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Clinical Trials/NCT04173767
NCT04173767
Completed
Not Applicable

High-flow Nasal Cannula Oxygen Therapy for Ischemic Stroke Patients With Dysphagia and Obstructive Sleep Apnea

Chang Gung Memorial Hospital1 site in 1 country22 target enrollmentFebruary 1, 2018

Overview

Phase
Not Applicable
Intervention
Not specified
Conditions
Cerebral Infarction
Sponsor
Chang Gung Memorial Hospital
Enrollment
22
Locations
1
Primary Endpoint
apnea-hypopnea index
Status
Completed
Last Updated
6 years ago

Overview

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.

Registry
clinicaltrials.gov
Start Date
February 1, 2018
End Date
January 31, 2019
Last Updated
6 years ago
Study Type
Interventional
Study Design
Single Group
Sex
All

Investigators

Sponsor
Chang Gung Memorial Hospital
Responsible Party
Principal Investigator
Principal Investigator

CHEN,CHUNG YAO

Physician, associate professor, department of physical medicine and rehabilitation

Chang Gung Memorial Hospital

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

Outcomes

Primary Outcomes

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

Secondary Outcomes

  • heart rate variability(baseline and 1 week after high flow nasal cannula therapy)
  • pulse wave velocity(baseline and 1 week after high flow nasal cannula therapy)

Study Sites (1)

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