Central Sleep ApneaRELAXNCT03085641
Treatment of Central Sleep Apnoea in Patients With Heart Failure With Nasal High Flow Therapy (nHFT)
A study testing Nasal high flow oxygen therapy in people with Central Sleep Apnea and Cheyne-Stokes Respiration, run by University Medical Center Groningen at 1 site in Netherlands.
Trial summary
To investigate whether nHFT is an effective treatment for patients with Chronic Heart Failure (CHF) and central sleep apnea (CSA). This study is a prospective one armed uncontrolled intervention pilot study investigating 4 weeks of nHFT at home in 10 patients with CHF and CSA. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Central Sleep Apnea, Cheyne-Stokes Respiration
- What is being tested?
- Nasal high flow oxygen therapy
- Type of treatment
- Medical device
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 6 participants
- Where
- 1 siteNetherlands
- Study dates
- 15 Jun 2017to 18 Oct 2018
- Phase
- Interventional
- Are there results?
- None posted in the registry
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
- Moderate to severe CSA/CSR (AHI>15), in which CSA is defined when at least 50% of the apnoeas are central apnoeas
- Heart failure with reduced ejection fraction, defined as a LVEF < 45% of predicted
Who cannot join
- Other diseases affecting respiration during sleep (COPD GOLD 3 or 4, neuromuscular disorders, thorax cage deformities)
- At the moment of the inclusion, the patient does not have a therapy to treat the CSA, such as continuous positive airway pressure (CPAP), oxygen, bilevel intermittent positive airway pressure (BiPAP) or acetazolamide.
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Treatment of Central Sleep Apnoea and Cheyne Stokes Respiration in Patients With Heart Failure: Nasal High-flow Oxygen Therapy?
To investigate whether nHFT is an effective treatment for patients with Chronic Heart Failure (CHF) and central sleep apnea (CSA).
This study is a prospective one armed uncontrolled intervention pilot study investigating 4 weeks of nHFT at home in 10 patients with CHF and CSA.
Read the detailed description
Study population: 10 CHF patients with a Left Ventricular Injection Fraction(LVEF)< 45% and CSA/Cheyne Stokes Respiration (CSR) (apnoea/hypopnea index (AHI) > 15/hour); with at least 50% of the total number of events having a central character will be included. Patients with other diseases that will influence the respiratory system negatively during sleep i.e. chronic obstructive pulmonary disease (COPD Global Initiative of Obstructive Lung Diseases (GOLD) class 3 and 4), neuromuscular diseases and thorax cage deformities, as well as patients with CHF and CSA that use another form of treatment for their CSA at the time of inclusion, will be excluded.
Intervention: nHFT will be titrated during a first titration night and used at home during the night for 4 weeks consecutively.
Main study parameters/endpoints:
- To investigate the effect of nHFT with and without oxygen in reducing the apnoea/hypopnoea index during sleep after 4 weeks use nHFT.
- To investigate improvements in oxygen desaturation index, sleep quality and sleepiness, physical condition, left ventricular ejection fraction (LVEF), heart beat variability (HRV), N-terminal natriuretic peptide (NTproBNP) after 4 weeks use nHFT .
- Physiological condition; work of breathing and respiratory drive and measuring mouth-throat pressure.
- Conditions
- Central Sleep Apnea, Cheyne-Stokes Respiration
- Being tested
- Nasal high flow oxygen therapy
- Keywords
- High flow oxygen therapy
- Medical subject headings
- Sleep Apnea, Central, Cheyne-Stokes Respiration
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Nasal high flow oxygen therapyDevice
nHFT will be titrated during a first titration night and used at home during the night for 4 weeks consecutively
| Study group | Role | What they receive |
|---|---|---|
| Nasal high flow oxygen therapy | Experimental | The patient is hospitalized for one night.
Initially patients will start with a flow rate of 10 L/min and when they are asleep during the night 90-minute periods of the following settings will be performed:
* Moderate flow rate: 20 L/min without additional oxygen (with room air, which means a fractional inspired oxygen (FiO2) of 21%)
* High flow rate: 40-50 L/min without additional oxygen
* Moderate flow rate: 20 L/min with FiO2 of 28% (comparable to the 2 L/min additional oxygen through a nasal cannula)
* High flow rate: 40-50 L/min with FiO2 of 28% Receives: Device: Nasal high flow oxygen therapy |
What is being measured
The primary outcome is the main question the study is designed to answer.
Reduction of apnea/hypopnea index
the change/reduction in AHI after 4 weeks of treatment with nHFT.
Measured: Baseline, 4 weeks
Secondary outcomes (10)
Improvement physical condition
Exercise tolerance assessed with the 6-minute walking test
Measured: Baseline, 4 weeks
Work of breathing
Transdiaphragmatic pressure as a marker of diaphragmatic true work of breathing, measured with the use of oesophageal and gastric balloon catheters
Measured: Baseline titration night
Drive to breath
Drive to breath assessed with surface electromyography (EMG) of the respiratory muscles
Measured: Baseline titration night, 4 weeks
Sleep latency
Assessed as the the length of time that it takes to accomplish the transition from full wakefulness to sleep, measured by means of electro-encephalogram (ECG) as part of the polysomnography
Measured: Baseline, 4 weeks
Cardiac functioning
Left ventricular injection fraction (LVEF),
Measured: Baseline, 4 weeks
change in oxygen desaturation index (ODI) during sleep while on nHFT
measured after 4 weeks of home nHFT treatment, as compared to the baseline ODI during spontaneous nocturnal breathing.
Measured: Baseline, 4 weeks
Sleep efficiency
The percentage of total time in bed actually spent in sleep, assessed with polysomnography
Measured: Baseline, 4 weeks
Total rapid-eye movement (REM) stage sleep cycles recorded
Assessed with polysomnography
Measured: Baseline, 4 weeks
Heart rate variability
Heart rate variability will be assessed by 24-uur ECG recordings
Measured: Baseline, 4 weeks
N-terminal natriuretic peptide (NTproBNP)
Assessed in venous blood
Measured: Baseline, 4 weeks
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted21 Mar 2017
- Study start15 Jun 2017
- Primary completion18 Oct 2018
- Study completion18 Oct 2018
Why it stopped: Side effects
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Central Sleep ApneaStudies of the same condition, open and under way.
- More trials run by University Medical Center GroningenThe 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
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Model description
- prospective one armed uncontrolled intervention pilot study
- Masking
- None (open label)
- Enrolment
- 6 participants (actual)
Sponsor and investigators
- Lead sponsor
- University Medical Center Groningen
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Marieke Duiverman, University Medical Center Groningen
- Investigators
- Marieke Duiverman, Study director, University Medical Center Groningen
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03085641
- Sponsor's protocol ID
- 201700147
- Acronym
- RELAX
- Status last verified
- Dec 2018
- First submitted
- 8 Mar 2017
- Last updated
- 17 Dec 2018
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 17 Dec 2018. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Treatment of Central Sleep Apnoea and Cheyne Stokes Respiration in Patients With Heart Failure: Nasal High-flow Oxygen Therapy?
- ClinicalTrials.gov ID
- NCT03085641
- Acronym / sponsor ID
- RELAX / 201700147
- Conditions
- Central Sleep Apnea, Cheyne-Stokes Respiration
- Keywords
- High flow oxygen therapy
- Study type
- Interventional
- Recruitment status
- TerminatedReason stopped: Side effects
- Enrolment
- 6 participants (actual)
- Lead sponsor
- University Medical Center GroningenUniversity, hospital or other
- Study start
- 15 Jun 2017 (actual)
- Primary completion
- 18 Oct 2018 (actual)
- Study completion
- 18 Oct 2018 (actual)
- First posted
- 21 Mar 2017 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
To investigate whether nHFT is an effective treatment for patients with Chronic Heart Failure (CHF) and central sleep apnea (CSA).
This study is a prospective one armed uncontrolled intervention pilot study investigating 4 weeks of nHFT at home in 10 patients with CHF and CSA.
Detailed description
Study population: 10 CHF patients with a Left Ventricular Injection Fraction(LVEF)< 45% and CSA/Cheyne Stokes Respiration (CSR) (apnoea/hypopnea index (AHI) > 15/hour); with at least 50% of the total number of events having a central character will be included. Patients with other diseases that will influence the respiratory system negatively during sleep i.e. chronic obstructive pulmonary disease (COPD Global Initiative of Obstructive Lung Diseases (GOLD) class 3 and 4), neuromuscular diseases and thorax cage deformities, as well as patients with CHF and CSA that use another form of treatment for their CSA at the time of inclusion, will be excluded.
Intervention: nHFT will be titrated during a first titration night and used at home during the night for 4 weeks consecutively.
Main study parameters/endpoints:
- To investigate the effect of nHFT with and without oxygen in reducing the apnoea/hypopnoea index during sleep after 4 weeks use nHFT.
- To investigate improvements in oxygen desaturation index, sleep quality and sleepiness, physical condition, left ventricular ejection fraction (LVEF), heart beat variability (HRV), N-terminal natriuretic peptide (NTproBNP) after 4 weeks use nHFT .
- Physiological condition; work of breathing and respiratory drive and measuring mouth-throat pressure.
Study design
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
- Model description
- prospective one armed uncontrolled intervention pilot study
| Arm | Type | Receives |
|---|---|---|
| Nasal high flow oxygen therapy | Experimental | Device: Nasal high flow oxygen therapyThe patient is hospitalized for one night. Initially patients will start with a flow rate of 10 L/min and when they are asleep during the night 90-minute periods of the following settings will be performed: * Moderate flow rate: 20 L/min without additional oxygen (with room air, which means a fractional inspired oxygen (FiO2) of 21%) * High flow rate: 40-50 L/min without additional oxygen * Moderate flow rate: 20 L/min with FiO2 of 28% (comparable to the 2 L/min additional oxygen through a nasal cannula) * High flow rate: 40-50 L/min with FiO2 of 28% |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (2 listed)
- Moderate to severe CSA/CSR (AHI>15), in which CSA is defined when at least 50% of the apnoeas are central apnoeas
- Heart failure with reduced ejection fraction, defined as a LVEF < 45% of predicted
Key exclusion criteria (2 listed)
- Other diseases affecting respiration during sleep (COPD GOLD 3 or 4, neuromuscular disorders, thorax cage deformities)
- At the moment of the inclusion, the patient does not have a therapy to treat the CSA, such as continuous positive airway pressure (CPAP), oxygen, bilevel intermittent positive airway pressure (BiPAP) or acetazolamide.
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 oxygen therapynHFT will be titrated during a first titration night and used at home during the night for 4 weeks consecutively | Device | Nasal high flow oxygen therapy |
Primary outcome
Reduction of apnea/hypopnea index
Time frame: Baseline, 4 weeks
the change/reduction in AHI after 4 weeks of treatment with nHFT.
10 secondary outcomes
Improvement physical condition
Time frame: Baseline, 4 weeks
Work of breathing
Time frame: Baseline titration night
Drive to breath
Time frame: Baseline titration night, 4 weeks
Sleep latency
Time frame: Baseline, 4 weeks
Cardiac functioning
Time frame: Baseline, 4 weeks
change in oxygen desaturation index (ODI) during sleep while on nHFT
Time frame: Baseline, 4 weeks
Sleep efficiency
Time frame: Baseline, 4 weeks
Total rapid-eye movement (REM) stage sleep cycles recorded
Time frame: Baseline, 4 weeks
Heart rate variability
Time frame: Baseline, 4 weeks
N-terminal natriuretic peptide (NTproBNP)
Time frame: Baseline, 4 weeks
Results and safety
The study was stopped early (reason given: Side effects). Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 17 Dec 2018.
- Individual participant dataSharing planned: No
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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.
Marieke Duiverman study director
University Medical Center Groningen
1 site 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 oxygen therapy in people with Central Sleep Apnea and Cheyne-Stokes Respiration, run by University Medical Center Groningen at 1 site in Netherlands.
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 2 inclusion and 2 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 17 Dec 2018. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Netherlands. 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?
The study was stopped early (reason given: Side effects). Results are not available in the source record.
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?
Reduction of apnea/hypopnea index (time frame: Baseline, 4 weeks). 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 17 Dec 2018.