Congestive Heart Failure, Sleep Disordered Breathing
Conditions
Brief summary
Respiratory insufficiencies during sleep can lead to reductions in the level of oxygen in the blood during the night, which has been shown to contribute to a range of morbidities. The purpose of this study is to assess the possibility that a nasal high flow therapy device may be able to treat respiratory insufficiencies, by stabilizing breathing and preventing reduction in blood oxygen. Heart failure patients will be screened at a heart failure clinic, and will be asked to undergo an overnight sleep study to determine is they exhibit respiratory insufficiencies during sleep. This sleep study may be completed in the sleep laboratory (attended polysomnography, PSG) or in-home (in-home polygraphy, PG). If they are diagnosed with respiratory insufficiencies, they will be asked to attend further overnight studies to see if treatment with nasal high flow therapy can be used to stabilize breathing.
Interventions
DEVICENasal High flow therapy device
Nasal high flow therapy via nasal cannula.
Sponsors
Fisher and Paykel Healthcare
Study design
Allocation
NA
Intervention model
SINGLE_GROUP
Primary purpose
BASIC_SCIENCE
Masking
NONE
Eligibility
Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
No
Inclusion criteria
* Men and Women aged ≥ 18 years * Heart Failure from ischemic or non-ischemic dilated cardiomyopathy for ≥ 6 months * Left ventricular systolic dysfunction (LVEF ≤45% by echocardiography performed within 3 months of the screening visit, or if not within 3 months, a justification provided by the cardiologist for why a repeat echocardiography is not required, for example, because the subject's condition has remained stable since their echocardiography). All echocardiography must be within a maximum of 1 year of the screening visit. * New York Heart Association Class II or III after optimization of medical therapy * Stable Clinical Status on stable optimal medical therapy for ≥ 1 month before entry
Exclusion criteria
* Unstable angina * Myocardial infarction within the last 12 months * Cardiac surgery within the previous 6 months * Pregnancy * Unwilling or unable to provide informed consent * Uncontrolled arrhythmias * Severe valvular heart disease * Current/prior use of mechanical ventilation (including CPAP). At the investigator's discretion.
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Treatment Efficacy | During 1 night of Sleep on PSG | The primary endpoint of the trial is to the efficacy of using nasal high flow therapy to stabilize breathing, as measured by the breath flow signal from PSG. |
Countries
New Zealand
Participant flow
Participants by arm
| Arm | Count |
|---|---|
| Diagnostic PSG/PG, PSG w. Nasal High Flow Therapy All patients recruited will undergo a diagnostic sleep study, either a full in laboratory attended polysomnography (PSG), or an in-home polygraphy (PG). If respiratory insufficiencies are detected, these patients will undergo an overnight in laboratory attended PSG on a nasal high flow therapy device to test the primary endpoint of this study. Patients without respiratory insufficiencies after the first PSG/PG will take no further part in the trial.
Nasal High flow therapy device: Nasal high flow therapy via nasal cannula. | 3 |
| Total | 3 |
Withdrawals & dropouts
| Period | Reason | FG000 |
|---|---|---|
| Overall Study | Lost to Follow-up | 1 |
| Overall Study | Withdrawal by Subject | 2 |
Baseline characteristics
| Characteristic | Diagnostic PSG/PG, PSG w. Nasal High Flow Therapy |
|---|---|
| Age, Continuous | 56.3 years STANDARD_DEVIATION 8.73 |
| Sex: Female, Male Female | 0 Participants |
| Sex: Female, Male Male | 3 Participants |
Adverse events
| Event type | EG000 affected / at risk |
|---|---|
| deaths Total, all-cause mortality | — / — |
| other Total, other adverse events | 0 / 6 |
| serious Total, serious adverse events | 0 / 6 |
Outcome results
Primary
Treatment Efficacy
The primary endpoint of the trial is to the efficacy of using nasal high flow therapy to stabilize breathing, as measured by the breath flow signal from PSG.
Time frame: During 1 night of Sleep on PSG
Population: Out of 6 patient enrolled, 2 withdrew before participating in the study, 1 did not turn up to his appointment. From 3 participants who took part in the study,1 had a positive diagnosis of Cheyne-Stokes Respiration (CSR). The 1 patient who underwent treatment found the device too uncomfortable therefore no outcome measure data were available.