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Trial details imported from ClinicalTrials.gov

For full trial details, please see the original record at https://clinicaltrials.gov/show/NCT02152566




Registration number
NCT02152566
Ethics application status
Date submitted
29/05/2014
Date registered
2/06/2014
Date last updated
8/02/2016

Titles & IDs
Public title
Nasal High Flow Therapy for the Treatment of Respiratory Insufficiencies During Sleep
Scientific title
Study of the Effects of Nasal High Flow Therapy as a Treatment Option for Patients With Respiratory Insufficiencies During Sleep.
Secondary ID [1] 0 0
CIA-117
Universal Trial Number (UTN)
Trial acronym
Linked study record

Health condition
Health condition(s) or problem(s) studied:
Sleep Disordered Breathing 0 0
Congestive Heart Failure 0 0
Condition category
Condition code
Respiratory 0 0 0 0
Sleep apnoea
Respiratory 0 0 0 0
Other respiratory disorders / diseases
Cardiovascular 0 0 0 0
Coronary heart disease
Cardiovascular 0 0 0 0
Other cardiovascular diseases
Cardiovascular 0 0 0 0
Diseases of the vasculature and circulation including the lymphatic system

Intervention/exposure
Study type
Interventional
Description of intervention(s) / exposure
Treatment: Devices - Nasal High flow therapy device

Experimental: 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 with Cheyne-Stokes respiration (CSR) 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.


Treatment: Devices: Nasal High flow therapy device
Nasal high flow therapy via nasal cannula.

Intervention code [1] 0 0
Treatment: Devices
Comparator / control treatment
Control group

Outcomes
Primary outcome [1] 0 0
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.
Timepoint [1] 0 0
During 1 night of Sleep on PSG

Eligibility
Key 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
Minimum age
18 Years
Maximum age
No limit
Gender
Both males and females
Can healthy volunteers participate?
No
Key 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.

Study design
Purpose of the study
Basic Science
Allocation to intervention
Procedure for enrolling a subject and allocating the treatment (allocation concealment procedures)
Methods used to generate the sequence in which subjects will be randomised (sequence generation)
Masking / blinding
Open (masking not used)
Who is / are masked / blinded?



Intervention assignment
Single group
Other design features
Phase
Not Applicable
Type of endpoint(s)
Statistical methods / analysis

Recruitment
Recruitment status
Terminated
Data analysis
Reason for early stopping/withdrawal
Other reasons
Date of first participant enrolment
Anticipated
Actual
Date of last participant enrolment
Anticipated
Actual
Date of last data collection
Anticipated
Actual
Sample size
Target
Accrual to date
Final
Recruitment in Australia
Recruitment state(s)
Recruitment outside Australia
Country [1] 0 0
New Zealand
State/province [1] 0 0
East Tamaki
Country [2] 0 0
New Zealand
State/province [2] 0 0
Otahuhu

Funding & Sponsors
Primary sponsor type
Commercial sector/Industry
Name
Fisher and Paykel Healthcare
Address
Country

Ethics approval
Ethics application status

Summary
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.
Trial website
https://clinicaltrials.gov/show/NCT02152566
Trial related presentations / publications
Public notes

Contacts
Principal investigator
Name 0 0
Rachel Vicars, PhD - Eng
Address 0 0
Fisher & Paykel Healthcare
Country 0 0
Phone 0 0
Fax 0 0
Email 0 0
Contact person for public queries
Name 0 0
Address 0 0
Country 0 0
Phone 0 0
Fax 0 0
Email 0 0
Contact person for scientific queries

Summary results
For IPD and results data, please see https://clinicaltrials.gov/show/NCT02152566