High Flow Nasal Cannula for Obstructive Sleep Apnea

NCT ID: NCT03843372

Last Updated: 2020-12-17

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: NA
• Total Enrollment: 32 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2017-12-30
• Study Completion Date: 2020-03-30

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.

Conditions

Obstructive Sleep Apnea

Keywords

Continuous Positive Airway pressure; High Flow Nasal Cannula

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: CROSSOVER
• Primary Study Purpose: TREATMENT
• Blinding Strategy: NONE

Study Groups

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.

Group Type: EXPERIMENTAL

High flow nasal cannula

Intervention Type: DEVICE

All of participants will be received one night high flow nasal cannula and another night for continuous positive airway pressure.

First night CPAP group

In contrast, the first night will receive continuous positive airway pressure and the second accept high flow nasal cannula therapy.

Group Type: ACTIVE_COMPARATOR

High flow nasal cannula

Intervention Type: DEVICE

All of participants will be received one night high flow nasal cannula and another night for continuous positive airway pressure.

Interventions

High flow nasal cannula

All of participants will be received one night high flow nasal cannula and another night for continuous positive airway pressure.

Intervention Type: DEVICE

Other Intervention Names

continuous positive airway pressure

Eligibility Criteria

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

• Minimum Eligible Age: 18 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Chung-Chieh, Yu

OTHER

Sponsor Role: lead

Responsible Party

Chung-Chieh, Yu

Director of Sleep Center

Responsibility Role: SPONSOR_INVESTIGATOR

Principal Investigators

Sleep center

Role: PRINCIPAL_INVESTIGATOR

Chang Gung Memorial Hospital, Keelung

Locations

Sleep center

Keelung, , Taiwan

Countries

Taiwan

References

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.

Reference Type: DERIVED

PMID: 34145538 (View on PubMed)

Provided Documents

Document Type: Study Protocol and Statistical Analysis Plan

View Document

Other Identifiers

201601844B0

Identifier Type: -

Identifier Source: org_study_id