Cerebral InfarctionNCT04173767
High-flow Nasal Cannula Oxygen Therapy for Ischemic Stroke Patients With Dysphagia and Obstructive Sleep Apnea
A study testing high flow nasal cannula ventilation in people with Cerebral Infarction and Sleep Apnea, Obstructive, run by Chang Gung Memorial Hospital at 1 site in Taiwan.
Trial summary
High flow nasal cannula (HFNC) ventilation therapy was found to improve the severity of obstructive sleep apnea in non-stroke subjects. The investigators hypothesized that HFNC might be effective in stroke patients with dysphagia who needed nasogastric tube feeding and can not receive continuous positive airway… Read more about this study
- Who is it for?
- Ages 20 years and older
- Conditions the study is for
- Cerebral Infarction, Sleep Apnea, Obstructive, Deglutition Disorders
- What is being tested?
- high flow nasal cannula ventilation
- Type of treatment
- Medical device
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 22 participants
- Where
- 1 siteTaiwan
- Study dates
- 1 Feb 2018to 31 Jan 2019
- 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 20 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- ischemic stroke patients with dysphagia and obstructive sleep apnea who need nasogastric tube feedings
Who cannot join
- congestive heart failure, unconsciousness, chronic obstructive pulmonary disease, intracranial hemorrhage or malignancy, and unstable medical and neurological conditions
- central sleep apnea
Trial locations and contacts
1 site in 1 country.
About this study
High flow nasal cannula (HFNC) ventilation therapy was found to improve the severity of obstructive sleep apnea in non-stroke subjects. The investigators hypothesized that HFNC might be effective in stroke patients with dysphagia who needed nasogastric tube feeding and can not receive continuous positive airway pressure ventilation for obstructive sleep apnea.
- Being tested
- high flow nasal cannula ventilation
- Medical subject headings
- Cerebral Infarction, Sleep Apnea, Obstructive, Deglutition Disorders
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
high flow nasal cannula ventilationDevice
High-flow nasal cannula (HFNC) ventilation therapy: supply heated \& humidified air up to 60 L/min of flow; effects: positive end expiratory pressure effect, humidification.
| Study group | Role | What they receive |
|---|---|---|
| HFNC | Experimental | Not described Receives: Device: high flow nasal cannula ventilation |
What is being measured
The primary outcome is the main question the study is designed to answer.
apnea-hypopnea index
respiratory inductance plethysmography sum (RIPsum) without calibration to score apnea and hypopnea events (American Academy of Sleep Medicine alternative criteria)
Measured: once at polysomnography study night when receive high flow nasal cannula titration study
oxyhemoglobin desaturation index
number of times per hour of sleep that the blood's oxygen saturation level drops by ≥ 3% from baseline
Measured: once at polysomnography study night when receive high flow nasal cannula titration study
Secondary outcomes (2)
pulse wave velocity
velocity (m/s) measured by SphygmoCor CPV system
Measured: baseline and 1 week after high flow nasal cannula therapy
heart rate variability
measured by QHRV system (Medeia Ltd.)
Measured: baseline and 1 week after high flow nasal cannula therapy
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted22 Nov 2019
- Study start1 Feb 2018
- Primary completion31 Jan 2019
- Study completion31 Jan 2019
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Cerebral InfarctionStudies of the same condition, open and under way.
- More trials run by Chang Gung Memorial HospitalThe 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
- Masking
- None (open label)
- Enrolment
- 22 participants (actual)
Sponsor and investigators
- Lead sponsor
- Chang Gung Memorial Hospital
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, CHEN,CHUNG YAO, Chang Gung Memorial Hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04173767
- Sponsor's protocol ID
- CMRPG2H0011
- Status last verified
- Nov 2019
- First submitted
- 19 Nov 2019
- Last updated
- 22 Nov 2019
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 22 Nov 2019. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- High-flow Nasal Cannula Oxygen Therapy for Ischemic Stroke Patients With Dysphagia and Obstructive Sleep Apnea
- ClinicalTrials.gov ID
- NCT04173767
- Acronym / sponsor ID
- CMRPG2H0011
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 22 participants (actual)
- Lead sponsor
- Chang Gung Memorial HospitalUniversity, hospital or other
- Study start
- 1 Feb 2018 (actual)
- Primary completion
- 31 Jan 2019 (actual)
- Study completion
- 31 Jan 2019 (actual)
- First posted
- 22 Nov 2019 (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.
High flow nasal cannula (HFNC) ventilation therapy was found to improve the severity of obstructive sleep apnea in non-stroke subjects. The investigators hypothesized that HFNC might be effective in stroke patients with dysphagia who needed nasogastric tube feeding and can not receive continuous positive airway pressure ventilation for obstructive sleep apnea.
Study design
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| HFNC | Experimental | Device: high flow nasal cannula ventilation |
Who may qualify
- Ages
- 20 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (1 listed)
- ischemic stroke patients with dysphagia and obstructive sleep apnea who need nasogastric tube feedings
Key exclusion criteria (2 listed)
- congestive heart failure, unconsciousness, chronic obstructive pulmonary disease, intracranial hemorrhage or malignancy, and unstable medical and neurological conditions
- central sleep apnea
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 |
|---|---|---|
| high flow nasal cannula ventilationHigh-flow nasal cannula (HFNC) ventilation therapy: supply heated \& humidified air up to 60 L/min of flow; effects: positive end expiratory pressure effect, humidification. | Device | HFNC |
Primary outcome
apnea-hypopnea index
Time frame: once at polysomnography study night when receive high flow nasal cannula titration study
respiratory inductance plethysmography sum (RIPsum) without calibration to score apnea and hypopnea events (American Academy of Sleep Medicine alternative criteria)
oxyhemoglobin desaturation index
Time frame: once at polysomnography study night when receive high flow nasal cannula titration study
number of times per hour of sleep that the blood's oxygen saturation level drops by ≥ 3% from baseline
2 secondary outcomes
pulse wave velocity
Time frame: baseline and 1 week after high flow nasal cannula therapy
heart rate variability
Time frame: baseline and 1 week after high flow nasal cannula therapy
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 22 Nov 2019.
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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.
The record lists no contact. Use the official record to reach the sponsor.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing high flow nasal cannula ventilation in people with Cerebral Infarction and Sleep Apnea, Obstructive, run by Chang Gung Memorial Hospital at 1 site in Taiwan.
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 1 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: finished, as of the sponsor's last update on 22 Nov 2019. 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 Taiwan. 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 is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
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?
apnea-hypopnea index (time frame: once at polysomnography study night when receive high flow nasal cannula titration study). The study lists 2 primary outcomes in all. 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 22 Nov 2019.