High Flow Nasal Cannula for Obstructive Sleep Apnea

NCT03843372 | Completed Results

• 1 other identifier: 201601844B0
• Study Type: interventional
• Target: 32
• Locations: 1 country
• Sites: 1

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.

Conditions

Obstructive Sleep Apnea

Keywords

Continuous Positive Airway pressure; High Flow Nasal Cannula

Outcome Measures

Primary Outcomes (2)

• 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 Outcomes (2)

• Total Sleep Time

  2 days

• Sleep Efficiency

  2days

Study Arms (2)

First night HFNC group

EXPERIMENTAL

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

First night CPAP group

ACTIVE COMPARATOR

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

Interventions

High flow nasal cannula DEVICE

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

Also known as: continuous positive airway pressure

First night CPAP group; First night HFNC group

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

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

You may not qualify if:

• 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

Sponsors & Collaborators

• Chung-Chieh, Yu: lead

Study Sites (1)

Sleep center

Keelung, 204, Taiwan

Location

Related Publications (1)

• 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.

  PMID: 34145538 DERIVED

MeSH Terms

Conditions

Sleep Apnea, Obstructive

Interventions

Continuous Positive Airway Pressure

Condition Hierarchy (Ancestors)

Sleep Apnea Syndromes; Apnea; Respiration Disorders; Respiratory Tract Diseases; Sleep Disorders, Intrinsic; Dyssomnias; Sleep Wake Disorders; Nervous System Diseases

Intervention Hierarchy (Ancestors)

Positive-Pressure Respiration; Respiration, Artificial; Airway Management; Therapeutics; Respiratory Therapy

Results Point of Contact

• Title: Dr. Chung-Chieh Yu
• Organization: Sleep Center, Chang Gung Memorial Hospital, Keelung, Taiwan

terminatorchieh@yahoo.com.tw

886+22432-9292

Study Officials

• Sleep center

  Chang Gung Memorial Hospital, Keelung

  PRINCIPAL INVESTIGATOR

Publication Agreements

• PI is Sponsor Employee: No
• Restrictive Agreement: No

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: CROSSOVER
• Sponsor Type: OTHER
• Responsible Party: SPONSOR INVESTIGATOR
• PI Title: Director of Sleep Center

Model Details: All of participants will be randomly allocated into two groups as random number table. The first group will ongoing CPAP therapy in first night and high flow nasal cannula in the second night. The second group will oppositely performed high flow nasal cannula in first night and CPAP in second night.

Study Record Dates

• First Submitted: February 9, 2019
• First Posted: February 18, 2019
• Study Start: December 30, 2017
• Primary Completion: December 30, 2019
• Study Completion: March 30, 2020
• Last Updated: December 17, 2020
• Results First Posted: December 17, 2020

Record last verified: 2020-11

Data Sharing

• IPD Sharing: Will share
• Shared Documents: STUDY PROTOCOL, SAP, ICF, CSR, ANALYTIC CODE
• Time Frame: Data will available within 12 months of study completion
• Access Criteria: Requestors need application and explain the purpose. The data access will be provided after approved by review panel.

Locations

TW (1)