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Nocturnal Oxygen Treatment in Heart Failure and Cheyne-Stokes Respiration

Nocturnal Oxygen Treatment in Heart Failure and Cheyne-Stokes Respiration. A Randomized Double-Blind Placebo Controlled Cross-Over Study

Status
Completed
Phases
NA
Study type
Interventional
Source
ClinicalTrials.gov
Registry ID
NCT00338078
Enrollment
62
Registered
2006-06-20
Start date
1999-03-31
Completion date
2006-12-31
Last updated
2008-07-02

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

Conditions

Heart Failure

Brief summary

The purpose of this study is to determine whether oxygen therapy during sleep improves quality of life, exercise capacity and heart function among patients with chronic heart failure and central sleep apnea.

Detailed description

Oxygen therapy reduces the number of central apneas among patients with congestive heart failure but it is unknown whether quality of life and heart function also improve. We aim to test whether the quality of life, exercise capacity and heart function are improved with nocturnal oxygen therapy during 6 weeks with nocturnal oxygen from oxygen concentrator or nocturnal air from placebo concentrator.

Interventions

DEVICEnocturnal oxygen treatment from oxygen concentrators

Sponsors

Umeå University
Lead SponsorOTHER

Study design

Allocation
RANDOMIZED
Intervention model
CROSSOVER
Primary purpose
TREATMENT
Masking
QUADRUPLE (Subject, Caregiver, Investigator, Outcomes Assessor)

Eligibility

Sex/Gender
ALL
Age
19 Years to 90 Years
Healthy volunteers
No

Inclusion criteria

* Stable heart failure with left ventricular dysfunction * Cheyne-Stokes respiration with central AHI\>15 and obstructive AHI\<5

Exclusion criteria

* Heart infarction within 3 months. * Dementia * Chronic obstructive pulmonary disease and daytime hypoxemia.

Design outcomes

Primary

MeasureTime frame
Exercise capacity
Quality of life (SF-36, Minnesota, Living with heart failure questionnaire)
Brain natriuretic peptide (BNP)

Secondary

MeasureTime frame
Hospitality anxiety and depression scale
Epworth sleepiness scale
Karolinska sleepiness scale
Routine lab (haemoglobins, thyroid status, creatinin)
Echocardiography
Urinary cortisol
Polysomnography
Arrhythmias from 24 hour Holter-ECG registration
Heart rate variability
Urinary catecholamines
Radionuclide determination of ejection fraction
Mortality and hospitalization for cardiovascular causes (combined and individually)

Countries

Sweden

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026