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Completed

NCT Number: NCT03843372

High Flow Nasal Cannula for 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.

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Key information

Age range

18 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Sleep center

Keelung, 204, Taiwan

About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

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.

Other names: continuous positive airway pressure

Primary outcomes

  1. Apnea Hypopnea Index

    Time frame: 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.

  2. Oxygen Desaturation Index

    Time frame: 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 outcomes

  1. Total Sleep Time

    Time frame: 2 days

    The total amount of sleep time spent during a study period.

  2. Sleep Efficiency

    Time frame: 2days

    Sleep efficiency is the percentage of the total time spent asleep compared to the total amount of recording time.

Sponsors and collaborators

Lead sponsor

Chung-Chieh, Yu

Other

Registry information

Official study title

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

Important dates

Study start
2017
Primary completion
2019
Study completion
2020
First posted
Feb 18, 2019
Registry last updated
Dec 17, 2020

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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