High Flow Nasal Cannula for Obstructive Sleep Apnea

Obstructive Sleep Apnea Clinical Trial

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT03843372
• Other study ID #: 201601844B0
• Status: Completed
• Phase: N/A
• Start date: December 30, 2017
• Est. completion date: March 30, 2020

Study information

• Verified date: November 2020
• Source: Chang Gung Memorial Hospital
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 32
• Est. completion date: March 30, 2020
• Est. primary completion date: December 30, 2019
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

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

Related Conditions & MeSH terms

• Apnea
• Obstructive Sleep Apnea
• Sleep Apnea Syndromes
• Sleep Apnea, Obstructive

Intervention

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.

Locations

Country	Name	City	State
Taiwan	Sleep center	Keelung

Sponsors (1)

Lead Sponsor	Collaborator
Chung-Chieh, Yu

Country where clinical trial is conducted

Taiwan, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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
Primary	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	Total Sleep Time	The total amount of sleep time spent during a study period.	2 days
Secondary	Sleep Efficiency	Sleep efficiency is the percentage of the total time spent asleep compared to the total amount of recording time.	2days