverse events from study enrollment through all follow-up study visits (baseline, 3 month, 6 month, 9 month 12 month, 18 month, 24 month) until study termination.	2.0% 1/50 • Number of events 1 • Participants were monitored for adverse events from study enrollment through all follow-up study visits (baseline, 3 month, 6 month, 9 month 12 month, 18 month, 24 month) until study termination.
Blood and lymphatic system disorders Sickle cell disease	2.1% 1/48 • Number of events 1 • Participants were monitored for adverse events from study enrollment through all follow-up study visits (baseline, 3 month, 6 month, 9 month 12 month, 18 month, 24 month) until study termination.	0.00% 0/50 • Participants were monitored for adverse events from study enrollment through all follow-up study visits (baseline, 3 month, 6 month, 9 month 12 month, 18 month, 24 month) until study termination.
Infections and infestations Sinusitis	2.1% 1/48 • Number of events 1 • Participants were monitored for adverse events from study enrollment through all follow-up study visits (baseline, 3 month, 6 month, 9 month 12 month, 18 month, 24 month) until study termination.	0.00% 0/50 • Participants were monitored for adverse events from study enrollment through all follow-up study visits (baseline, 3 month, 6 month, 9 month 12 month, 18 month, 24 month) until study termination.
Nervous system disorders Stroke	2.1% 1/48 • Number of events 1 • Participants were monitored for adverse events from study enrollment through all follow-up study visits (baseline, 3 month, 6 month, 9 month 12 month, 18 month, 24 month) until study termination.	0.00% 0/50 • Participants were monitored for adverse events from study enrollment through all follow-up study visits (baseline, 3 month, 6 month, 9 month 12 month, 18 month, 24 month) until study termination.
Vascular disorders Syncope	0.00% 0/48 • Participants were monitored for adverse events from study enrollment through all follow-up study visits (baseline, 3 month, 6 month, 9 month 12 month, 18 month, 24 month) until study termination.	4.0% 2/50 • Number of events 3 • Participants were monitored for adverse events from study enrollment through all follow-up study visits (baseline, 3 month, 6 month, 9 month 12 month, 18 month, 24 month) until study termination.
Surgical and medical procedures Tenotomy	0.00% 0/48 • Participants were monitored for adverse events from study enrollment through all follow-up study visits (baseline, 3 month, 6 month, 9 month 12 month, 18 month, 24 month) until study termination.	2.0% 1/50 • Number of events 1 • Participants were monitored for adverse events from study enrollment through all follow-up study visits (baseline, 3 month, 6 month, 9 month 12 month, 18 month, 24 month) until study termination.
Renal and urinary disorders Urinary retention	0.00% 0/48 • Participants were monitored for adverse events from study enrollment through all follow-up study visits (baseline, 3 month, 6 month, 9 month 12 month, 18 month, 24 month) until study termination.	2.0% 1/50 • Number of events 1 • Participants were monitored for adverse events from study enrollment through all follow-up study visits (baseline, 3 month, 6 month, 9 month 12 month, 18 month, 24 month) until study termination.
Infections and infestations Urinary tract infection	6.2% 3/48 • Number of events 3 • Participants were monitored for adverse events from study enrollment through all follow-up study visits (baseline, 3 month, 6 month, 9 month 12 month, 18 month, 24 month) until study termination.	2.0% 1/50 • Number of events 1 • Participants were monitored for adverse events from study enrollment through all follow-up study visits (baseline, 3 month, 6 month, 9 month 12 month, 18 month, 24 month) until study termination.
Cardiac disorders Ventricular fibrillation	0.00% 0/48 • Participants were monitored for adverse events from study enrollment through all follow-up study visits (baseline, 3 month, 6 month, 9 month 12 month, 18 month, 24 month) until study termination.	2.0% 1/50 • Number of events 2 • Participants were monitored for adverse events from study enrollment through all follow-up study visits (baseline, 3 month, 6 month, 9 month 12 month, 18 month, 24 month) until study termination.
Cardiac disorders Ventricular tachycardia	4.2% 2/48 • Number of events 2 • Participants were monitored for adverse events from study enrollment through all follow-up study visits (baseline, 3 month, 6 month, 9 month 12 month, 18 month, 24 month) until study termination.	2.0% 1/50 • Number of events 1 • Participants were monitored for adverse events from study enrollment through all follow-up study visits (baseline, 3 month, 6 month, 9 month 12 month, 18 month, 24 month) until study termination.
Nervous system disorders Vertigo	2.1% 1/48 • Number of events 1 • Participants were monitored for adverse events from study enrollment through all follow-up study visits (baseline, 3 month, 6 month, 9 month 12 month, 18 month, 24 month) until study termination.	0.00% 0/50 • Participants were monitored for adverse events from study enrollment through all follow-up study visits (baseline, 3 month, 6 month, 9 month 12 month, 18 month, 24 month) until study termination.
Cardiac disorders Volume overload	0.00% 0/48 • Participants were monitored for adverse events from study enrollment through all follow-up study visits (baseline, 3 month, 6 month, 9 month 12 month, 18 month, 24 month) until study termination.	2.0% 1/50 • Number of events 1 • Participants were monitored for adverse events from study enrollment through all follow-up study visits (baseline, 3 month, 6 month, 9 month 12 month, 18 month, 24 month) until study termination.
General disorders Weakness	0.00% 0/48 • Participants were monitored for adverse events from study enrollment through all follow-up study visits (baseline, 3 month, 6 month, 9 month 12 month, 18 month, 24 month) until study termination.	2.0% 1/50 • Number of events 1 • Participants were monitored for adverse events from study enrollment through all follow-up study visits (baseline, 3 month, 6 month, 9 month 12 month, 18 month, 24 month) until study termination.
Respiratory, thoracic and mediastinal disorders Whooping cough	2.1% 1/48 • Number of events 1 • Participants were monitored for adverse events from study enrollment through all follow-up study visits (baseline, 3 month, 6 month, 9 month 12 month, 18 month, 24 month) until study termination.	0.00% 0/50 • Participants were monitored for adverse events from study enrollment through all follow-up study visits (baseline, 3 month, 6 month, 9 month 12 month, 18 month, 24 month) until study termination.
Injury, poisoning and procedural complications Wound	0.00% 0/48 • Participants were monitored for adverse events from study enrollment through all follow-up study visits (baseline, 3 month, 6 month, 9 month 12 month, 18 month, 24 month) until study termination.	2.0% 1/50 • Number of events 1 • Participants were monitored for adverse events from study enrollment through all follow-up study visits (baseline, 3 month, 6 month, 9 month 12 month, 18 month, 24 month) until study termination.

Other adverse events

Measure	Nocturnal Oxygen Therapy n=48 participants at risk Active nocturnal oxygen therapy Oxygen: Active nocturnal oxygen concentrator	Sham Nocturnal Oxygen Therapy n=50 participants at risk Sham nocturnal oxygen therapy (room air) Room Air: Sham nocturnal oxygen concentrator (room air)
Infections and infestations 2019 novel coronavirus infection	6.2% 3/48 • Number of events 3 • Participants were monitored for adverse events from study enrollment through all follow-up study visits (baseline, 3 month, 6 month, 9 month 12 month, 18 month, 24 month) until study termination.	6.0% 3/50 • Number of events 3 • Participants were monitored for adverse events from study enrollment through all follow-up study visits (baseline, 3 month, 6 month, 9 month 12 month, 18 month, 24 month) until study termination.
Cardiac disorders Congestive heart failure	6.2% 3/48 • Number of events 3 • Participants were monitored for adverse events from study enrollment through all follow-up study visits (baseline, 3 month, 6 month, 9 month 12 month, 18 month, 24 month) until study termination.	4.0% 2/50 • Number of events 2 • Participants were monitored for adverse events from study enrollment through all follow-up study visits (baseline, 3 month, 6 month, 9 month 12 month, 18 month, 24 month) until study termination.

Additional Information

Dr. Susan Redline

Brigham and Women's Hospital

Phone: (617) 732-5500

Email: sredline@bwh.harvard.edu

Results disclosure agreements

• Principal investigator is a sponsor employee
• Publication restrictions are in place