NEON: North East Oxygen Network study

Does home oxygen therapy (HOT) in addition to standard care improve disease severity and symptoms in chronic heart failure?

Status

Active, not recruiting

Phases

Unknown

Study type

Interventional

Source

ISRCTN

Registry ID

ISRCTN60260702

Enrollment

Registered

2008-07-14

Start date

2010-01-01

Completion date

Unknown

Last updated

2016-10-17

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Heart failure Circulatory System Heart failure

Interventions

The participants will be randomised to receive HOT as nocturnal oxygen therapy (NOT) or long-term oxygen treatment (LTOT). Once randomised to one of the two modes of oxygen delivery, there will be a s

Eligibility

Sex/Gender

All

Inclusion criteria

Inclusion criteria: 1. Both males and females, aged 18 years or over 2. Heart failure grade NYHA III/IV with left ventricular (LV) systolic dysfunction confirmed by echocardiography. The left ventricular ejection fraction must be less than 40% or graded as at least "moderately" impaired on visual inspection if an accurate ejection fraction cannot be calculated 3. Heart failure from any aetiology 4. Maximally tolerated medical management of their heart failure 5. Provided written informed consent and able to complete patient assessments

Exclusion criteria

Exclusion criteria: Patients who: 1. Are unable to provide informed consent 2. Are unable to complete patient related information on entry 3. Have chronic obstructive pulmonary disease (COPD) likely to fulfil criteria for long-term oxygen treatment (LTOT); forced expiratory volume in 1 second (FEV1)/forced vital capacity (FVC) <70% and FEV1 <40% predicted and hypoxia (pO2 <7.3 kPa or saturations <90%) 4. Have co-existing malignant disease if this would affect the study in the investigators' opinion 5. Patients with persistent basal pulmonary crackles found to have interstitial lung disease 6. Unwilling or unable to comply with safety regulations regarding oxygen use, particularly smoking

Design outcomes

Primary

Measure	Time frame
To assess the feasibility of the proposed randomised control trial in the following regard: 1. Prevalence of hypoxaemia in patients with NYHA III/IV and optimal medical therapy. Assessment of arterial oxygenation by: 1.1. Arterial saturation by pulse oximetry at baseline and at the completion of the 6 minute walk test 1.2. Overnight oximetry using the Embletta® to record (i) nadir of oxygenation overnight (ii) proportion of night time spent with oxygen saturation below 95% 2. Recruitment and retention of study patients and their compliance with trial intervention. Criteria for proceeding to the larger RCT phase of the study: 2.1. Recruitment rate >= 3 patients per week per centre during the recruitment phase 2.2. Drop out rate (excluding deaths) of = 27% Number of hours of oxygen used will be measured by concentrator meter and patient diaries. 3. The value of the intervention for a preliminary cost-effectiveness analysis: Minnesota Living with Heart Failure (MLwHF) quality of life questionnaire scores at baseline, 1 and 3 months. 4. To develop a cost-effectiveness model of HOT based on existing evidence (to asses the likely benefit of proceeding to the larger RCT phase of the study) 5. Expected value of perfect information (EVPI) associated with the data to be collected in the proposed trial, that is, whether the patient benefits from the improvement in treatment decisions possible with the additional information provided by the trial is worth the cost of undertaking a definitive clinical trial of this intervention. To use this to inform the design of the subsequent main trial.	—

Measure

Time frame

To assess the feasibility of the proposed randomised control trial in the following regard: 1. Prevalence of hypoxaemia in patients with NYHA III/IV and optimal medical therapy. Assessment of arterial oxygenation by: 1.1. Arterial saturation by pulse oximetry at baseline and at the completion of the 6 minute walk test 1.2. Overnight oximetry using the Embletta® to record (i) nadir of oxygenation overnight (ii) proportion of night time spent with oxygen saturation below 95% 2. Recruitment and retention of study patients and their compliance with trial intervention. Criteria for proceeding to the larger RCT phase of the study: 2.1. Recruitment rate >= 3 patients per week per centre during the recruitment phase 2.2. Drop out rate (excluding deaths) of = 27% Number of hours of oxygen used will be measured by concentrator meter and patient diaries. 3. The value of the intervention for a preliminary cost-effectiveness analysis: Minnesota Living with Heart Failure (MLwHF) quality of life questionnaire scores at baseline, 1 and 3 months. 4. To develop a cost-effectiveness model of HOT based on existing evidence (to asses the likely benefit of proceeding to the larger RCT phase of the study) 5. Expected value of perfect information (EVPI) associated with the data to be collected in the proposed trial, that is, whether the patient benefits from the improvement in treatment decisions possible with the additional information provided by the trial is worth the cost of undertaking a definitive clinical trial of this intervention. To use this to inform the design of the subsequent main trial.

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Secondary

Measure	Time frame
1. To assess the effect of HOT delivered as NOT or LTOT on the following: 1.1. Symptoms (total duration of follow-up: 3 months): a. Assessed using the results of standard biochemistry tests b. 6 minute walk test c. Prevalence of hypoxaemia results d. Validated Borg score and Numerical Rating Scale (NRS) for breathlessness (average and worse over past 24 hours and current level) d. Change in validated Karnofsky performance scale of physical activity e. Epworth Sleepiness score to assess daytime somnolence f. Co-morbidity measured by the Charlson co-morbidity index 1.2. Quality of life, as measured by MLWHF, Hospital Anxiety and Depression (HAD) (mood assessment) and EuroQoL questionnaires at baseline, 1 and 3 months 1.3. Disease severity in patients with CHF, as measured by the validated Borg score and NRS for breathlessness (average and worse over past 24 hours and current level). Total duration of follow-up: 3 months 2. To assess the cost-effectiveness of HOT (see 3 in Primary outcome measures) 3. To assess the acceptability to patients and carers of study intervention and placebo device (Patient diary at enrolment, 1 and 3 months) 4. To assess the acceptability of the placebo device to clinicians (through communications with the research teams)	—

Measure

Time frame

1. To assess the effect of HOT delivered as NOT or LTOT on the following: 1.1. Symptoms (total duration of follow-up: 3 months): a. Assessed using the results of standard biochemistry tests b. 6 minute walk test c. Prevalence of hypoxaemia results d. Validated Borg score and Numerical Rating Scale (NRS) for breathlessness (average and worse over past 24 hours and current level) d. Change in validated Karnofsky performance scale of physical activity e. Epworth Sleepiness score to assess daytime somnolence f. Co-morbidity measured by the Charlson co-morbidity index 1.2. Quality of life, as measured by MLWHF, Hospital Anxiety and Depression (HAD) (mood assessment) and EuroQoL questionnaires at baseline, 1 and 3 months 1.3. Disease severity in patients with CHF, as measured by the validated Borg score and NRS for breathlessness (average and worse over past 24 hours and current level). Total duration of follow-up: 3 months 2. To assess the cost-effectiveness of HOT (see 3 in Primary outcome measures) 3. To assess the acceptability to patients and carers of study intervention and placebo device (Patient diary at enrolment, 1 and 3 months) 4. To assess the acceptability of the placebo device to clinicians (through communications with the research teams)

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Countries

United Kingdom

Outcome results

None listed

Source: ISRCTN (via WHO ICTRP) · Data processed: Mar 15, 2026