Sleep Disordered BreathingNCT02152566
Nasal High Flow Therapy for the Treatment of Respiratory Insufficiencies During Sleep
A study testing Nasal High flow therapy device in people with Sleep Disordered Breathing and Congestive Heart Failure, run by Fisher and Paykel Healthcare at 2 sites in New Zealand.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Sleep Disordered Breathing, Congestive Heart Failure
- What is being tested?
- Nasal High flow therapy device
- Type of treatment
- Medical device
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 6 participants
- Where
- 2 sitesNew Zealand
- Study dates
- Apr 2014to Aug 2014
- Phase
- Interventional
- Are there results?
- Yes, posted in the registrySummary in the doctors' view
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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
Who cannot join
- 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.
Trial locations and contacts
2 sites in 1 country.
New Zealand2 sites
Fisher & Paykel Healthcare Ltd.
Auckland, East Tamaki, 1010
Middlemore Hospital
Auckland, Otahuhu, 2025
About this study
Official title: Study of the Effects of Nasal High Flow Therapy as a Treatment Option for Patients With Respiratory Insufficiencies During Sleep.
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.
- Being tested
- Nasal High flow therapy device
- Medical subject headings
- Sleep Apnea Syndromes, Heart Failure
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Nasal High flow therapy deviceDevice
Nasal high flow therapy via nasal cannula.
| Study group | Role | What they receive |
|---|---|---|
| Diagnostic PSG/PG, PSG w. nasal high flow therapy | Experimental | 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. Receives: Device: Nasal High flow therapy device |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: During 1 night of Sleep on PSG
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted2 Jun 2014 (estimated)
- Study startApr 2014
- Primary completionAug 2014
- Study completionAug 2014
Why it stopped: Difficulty with recruitment
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Posted resultsParticipant flow, outcome measures and adverse events reported by the sponsor.
- Other trials for Sleep Disordered BreathingStudies of the same condition, open and under way.
- More trials run by Fisher and Paykel HealthcareThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Basic science
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 6 participants (actual)
Sponsor and investigators
- Lead sponsor
- Fisher and Paykel Healthcare
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
- Investigators
- Rachel Vicars, PhD - Eng, Principal investigator, Fisher & Paykel Healthcare
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02152566
- Sponsor's protocol ID
- CIA-117
- Status last verified
- Jan 2016
- First submitted
- 29 May 2014
- Last updated
- 8 Feb 2016
- Results posted
- Yes, on ClinicalTrials.gov
- Data monitoring committee
- Yes
Study at a glance
From the registry record, last updated by the sponsor on 8 Feb 2016. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Study of the Effects of Nasal High Flow Therapy as a Treatment Option for Patients With Respiratory Insufficiencies During Sleep.
- ClinicalTrials.gov ID
- NCT02152566
- Acronym / sponsor ID
- CIA-117
- Study type
- Interventional
- Recruitment status
- TerminatedReason stopped: Difficulty with recruitment
- Enrolment
- 6 participants (actual)
- Lead sponsor
- Fisher and Paykel HealthcareIndustry (pharma, biotech, devices)
- Study start
- Apr 2014
- Primary completion
- Aug 2014 (actual)
- Study completion
- Aug 2014 (actual)
- First posted
- 2 Jun 2014 (estimated)
- Results
- Posted 17 Sep 2015
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Basic science
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Diagnostic PSG/PG, PSG w. nasal high flow therapy | Experimental | Device: Nasal High flow therapy deviceAll 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. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (5 listed)
- 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
Key exclusion criteria (8 listed)
- Unstable angina
- Myocardial infarction within the last 12 months
- Cardiac surgery within the previous 6 months
- Pregnancy
- Unwilling or unable to provide informed consent
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Nasal High flow therapy deviceNasal high flow therapy via nasal cannula. | Device | Diagnostic PSG/PG, PSG w. nasal high flow therapy |
Primary outcome
Treatment Efficacy
Time frame: 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.
Results and safety
Loading the posted results from ClinicalTrials.gov…
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 8 Feb 2016.
- Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Rachel Vicars, PhD - Eng principal investigator
Fisher & Paykel Healthcare
2 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Nasal High flow therapy device in people with Sleep Disordered Breathing and Congestive Heart Failure, run by Fisher and Paykel Healthcare at 2 sites in New Zealand.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 5 inclusion and 8 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: stopped early, as of the sponsor's last update on 8 Feb 2016. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 2 sites in New Zealand. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
Yes. Results are posted in the registry (first posted 17 Sep 2015). A summary is in the For doctors view, and the full results are on ClinicalTrials.gov.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Treatment Efficacy (time frame: During 1 night of Sleep on PSG). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 8 Feb 2016.