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Completed

NCT Number: NCT04173767

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

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.

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Key information

Conditions

Cerebral Infarction Apnea Brain Diseases Brain Infarction Brain Ischemia Cardiovascular Diseases Central Nervous System Diseases Cerebrovascular Disorders Deglutition Disorders Digestive System Diseases Dyssomnias Esophageal Diseases Gastrointestinal Diseases Infarction Ischemia Necrosis Nervous System Diseases Otorhinolaryngologic Diseases Pathologic Processes Pathological Conditions, Signs and Symptoms Pharyngeal Diseases Respiration Disorders Respiratory Tract Diseases Sleep Apnea Syndromes Sleep Apnea, Obstructive Sleep Disorders, Intrinsic Sleep Wake Disorders Stroke Vascular Diseases

Age range

20 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Chang Gung Memorial Hospital, Keelung

Keelung, Taiwan

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

high flow nasal cannula ventilation

Device

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 outcomes

  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 outcomes

  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.)

Sponsors and collaborators

Lead sponsor

Chang Gung Memorial Hospital

Other

Registry information

Important dates

Study start
2018
Primary completion
2019
Study completion
2019
First posted
Nov 22, 2019
Registry last updated
Nov 22, 2019

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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