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

Not Applicable

Completed

• Conditions: Cerebral Infarction; Deglutition Disorders; Sleep Apnea, Obstructive
• Interventions: Device: high flow nasal cannula ventilation

• Registration Number: NCT04173767
• Lead Sponsor: 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.

Detailed Description

Not available

Study Timeline

• Study Start: 2018-02-01
• Primary Completion: 2019-01-31
• Study Completion: 2019-01-31
• Status Verified: 2019-11
• Study First Submitted: 2019-11-19
• Study First Submitted QC: 2019-11-21
• Last Update Submitted: 2019-11-21
• Study First Posted: 2019-11-22
• Last Update Posted: 2019-11-22

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 22

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

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: SINGLE_GROUP

Arm && Interventions

Group	Intervention	Description
HFNC	high flow nasal cannula ventilation	-

Primary Outcome Measures

Name	Time	Method
apnea-hypopnea index	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	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

Name	Time	Method
heart rate variability	baseline and 1 week after high flow nasal cannula therapy	measured by QHRV system (Medeia Ltd.)
pulse wave velocity	baseline and 1 week after high flow nasal cannula therapy	velocity (m/s) measured by SphygmoCor CPV system

Trial Locations

Locations (1)

Chang Gung Memorial Hospital, Keelung; 🇨🇳 Keelung, Taiwan