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CompletedNCT03777202Updated Jul 5, 2022

Efficacy of High Flow Nasal Oxygen During Sleep Endoscopy in Patients of Obstructive Sleep Apnea

An interventional study of High-flow nasal oxygen and Low-flow nasal oxygen in Obstructive Sleep Apnea, sponsored by Yonsei University. Completed at 1 site in South Korea. Open to participants aged 19 Years and older. Per ClinicalTrials.gov, last updated 2022-07-05.

Sponsored by Yonsei University · Not applicable, Interventional, and Treatment

Phase
Not applicable
Study type
Interventional
Enrollment
24
Allocation
Randomized
Ages
19 Years and older
Sex
All
01

Study summary

The purpose of this study is to investigate the utility of high-flow nasal oxygen during sleep endoscopy in obstructive sleep apnea patients.

02

Conditions studied

  • Obstructive Sleep Apnea
03

In context

Sleep Apnea, Obstructive

2,263 studies on the registry are indexed under Sleep Apnea, Obstructive; 465 are open to participants now.

This study's enrollment of 24 is below the median of 53 across 1,490 interventional studies indexed under Sleep Apnea, Obstructive.

Browse Sleep Apnea, Obstructive studies →

Lead sponsor

Yonsei University is the lead sponsor of 1,410 studies on the registry; 235 are open to participants now.

Counted across the registry records on this site, refreshed daily.

04

Who can participate

Ages eligible
19 Years and older
Sexes eligible
All
Accepts healthy volunteers
No

Go through the criteria one by one — yes, no or not sure — and take the list to your doctor or the study team. Kept in this browser only.

Inclusion criteria

  • adult patients aged over 19 years who are scheduled for sleep endoscopy

Exclusion criteria

Exclusion Criteria:

  • 1) basal skull fracture, 2) facial anomaly, 3) consciousness disorder, 4) Risk of aspiration, 5) necessity of awake fiberoptic intubation due to the large vocal cord mass, endotracheal tumor or bleeding.
05

Study design

Phase
Not applicable
Primary purpose
Treatment
Allocation
Randomized
Intervention model
Parallel assignment
Masking
None (open label)
Enrollment
24 participants (actual)

Study arms

  • Experimental
    High-flow nasal oxygen during sleep endoscopy

    High-flow nasal oxygen will be applied to the patients through nasal openings using Optiflow system during sleep endoscopy. Pulse oximetry will be monitored continuously. Otorhinolaryngologist will observe the degree of upper airway obstruction during sleep endoscopy.

    Procedure: High-flow nasal oxygen

  • Active comparator
    Low-flow nasal oxygen during sleep endoscopy

    Low-flow nasal oxygen will be applied to the patients through nasal openings using conventional nasal cannula during sleep endoscopy. Pulse oximetry will be monitored continuously. Otorhinolaryngologist will observe the degree of upper airway obstruction during sleep endoscopy.

    Procedure: Low-flow nasal oxygen

Interventions

  • ProcedureHigh-flow nasal oxygen

    High-flow nasal oxygen will be applied to the patients using Optiflow system through nasal openings during sleep endoscopy. Pulse oximetry will be monitored continuously. Otorhinolaryngologist will observe the degree of upper airway obstruction during sleep endoscopy.

  • ProcedureLow-flow nasal oxygen

    Low-flow nasal oxygen will be applied to the patients through nasal openings using conventional nasal cannula during sleep endoscopy. Pulse oximetry will be monitored continuously. Otorhinolaryngologist will observe the degree of upper airway obstruction during sleep endoscopy.

06

What researchers measure

Primary outcomes

  1. oxygen saturation value

    Pulse oximetry will be monitored continuously during sleep endoscopy. Oxygen saturation value will be recorded during the procedure.

    Time frame: For 15 minutes during sleep endoscopy. At Day 0.

07

Study locations

1 site
  • Department of Anesthesiology and Pain Medicine, Anesthesia and Pain Research Institute, Yonsei University College of Medicine
    Seoul, 03722, South Korea
08

Timeline

Tracking since Sep 25, 2026
ElapsedEstimatedEstimated, not yet reachedSimilar studies: half by the dot; the band is the middle halfHalf of similar studies reached it by the dot; the band is the middle half, from a quarter to three quarters

Ran from Jul 2020 to primary completion in Mar 2022, 20 months.

Of 511 non-industry interventional studies with no phase under Sleep Apnea, Obstructive, half reached primary completion within 32 months of starting (the median), counting those still running; a quarter within 16 and three quarters within 53. This study's 20 months is below that.

Counting every sponsor, half of 621 studies reached it within 26 months; a quarter within 12 and three quarters within 50.

How these figures are worked out, and which studies are left out of them.

Registered
Dec 14, 2018
First posted
Dec 17, 2018
StartActual
Jul 17, 2020
Primary completionActual
Mar 25, 2022
CompletionActual
Mar 25, 2022
Last update
Jul 5, 2022
What these dates mean
Start.
When the first participant enrolled; while estimated, when the study expects to open to recruitment.
Primary completion.
When the last participant was examined or treated to collect data for the study's main question, its primary outcome. A study that stopped early gives the date its data collection stopped.
Completion.
When the last participant's last visit took place, for every outcome, secondary ones and side effects included: the end of the study. Often later than primary completion, sometimes the same day.
Actual and Est.
Actual means the registry says the date has happened. Est. (estimated) is a date the sponsor plans or expects. It can still move, and the sponsor is expected to change it to actual once it has passed.
No changes since tracking began. The registry record was last updated on Jul 5, 2022, before this site started recording changes on Sep 25, 2026. Its history is on ClinicalTrials.gov ↗
09

Registry details

Key details

Study ID
NCT03777202
Lead sponsor
Yonsei University
Responsible party
Sponsor
First posted
Dec 17, 2018
Start date
Jul 17, 2020
Primary completion
Mar 25, 2022
Completion
Mar 25, 2022
Last update
Jul 5, 2022

Study contacts

Hyun Joo Kim
principal investigator · Department of Anesthesiology and Pain Medicine, Anesthesia and Pain Research Institute

Oversight

Data monitoring committee
No
FDA-regulated drug
No
FDA-regulated device
No
View the source record on ClinicalTrials.gov ↗

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This study is completed, as verified in Jun 2022. You cannot join it, but the record below documents what was studied.

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