High Flow Nasal Cannula for Obstructive Sleep Apnea

High Flow Nasal Cannula Compared to Continuous Positive Airway Pressure in the Treatment of Obstructive Sleep Apnea

This study compare the efficacy of high flow nasal cannula with nasal continuous positive airway pressure. All of participants will be randomized to receive one night high flow nasal cannula therapy and another night for nasal continuous positive airway pressure.

Study Overview

• Status: Completed
• Conditions: Obstructive Sleep Apnea
• Intervention / Treatment: Device: High flow nasal cannula

Detailed Description

Obstructive sleep apnea-hypopnea syndrome (OSAHS) is a common medical condition. Nasal continuous positive airway pressure (CPAP) is mainstay of treatment for OSAHS, but CPAP has some limitations. Patient who has bulbar dysfunction and poor consciousness are contraindications for CPAP. They are also not suitable for other therapy. There are still large number of patients could not accept CPAP. Alternative treatment method transnasal high flow was developed and previous study showed moderately reduce respiratory event. It is deliver 20 L/minute constant room air by nasal cannula. Because the technical limitation, the maximal flow rate is also 20 L/minute and it limit the effectiveness.

Recently, new high flow nasal cannula(HFNC) is developed. This HFNC has already widely been used for respiratory disease. It can deliver air flow up to 60 L/mins. It is also can maintain high humidifier and adequate temperature. The every 10 L/min air flow could generate approximately 1 cmH2O positive end expiratory pressure (PEEP). The higher air flow could generate more high PEEP and may have better effect than previous HFNC, but there are no study to evaluate the efficacy in OSAHS patient. Thus, the purpose of our study is to compare the efficacy of HFNC with standard CPAP therapy.

All of the participants were randomized into two groups for minimized first night effects. All of them would receive one-night HFNC therapy and another night for CPAP titration under PSG monitoring. The duration between these two treatments was approximately one week apart. The first group underwent CPAP titration on the first night and HFNC titration on the second night. Conversely, the second group was subjected to HFNC on the first night and CPAP titration on the second night. All of the participants were asked and recorded their side effects following completion of an HFNC or CPAP.

• Study Type: Interventional
• Enrollment (Actual): 32
• Phase: Not Applicable

Contacts and Locations

Study Locations

• Taiwan
  • Keelung, Taiwan, 204
    • Sleep center

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years and older (ADULT, OLDER_ADULT)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

Inclusion Criteria:

• Apnea hypopnea index greater than 5 times per hour
• Age greater than 18 years old.

Exclusion Criteria:

• Central sleep apnea
• Hypoventilation syndrome
• Chronic obstructive airway disease
• Receive soft palate surgery or used an oral appliance
• Intolerance to transnasal high flow or CPAP
• Pregnant women
• Unstable hemodynamic state
• Eastern Cooperative Oncology Group Performance Status higher than grade 2

Study Plan

How is the study designed?

Design Details

• Primary Purpose: TREATMENT
• Allocation: RANDOMIZED
• Interventional Model: CROSSOVER
• Masking: NONE

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
EXPERIMENTAL: First night HFNC group; The first night will receive high flow nasal cannula (HFNC) therapy and the second night accept continuous positive airway pressure (CPAP) therapy.	Device: High flow nasal cannula; All of participants will be received one night high flow nasal cannula and another night for continuous positive airway pressure.; Other Names: continuous positive airway pressure
ACTIVE_COMPARATOR: First night CPAP group; In contrast, the first night will receive continuous positive airway pressure and the second accept high flow nasal cannula therapy.	Device: High flow nasal cannula; All of participants will be received one night high flow nasal cannula and another night for continuous positive airway pressure.; Other Names: continuous positive airway pressure

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Apnea Hypopnea Index	The Apnea Hypopnea Index(AHI) is an index used to indicate the severity of sleep apnea. It is represented by the number of apnea and hypopnea events per hour of sleep. The AHI under one night transnasal high flow therapy will be compared with one night continuous positive airway pressure.	2 days
Oxygen Desaturation Index	The oxygen desaturation index (ODI) is the number of times per hour of sleep that the blood's oxygen level drop by 3% degree from baseline.The ODI under one night transnasal high flow therapy will be compared with one night continuous positive airway pressure.	2 days

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Total Sleep Time	The total amount of sleep time spent during a study period.	2 days
Sleep Efficiency	Sleep efficiency is the percentage of the total time spent asleep compared to the total amount of recording time.	2days

Collaborators and Investigators

• Sponsor: Chung-Chieh, Yu

Publications and helpful links

General Publications

• Yu CC, Huang CY, Hua CC, Wu HP. High-flow nasal cannula compared with continuous positive airway pressure in the treatment of obstructive sleep apnea. Sleep Breath. 2022 Jun;26(2):549-558. doi: 10.1007/s11325-021-02413-0. Epub 2021 Jun 18.

Study record dates

Study Major Dates

• Study Start (ACTUAL): December 30, 2017
• Primary Completion (ACTUAL): December 30, 2019
• Study Completion (ACTUAL): March 30, 2020

Study Registration Dates

• First Submitted: February 9, 2019
• First Submitted That Met QC Criteria: February 14, 2019
• First Posted (ACTUAL): February 18, 2019

Study Record Updates

• Last Update Posted (ACTUAL): December 17, 2020
• Last Update Submitted That Met QC Criteria: November 22, 2020
• Last Verified: November 1, 2020

More Information

Terms related to this study

• Keywords: High Flow Nasal Cannula; Continuous Positive Airway pressure
• Additional Relevant MeSH Terms: Nervous System Diseases; Respiratory Tract Diseases; Respiration Disorders; Sleep Disorders, Intrinsic; Dyssomnias; Sleep Wake Disorders; Signs and Symptoms, Respiratory; Sleep Apnea Syndromes; Sleep Apnea, Obstructive; Apnea
• Other Study ID Numbers: 201601844B0

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: YES
• IPD Plan Description: De-identified participants raw data will be made available.
• IPD Sharing Time Frame: Data will available within 12 months of study completion
• IPD Sharing Access Criteria: Requestors need application and explain the purpose. The data access will be provided after approved by review panel.
• IPD Sharing Supporting Information Type: STUDY_PROTOCOL; SAP; ICF; ANALYTIC_CODE; CSR

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No