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

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT04173767
Recruitment Status : Completed
First Posted : November 22, 2019
Last Update Posted : November 22, 2019
Sponsor:
Information provided by (Responsible Party):
CHEN,CHUNG YAO, Chang Gung Memorial Hospital

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.

Condition or disease Intervention/treatment Phase
Cerebral Infarction Sleep Apnea, Obstructive Deglutition Disorders Device: high flow nasal cannula ventilation Not Applicable

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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 22 participants
Intervention Model: Single Group Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Official Title: High-flow Nasal Cannula Oxygen Therapy for Ischemic Stroke Patients With Dysphagia and Obstructive Sleep Apnea
Actual Study Start Date : February 1, 2018
Actual Primary Completion Date : January 31, 2019
Actual Study Completion Date : January 31, 2019

Resource links provided by the National Library of Medicine


Arm Intervention/treatment
Experimental: HFNC Device: high flow nasal cannula ventilation
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 Measures :
  1. 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)

  2. 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 Outcome Measures :
  1. pulse wave velocity [ Time Frame: baseline and 1 week after high flow nasal cannula therapy ]
    velocity (m/s) measured by SphygmoCor CPV system

  2. heart rate variability [ Time Frame: baseline and 1 week after high flow nasal cannula therapy ]
    measured by QHRV system (Medeia Ltd.)



Information from the National Library of Medicine

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Ages Eligible for Study:   20 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT04173767


Locations
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Taiwan
Chang Gung Memorial Hospital, Keelung
Keelung, Taiwan
Sponsors and Collaborators
Chang Gung Memorial Hospital

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Responsible Party: CHEN,CHUNG YAO, Physician, associate professor, department of physical medicine and rehabilitation, Chang Gung Memorial Hospital
ClinicalTrials.gov Identifier: NCT04173767    
Other Study ID Numbers: CMRPG2H0011
First Posted: November 22, 2019    Key Record Dates
Last Update Posted: November 22, 2019
Last Verified: November 2019

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
Additional relevant MeSH terms:
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Deglutition Disorders
Apnea
Sleep Apnea Syndromes
Sleep Apnea, Obstructive
Cerebral Infarction
Infarction
Respiration Disorders
Respiratory Tract Diseases
Signs and Symptoms, Respiratory
Signs and Symptoms
Ischemia
Pathologic Processes
Necrosis
Sleep Disorders, Intrinsic
Dyssomnias
Sleep Wake Disorders
Nervous System Diseases
Esophageal Diseases
Gastrointestinal Diseases
Digestive System Diseases
Pharyngeal Diseases
Otorhinolaryngologic Diseases
Brain Infarction
Brain Ischemia
Cerebrovascular Disorders
Brain Diseases
Central Nervous System Diseases
Stroke
Vascular Diseases
Cardiovascular Diseases