Back to resultsHigh-flow Nasal Cannula Oxygen Therapy for Ischemic Stroke Patients With Dysphagia and Obstructive Sleep Apnea
Primary Purpose
Cerebral Infarction, Sleep Apnea, Obstructive, Deglutition Disorders
Status
Completed
Phase
Not Applicable
Locations
Taiwan
Study Type
Interventional
Intervention
high flow nasal cannula ventilation
Sponsored by
About this trial
This is an interventional treatment trial for Cerebral Infarction
Eligibility Criteria
Inclusion Criteria:
- ischemic stroke patients with dysphagia and obstructive sleep apnea who need nasogastric tube feedings
Exclusion Criteria:
- congestive heart failure, unconsciousness, chronic obstructive pulmonary disease, intracranial hemorrhage or malignancy, and unstable medical and neurological conditions
- central sleep apnea
Sites / Locations
- Chang Gung Memorial Hospital, Keelung
Arms of the Study
Arm 1
Arm Type
Experimental
Arm Label
HFNC
Arm Description
Outcomes
Primary Outcome Measures
apnea-hypopnea index
respiratory inductance plethysmography sum (RIPsum) without calibration to score apnea and hypopnea events (American Academy of Sleep Medicine alternative criteria)
oxyhemoglobin desaturation index
number of times per hour of sleep that the blood's oxygen saturation level drops by ≥ 3% from baseline
Secondary Outcome Measures
pulse wave velocity
velocity (m/s) measured by SphygmoCor CPV system
heart rate variability
measured by QHRV system (Medeia Ltd.)
Full Information
NCT ID
NCT04173767
First Posted
November 19, 2019
Last Updated
November 21, 2019
Sponsor
Chang Gung Memorial Hospital
1. Study Identification
Unique Protocol Identification Number
NCT04173767
Brief Title
High-flow Nasal Cannula Oxygen Therapy for Ischemic Stroke Patients With Dysphagia and Obstructive Sleep Apnea
Official Title
High-flow Nasal Cannula Oxygen Therapy for Ischemic Stroke Patients With Dysphagia and Obstructive Sleep Apnea
Study Type
Interventional
2. Study Status
Record Verification Date
November 2019
Overall Recruitment Status
Completed
Study Start Date
February 1, 2018 (Actual)
Primary Completion Date
January 31, 2019 (Actual)
Study Completion Date
January 31, 2019 (Actual)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Chang Gung Memorial Hospital
4. Oversight
Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
No
5. Study Description
Brief 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 pressure ventilation for obstructive sleep apnea.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Cerebral Infarction, Sleep Apnea, Obstructive, Deglutition Disorders
7. Study Design
Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Single Group Assignment
Masking
None (Open Label)
Allocation
N/A
Enrollment
22 (Actual)
8. Arms, Groups, and Interventions
Arm Title
HFNC
Arm Type
Experimental
Intervention Type
Device
Intervention Name(s)
high flow nasal cannula ventilation
Intervention Description
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.
Primary Outcome Measure Information:
Title
apnea-hypopnea index
Description
respiratory inductance plethysmography sum (RIPsum) without calibration to score apnea and hypopnea events (American Academy of Sleep Medicine alternative criteria)
Time Frame
once at polysomnography study night when receive high flow nasal cannula titration study
Title
oxyhemoglobin desaturation index
Description
number of times per hour of sleep that the blood's oxygen saturation level drops by ≥ 3% from baseline
Time Frame
once at polysomnography study night when receive high flow nasal cannula titration study
Secondary Outcome Measure Information:
Title
pulse wave velocity
Description
velocity (m/s) measured by SphygmoCor CPV system
Time Frame
baseline and 1 week after high flow nasal cannula therapy
Title
heart rate variability
Description
measured by QHRV system (Medeia Ltd.)
Time Frame
baseline and 1 week after high flow nasal cannula therapy
10. Eligibility
Sex
All
Minimum Age & Unit of Time
20 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria:
ischemic stroke patients with dysphagia and obstructive sleep apnea who need nasogastric tube feedings
Exclusion Criteria:
congestive heart failure, unconsciousness, chronic obstructive pulmonary disease, intracranial hemorrhage or malignancy, and unstable medical and neurological conditions
central sleep apnea
Facility Information:
Facility Name
Chang Gung Memorial Hospital, Keelung
City
Keelung
Country
Taiwan
12. IPD Sharing Statement
Learn more about this trial
High-flow Nasal Cannula Oxygen Therapy for Ischemic Stroke Patients With Dysphagia and Obstructive Sleep Apnea
We'll reach out to this number within 24 hrs