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Status unknownNCT05549245Updated Sep 22, 2022

Clinical Efficacy of High-flow Nasal Cannula Oxygen Therapy in Patients With Obstructive Sleep Apnea

An interventional study of high-flow nasal cannula oxygen therapy, and CPAP in Obstructive Sleep Apnea, sponsored by Qilu Hospital of Shandong University. Status unknown at 1 site in China. Open to participants aged 18 Years to 70 Years. Per ClinicalTrials.gov, last updated 2022-09-22.

Sponsored by Qilu Hospital of Shandong University · Not applicable, Interventional, and Treatment

The sponsor has not verified this record recently (last verified Aug 2022), so the status shown — last known as Recruiting — may be out of date.
Phase
Not applicable
Study type
Interventional
Enrollment
194
Allocation
Randomized
Ages
18 Years to 70 Years
Sex
All
01

Study summary

Patients meeting the criteria of obstructive sleep apnea were included, and all patients signed informed consent, which met the requirements of the ethics Committee of our unit. All subjects were hospitalized patients. Subjects were randomly enrolled into High-flow Nasal Cannula Oxygen Therapy group or Continues Positive Airway Pressure group for 3 days of treatment. Sleep monitoring was performed on the first and fourth day of enrollment.

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Conditions studied

  • Obstructive Sleep Apnea

Keywords

  • Continues Positive Airway Pressure
  • High-flow Nasal Cannula Oxygen Therapy
03

In context

Apnea

1,422 studies on the registry are indexed under Apnea; 160 are open to participants now.

This study's planned enrollment of 194 is above the median of 51 across 966 interventional studies indexed under Apnea.

Browse Apnea studies →

Lead sponsor

Qilu Hospital of Shandong University is the lead sponsor of 299 studies on the registry; 181 are open to participants now.

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

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Who can participate

Ages eligible
18 Years to 70 Years
Sexes eligible
All
Accepts healthy volunteers
No

Inclusion criteria

  1. There were typical symptoms of sleep snoring at night with apnea and daytime sleepiness (ESS score ≥9). Stenosis and obstruction in any part of the upper airway were observed on physical examination, with AHI≥5 times /h.
  2. For patients with no significant daytime sleepiness (ESS score \< 9), AHI≥10 times /h.
  3. Patients with AHI≥5 times /h had one or more OSAHS complications, such as cognitive impairment, hypertension, coronary heart disease, cerebrovascular disease, diabetes and insomnia.

Exclusion criteria

Exclusion Criteria:

  1. Patients who cannot tolerate non-invasive ventilator or transnasal high-flow oxygen therapy.
  2. Ongoing treatment may affect sleep, such as sedatives, hypnotics, muscle relaxants, etc.
  3. Hemodynamic instability.
  4. Severe respiratory diseases.
05

Study design

Phase
Not applicable
Primary purpose
Treatment
Allocation
Randomized
Intervention model
Parallel assignment
Masking
Single (Outcomes assessor)
Enrollment
194 participants (estimated)

Study arms

  • Experimental
    High-flow Nasal Cannula Oxygen Therapy group

    Device: high-flow nasal cannula oxygen therapy,

  • Other
    Continues Positive Airway Pressure group

    Device: CPAP

Interventions

  • Devicehigh-flow nasal cannula oxygen therapy,

    Patients were treated with high-flow nasal cannula oxygen therapy for three nights

  • DeviceCPAP

    Patients were treated with CPAP for three nights

06

What researchers measure

Primary outcomes

  1. AHI

    Apnea Hypopnea Index:The number of episodes of sleep apnea per hour

    Time frame: The first day of enrollment

  2. AHI

    Apnea Hypopnea Index:The number of episodes of sleep apnea per hour

    Time frame: The fourth day of enrollment

  3. Treatment failure rate

    Number of patients unable to tolerate treatment/enrollment

    Time frame: The fourth day of enrollment

  4. Good compliance rate

    Number of patients treated for more than 4 hours per night/enrolled

    Time frame: The fourth day of enrollment

  5. longest apnea time

    Maximum duration(s) of nocturnal sleep apnea in patients

    Time frame: The first day of enrollment

  6. longest apnea time

    Maximum duration(s) of nocturnal sleep apnea in patients

    Time frame: The fourth day of enrollment

  7. Mean oxygen saturation

    Mean oxygen saturation during the patient's night sleep

    Time frame: The first day of enrollment

  8. Mean oxygen saturation

    Mean oxygen saturation during the patient's night sleep

    Time frame: The fourth day of enrollment

  9. minimum oxygen saturation

    Lowest oxygen saturation during the patient's night sleep

    Time frame: The first day of enrollment

  10. minimum oxygen saturation

    Lowest oxygen saturation during the patient's night sleep

    Time frame: The fourth day of enrollment

Secondary outcomes

  1. Gender

    Male and female

    Time frame: The first day of enrollment

  2. height

    Height (in cm)

    Time frame: The first day of enrollment

  3. age

    years

    Time frame: The first day of enrollment

  4. weight

    Kg

    Time frame: The first day of enrollment

  5. total sleep time

    Total sleep duration(min) of the patient at night

    Time frame: The first day of enrollment

  6. total sleep time

    Total sleep duration(min) of the patient at night

    Time frame: The fourth day of enrollment

  7. Number of awakening

    The number of awakenings during the patient's night sleep

    Time frame: The first day of enrollment

  8. Number of awakening

    The number of awakenings during the patient's night sleep

    Time frame: The fourth day of enrollment

07

Study locations

1 of 1 sites recruiting
  • Qilu Hospital of Shandong University
    Jinan, Shandong 250012, China
    • Dedong Ma, Doctor · Contact · ma@qiluhuxi.com · 18560082806
    • Enqi Zhao, doctor · Contact · zeq@qiluhuxi.com · 15550834269
    • enqi Zhao, doctor · Principal investigator
    Recruiting
08

References and documents

Publications

  • Jordan AS, McSharry DG, Malhotra A. Adult obstructive sleep apnoea. Lancet. 2014 Feb 22;383(9918):736-47. doi: 10.1016/S0140-6736(13)60734-5. Epub 2013 Aug 2. PubMed 23910433 ↗
  • Benjafield AV, Ayas NT, Eastwood PR, Heinzer R, Ip MSM, Morrell MJ, Nunez CM, Patel SR, Penzel T, Pepin JL, Peppard PE, Sinha S, Tufik S, Valentine K, Malhotra A. Estimation of the global prevalence and burden of obstructive sleep apnoea: a literature-based analysis. Lancet Respir Med. 2019 Aug;7(8):687-698. doi: 10.1016/S2213-2600(19)30198-5. Epub 2019 Jul 9. PubMed 31300334 ↗
  • Parke RL, McGuinness SP. Pressures delivered by nasal high flow oxygen during all phases of the respiratory cycle. Respir Care. 2013 Oct;58(10):1621-4. doi: 10.4187/respcare.02358. Epub 2013 Mar 19. PubMed 23513246 ↗
  • Nakanishi N, Suzuki Y, Ishihara M, Ueno Y, Tane N, Tsunano Y, Itagaki T, Oto J. Effect of High-Flow Nasal Cannula on Sleep-disordered Breathing and Sleep Quality in Patients With Acute Stroke. Cureus. 2020 Jul 20;12(7):e9303. doi: 10.7759/cureus.9303. PubMed 32832300 ↗
  • Yan H, Qinghua L, Mengyuan P, Yaoyu C, Long Z, Mengjie L, Xiaosong D, Fang H. High flow nasal cannula therapy for obstructive sleep apnea in adults. Sleep Breath. 2022 Jun;26(2):783-791. doi: 10.1007/s11325-021-02453-6. Epub 2021 Aug 12. PubMed 34383275 ↗
  • Nilius G, Wessendorf T, Maurer J, Stoohs R, Patil SP, Schubert N, Schneider H. Predictors for treating obstructive sleep apnea with an open nasal cannula system (transnasal insufflation). Chest. 2010 Mar;137(3):521-8. doi: 10.1378/chest.09-0357. Epub 2009 Dec 1. PubMed 19952061 ↗

Individual participant data

Plan to share: No

09

Updates

Tracking since Sep 25, 2026
No changes since tracking began. The registry record was last updated on Sep 22, 2022, before this site started recording changes on Sep 25, 2026. Its history is on ClinicalTrials.gov ↗
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Registry details

Key details

Study ID
NCT05549245
Lead sponsor
Qilu Hospital of Shandong University
Responsible party
Sponsor
First posted
Sep 22, 2022
Start date
Aug 20, 2022
Primary completion
May 2023 (estimated)
Completion
May 2023 (estimated)
Last update
Sep 22, 2022

Study contacts

Dedong Ma, doctor
Contact
ma@qiluhuxi.com
18560082806
enqi Zhao, master
principal investigator · Qilu Hospital of Shandong University

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 status unknown, as verified in Aug 2022. You cannot join it, but the record below documents what was studied.

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