High Flow Nasal Cannula for Obstructive Sleep Apnea

Not Applicable

Completed

• Conditions: Obstructive Sleep Apnea
• Interventions: Device: High flow nasal cannula

• Registration Number: NCT03843372
• Lead Sponsor: Chung-Chieh, Yu

Brief Summary

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.

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 Timeline

• Study Start: 2017-12-30
• Study First Submitted: 2019-02-09
• Study First Submitted QC: 2019-02-14
• Study First Posted: 2019-02-18
• Primary Completion: 2019-12-30
• Study Completion: 2020-03-30
• Results First Submitted: 2020-08-03
• Status Verified: 2020-11
• Results First Submitted QC: 2020-11-22
• Last Update Submitted: 2020-11-22
• Results First Posted: 2020-12-17
• Last Update Posted: 2020-12-17

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 32

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 & Design

• Study Type: INTERVENTIONAL
• Study Design: CROSSOVER

Arm && Interventions

Group	Intervention	Description
First night HFNC group	High flow nasal cannula	The first night will receive high flow nasal cannula (HFNC) therapy and the second night accept continuous positive airway pressure (CPAP) therapy.
First night CPAP group	High flow nasal cannula	In contrast, the first night will receive continuous positive airway pressure and the second accept high flow nasal cannula therapy.

Primary Outcome Measures

Name	Time	Method
Apnea Hypopnea Index	2 days	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.
Oxygen Desaturation Index	2 days	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.

Secondary Outcome Measures

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

Trial Locations

Locations (1)

Sleep center; 🇨🇳 Keelung, Taiwan