NCT05549245

Brief 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.

Trial Health

43
At Risk

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Trial has exceeded expected completion date
Enrollment
194

participants targeted

Target at P75+ for not_applicable

Timeline
Completed

Started Aug 2022

Shorter than P25 for not_applicable

Geographic Reach
1 country

1 active site

Status
unknown

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

August 14, 2022

Completed
6 days until next milestone

Study Start

First participant enrolled

August 20, 2022

Completed
1 month until next milestone

First Posted

Study publicly available on registry

September 22, 2022

Completed
7 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

May 1, 2023

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

May 1, 2023

Completed
Last Updated

September 22, 2022

Status Verified

August 1, 2022

Enrollment Period

8 months

First QC Date

August 14, 2022

Last Update Submit

September 19, 2022

Conditions

Obstructive Sleep Apnea

Keywords

Continues Positive Airway PressureHigh-flow Nasal Cannula Oxygen Therapy

Outcome Measures

Primary Outcomes (10)

  • AHI

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

    The first day of enrollment

  • AHI

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

    The fourth day of enrollment

  • Treatment failure rate

    Number of patients unable to tolerate treatment/enrollment

    The fourth day of enrollment

  • Good compliance rate

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

    The fourth day of enrollment

  • longest apnea time

    Maximum duration(s) of nocturnal sleep apnea in patients

    The first day of enrollment

  • longest apnea time

    Maximum duration(s) of nocturnal sleep apnea in patients

    The fourth day of enrollment

  • Mean oxygen saturation

    Mean oxygen saturation during the patient's night sleep

    The first day of enrollment

  • Mean oxygen saturation

    Mean oxygen saturation during the patient's night sleep

    The fourth day of enrollment

  • minimum oxygen saturation

    Lowest oxygen saturation during the patient's night sleep

    The first day of enrollment

  • minimum oxygen saturation

    Lowest oxygen saturation during the patient's night sleep

    The fourth day of enrollment

Secondary Outcomes (8)

  • Gender

    The first day of enrollment

  • height

    The first day of enrollment

  • age

    The first day of enrollment

  • weight

    The first day of enrollment

  • total sleep time

    The first day of enrollment

  • +3 more secondary outcomes

Study Arms (2)

High-flow Nasal Cannula Oxygen Therapy group

EXPERIMENTAL
Device: high-flow nasal cannula oxygen therapy,

Continues Positive Airway Pressure group

OTHER
Device: CPAP

Interventions

high-flow nasal cannula oxygen therapy,DEVICE

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

High-flow Nasal Cannula Oxygen Therapy group
CPAPDEVICE

Patients were treated with CPAP for three nights

Continues Positive Airway Pressure group

Eligibility Criteria

Age18 Years - 70 Years
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • 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.
  • For patients with no significant daytime sleepiness (ESS score \< 9), AHI≥10 times /h.
  • 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.

You may not qualify if:

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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Qilu Hospital of Shandong University

Jinan, Shandong, 250012, China

RECRUITING

Related Publications (6)

  • 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.

    PMID: 23910433BACKGROUND

  • 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.

    PMID: 31300334BACKGROUND

  • 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.

    PMID: 23513246BACKGROUND

  • 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.

    PMID: 32832300BACKGROUND

  • 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.

    PMID: 34383275BACKGROUND

  • 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.

    PMID: 19952061BACKGROUND

MeSH Terms

Conditions

Sleep Apnea, Obstructive

Condition Hierarchy (Ancestors)

Sleep Apnea SyndromesApneaRespiration DisordersRespiratory Tract DiseasesSleep Disorders, IntrinsicDyssomniasSleep Wake DisordersNervous System Diseases

Study Officials

  • enqi Zhao, master

    Qilu Hospital of Shandong University

    PRINCIPAL INVESTIGATOR

Central Study Contacts

Dedong Ma, doctor

CONTACT

18560082806ma@qiluhuxi.com

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
SINGLE
Who Masked
OUTCOMES ASSESSOR
Purpose
TREATMENT
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

August 14, 2022

First Posted

September 22, 2022

Study Start

August 20, 2022

Primary Completion

May 1, 2023

Study Completion

May 1, 2023

Last Updated

September 22, 2022

Record last verified: 2022-08

Data Sharing

IPD Sharing
Will not share

Locations

CN(1)