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

Primary Purpose

Obstructive Sleep Apnea

Status
Recruiting
Phase
Not Applicable
Locations
China
Study Type
Interventional
Intervention
high-flow nasal cannula oxygen therapy,
CPAP
Sponsored by
Qilu Hospital of Shandong University
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Obstructive Sleep Apnea focused on measuring Continues Positive Airway Pressure, High-flow Nasal Cannula Oxygen Therapy

Eligibility Criteria

18 Years - 70 Years (Adult, Older Adult)All SexesDoes not accept healthy volunteers

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:

  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.

Sites / Locations

  • Qilu Hospital of Shandong UniversityRecruiting

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

Other

Arm Label

High-flow Nasal Cannula Oxygen Therapy group

Continues Positive Airway Pressure group

Arm Description

Outcomes

Primary Outcome Measures

AHI
Apnea Hypopnea Index:The number of episodes of sleep apnea per hour
AHI
Apnea Hypopnea Index:The number of episodes of sleep apnea per hour
Treatment failure rate
Number of patients unable to tolerate treatment/enrollment
Good compliance rate
Number of patients treated for more than 4 hours per night/enrolled
longest apnea time
Maximum duration(s) of nocturnal sleep apnea in patients
longest apnea time
Maximum duration(s) of nocturnal sleep apnea in patients
Mean oxygen saturation
Mean oxygen saturation during the patient's night sleep
Mean oxygen saturation
Mean oxygen saturation during the patient's night sleep
minimum oxygen saturation
Lowest oxygen saturation during the patient's night sleep
minimum oxygen saturation
Lowest oxygen saturation during the patient's night sleep

Secondary Outcome Measures

Gender
Male and female
height
Height (in cm)
age
years
weight
Kg
total sleep time
Total sleep duration(min) of the patient at night
total sleep time
Total sleep duration(min) of the patient at night
Number of awakening
The number of awakenings during the patient's night sleep
Number of awakening
The number of awakenings during the patient's night sleep

Full Information

First Posted
August 14, 2022
Last Updated
September 19, 2022
Sponsor
Qilu Hospital of Shandong University
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1. Study Identification

Unique Protocol Identification Number
NCT05549245
Brief Title
Clinical Efficacy of High-flow Nasal Cannula Oxygen Therapy in Patients With Obstructive Sleep Apnea
Official Title
RCT Study of Short-term Clinical Efficacy of High Flow Nasal Catheter Oxygen Therapy for Obstructive Sleep Apnea
Study Type
Interventional

2. Study Status

Record Verification Date
August 2022
Overall Recruitment Status
Recruiting
Study Start Date
August 20, 2022 (Actual)
Primary Completion Date
May 2023 (Anticipated)
Study Completion Date
May 2023 (Anticipated)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Qilu Hospital of Shandong University

4. Oversight

Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
No

5. Study Description

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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Obstructive Sleep Apnea
Keywords
Continues Positive Airway Pressure, High-flow Nasal Cannula Oxygen Therapy

7. Study Design

Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
Outcomes Assessor
Allocation
Randomized
Enrollment
194 (Anticipated)

8. Arms, Groups, and Interventions

Arm Title
High-flow Nasal Cannula Oxygen Therapy group
Arm Type
Experimental
Arm Title
Continues Positive Airway Pressure group
Arm Type
Other
Intervention Type
Device
Intervention Name(s)
high-flow nasal cannula oxygen therapy,
Intervention Description
Patients were treated with high-flow nasal cannula oxygen therapy for three nights
Intervention Type
Device
Intervention Name(s)
CPAP
Intervention Description
Patients were treated with CPAP for three nights
Primary Outcome Measure Information:
Title
AHI
Description
Apnea Hypopnea Index:The number of episodes of sleep apnea per hour
Time Frame
The first day of enrollment
Title
AHI
Description
Apnea Hypopnea Index:The number of episodes of sleep apnea per hour
Time Frame
The fourth day of enrollment
Title
Treatment failure rate
Description
Number of patients unable to tolerate treatment/enrollment
Time Frame
The fourth day of enrollment
Title
Good compliance rate
Description
Number of patients treated for more than 4 hours per night/enrolled
Time Frame
The fourth day of enrollment
Title
longest apnea time
Description
Maximum duration(s) of nocturnal sleep apnea in patients
Time Frame
The first day of enrollment
Title
longest apnea time
Description
Maximum duration(s) of nocturnal sleep apnea in patients
Time Frame
The fourth day of enrollment
Title
Mean oxygen saturation
Description
Mean oxygen saturation during the patient's night sleep
Time Frame
The first day of enrollment
Title
Mean oxygen saturation
Description
Mean oxygen saturation during the patient's night sleep
Time Frame
The fourth day of enrollment
Title
minimum oxygen saturation
Description
Lowest oxygen saturation during the patient's night sleep
Time Frame
The first day of enrollment
Title
minimum oxygen saturation
Description
Lowest oxygen saturation during the patient's night sleep
Time Frame
The fourth day of enrollment
Secondary Outcome Measure Information:
Title
Gender
Description
Male and female
Time Frame
The first day of enrollment
Title
height
Description
Height (in cm)
Time Frame
The first day of enrollment
Title
age
Description
years
Time Frame
The first day of enrollment
Title
weight
Description
Kg
Time Frame
The first day of enrollment
Title
total sleep time
Description
Total sleep duration(min) of the patient at night
Time Frame
The first day of enrollment
Title
total sleep time
Description
Total sleep duration(min) of the patient at night
Time Frame
The fourth day of enrollment
Title
Number of awakening
Description
The number of awakenings during the patient's night sleep
Time Frame
The first day of enrollment
Title
Number of awakening
Description
The number of awakenings during the patient's night sleep
Time Frame
The fourth day of enrollment

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
70 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria: 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. Exclusion Criteria: 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.
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
Dedong Ma, doctor
Phone
18560082806
Email
ma@qiluhuxi.com
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
enqi Zhao, master
Organizational Affiliation
Qilu Hospital of Shandong University
Official's Role
Principal Investigator
Facility Information:
Facility Name
Qilu Hospital of Shandong University
City
Jinan
State/Province
Shandong
ZIP/Postal Code
250012
Country
China
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Dedong Ma, Doctor
Phone
18560082806
Email
ma@qiluhuxi.com
First Name & Middle Initial & Last Name & Degree
Enqi Zhao, doctor
Phone
15550834269
Email
zeq@qiluhuxi.com
First Name & Middle Initial & Last Name & Degree
enqi Zhao, doctor

12. IPD Sharing Statement

Plan to Share IPD
No
Citations:
PubMed Identifier
23910433
Citation
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.
Results Reference
background
PubMed Identifier
31300334
Citation
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.
Results Reference
background
PubMed Identifier
23513246
Citation
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.
Results Reference
background
PubMed Identifier
32832300
Citation
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.
Results Reference
background
PubMed Identifier
34383275
Citation
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.
Results Reference
background
PubMed Identifier
19952061
Citation
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.
Results Reference
background

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

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