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Long-term Effect of High Flow Nasal Canula Therapy on Obstructive Sleep Apnea (HFNC)

Primary Purpose

Obstructive Sleep Apnea, High Flow Nasal Canula, Continuous Positive Airway Pressure Ventilation

Status
Recruiting
Phase
Not Applicable
Locations
China
Study Type
Interventional
Intervention
CPAP
high-flow nasal canula oxygen therapy
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

Eligibility Criteria

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

Inclusion Criteria:

meet any one of these

  • 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; 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:

meet any one of these

  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

Active Comparator

Experimental

Arm Label

CPAP group

HFNC group

Arm Description

CPAP group : The first stage:receiving CPAP treatment for 6 hours / night, for 1 month. Patients in the treatment group first use pressure titration, select the appropriate pressure after treatment. The second stage ( cohort study ) : After one month of the first stage of treatment, patients voluntarily continued to receive treatment and observers were included in the second stage of treatment. CPAP group continued to receive corresponding treatment for 6 months.

HFNC group : The first stage:receiving HFNC treatment for 6 hours / night, for 1 month. Patients in the treatment group first use pressure titration, select the appropriate pressure after treatment. The second stage ( cohort study ) : After one month of the first stage of treatment, patients voluntarily continued to receive treatment and observers were included in the second stage of treatment. HFNC group continued to receive corresponding treatment for 6 months.

Outcomes

Primary Outcome Measures

AHI
The data of the patient's AHI will be collected to evaluate the change of the patient's sleep.
Treatment failure rate
The data of the patient's AHI will be collected to evaluate the change of the patient's device adaptation.
Good compliance rate
refers to the replacement of patients during treatment to another group of respiratory support or patients give up treatment
mean apnea time
The data of the patient's mean apnea time will be collected to evaluate the change of the patient's sleep.
longest apnea time
The data of the patient's mean apnea time will be collected to evaluate the change of the patient's sleep.
Mean oxygen saturation
The data of the patient's mean apnea time will be collected to evaluate the change of the patient's oxygen saturation.
minimum oxygen saturation
The data will be collected to evaluate the change of the patient's oxygen saturation.
ODI
The data will be collected to evaluate the change of the patient's oxygen saturation.
oxygen saturation < 90 % cumulative timesaturation
The data will be collected to evaluate the change of the patient's oxygen saturation.
Gender
general condition
age
general condition
height
general condition
weight
general condition

Secondary Outcome Measures

total sleep time
The data will be collected to evaluate the change of the patient's sleep.
REM time
The data will be collected to evaluate the change of the patient's sleep.
NREM time
The data will be collected to evaluate the change of the patient's sleep.
sleep efficiency ( SE )
The data will be collected to evaluate the change of the patient's sleep.
awakening time
The data will be collected to evaluate the change of the patient's sleep.
awakening index ( Arl )
The data will be collected to evaluate the change of the patient's sleep.
heart rate
The data will be collected to evaluate the change of the patient's circulation condition.
blood pressure
The data will be collected to evaluate the change of the patient's circulation condition..

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
NCT05549310
Brief Title
Long-term Effect of High Flow Nasal Canula Therapy on Obstructive Sleep Apnea
Acronym
HFNC
Official Title
Long-term Effect of High Flow Nasal Canula Therapy on Obstructive Sleep Apnea
Study Type
Interventional

2. Study Status

Record Verification Date
July 2022
Overall Recruitment Status
Recruiting
Study Start Date
August 22, 2022 (Actual)
Primary Completion Date
May 2024 (Anticipated)
Study Completion Date
May 2025 (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
Product Manufactured in and Exported from the U.S.
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 Continuos Positive Airway Pressure group for 1 month of treatment. Sleep respiration monitoring data including AHI, blood oxygen saturation decline index (ODI) and minimum blood oxygen saturation were recorded before and after treatment. After one month of the first stage of treatment, patients voluntarily continued to receive treatment and observers were included in the second stage of treatment. HFNC group and CPAP group continue to receive corresponding treatment for 6 months.Before and after the study, sleep respiratory monitoring datas,treatment failure rate,good compliance rate are recorded.
Detailed Description
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 Continuos Positive Airway Pressure group. Procedure The first stage ( RCT study ) : subjects were divided into HFNC group and CPAP group, HFNC group received HFNC treatment 6 hours / night, 1 month ; CPAP group : receiving CPAP treatment for 6 hours / night, for 1 month. Patients in the treatment group first use pressure titration, select the appropriate pressure after treatment. Patients receiving CPAP treatment were enrolled in the study. Pressure titration was used first, and appropriate pressure was selected before treatment. The initial gas flow rate of patients receiving HFNC treatment was set to 30 - 40 L / min, and FiO2 was titrated to maintain the pulse oxygen saturation above 92 %, which was adjusted according to the patient 's tolerance and comfort.Record nightly sleep respiratory monitoring data, including 1 sleep characteristics : total sleep time, REM time, NREM time, sleep efficiency ( SE ) ; 2 awakening time, awakening index ( Arl ) ; aHI, average apnea time, longest apnea time ; 4 the cumulative time of average oxygen saturation, minimum oxygen saturation, ODI, and oxygen saturation below 90 % ; 5 heart rate, blood pressure, etc. The second stage ( cohort study ) : After one month of the first stage of treatment, patients voluntarily continued to receive treatment and observers were included in the second stage of treatment. HFNC group and CPAP group continued to receive corresponding treatment for 6 months. Follow-up after each stage of treatment, recording sleep respiratory monitoring data, including the main endpoint : 1 Treatment failure rate 2.treatment compliance

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Obstructive Sleep Apnea, High Flow Nasal Canula, Continuous Positive Airway Pressure Ventilation

7. Study Design

Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Model Description
Subjects are divided into 2 groups:HFNC group and CPAP group
Masking
None (Open Label)
Allocation
Randomized
Enrollment
186 (Anticipated)

8. Arms, Groups, and Interventions

Arm Title
CPAP group
Arm Type
Active Comparator
Arm Description
CPAP group : The first stage:receiving CPAP treatment for 6 hours / night, for 1 month. Patients in the treatment group first use pressure titration, select the appropriate pressure after treatment. The second stage ( cohort study ) : After one month of the first stage of treatment, patients voluntarily continued to receive treatment and observers were included in the second stage of treatment. CPAP group continued to receive corresponding treatment for 6 months.
Arm Title
HFNC group
Arm Type
Experimental
Arm Description
HFNC group : The first stage:receiving HFNC treatment for 6 hours / night, for 1 month. Patients in the treatment group first use pressure titration, select the appropriate pressure after treatment. The second stage ( cohort study ) : After one month of the first stage of treatment, patients voluntarily continued to receive treatment and observers were included in the second stage of treatment. HFNC group continued to receive corresponding treatment for 6 months.
Intervention Type
Device
Intervention Name(s)
CPAP
Intervention Description
At the beginning of the experiment we will choose the most suitable pressure and flow for the patient by titration,
Intervention Type
Device
Intervention Name(s)
high-flow nasal canula oxygen therapy
Intervention Description
At the beginning of the experiment we will choose the most suitable pressure and flow for the patient by titration,
Primary Outcome Measure Information:
Title
AHI
Description
The data of the patient's AHI will be collected to evaluate the change of the patient's sleep.
Time Frame
Change from Baseline AHI data at 1 month and 6 months.
Title
Treatment failure rate
Description
The data of the patient's AHI will be collected to evaluate the change of the patient's device adaptation.
Time Frame
about sixth month
Title
Good compliance rate
Description
refers to the replacement of patients during treatment to another group of respiratory support or patients give up treatment
Time Frame
about sixth month
Title
mean apnea time
Description
The data of the patient's mean apnea time will be collected to evaluate the change of the patient's sleep.
Time Frame
Change from Baseline mean apnea time data at 1 month and 6 months.
Title
longest apnea time
Description
The data of the patient's mean apnea time will be collected to evaluate the change of the patient's sleep.
Time Frame
Change from Baseline longest apnea time data at 1 month and 6 months.
Title
Mean oxygen saturation
Description
The data of the patient's mean apnea time will be collected to evaluate the change of the patient's oxygen saturation.
Time Frame
Change from Baseline Mean oxygen saturation data at 1 month and 6 months.
Title
minimum oxygen saturation
Description
The data will be collected to evaluate the change of the patient's oxygen saturation.
Time Frame
Change from Baseline minimum oxygen saturation data at 1 month and 6 months.
Title
ODI
Description
The data will be collected to evaluate the change of the patient's oxygen saturation.
Time Frame
Change from Baseline ODI data at 1 month and 6 months.
Title
oxygen saturation < 90 % cumulative timesaturation
Description
The data will be collected to evaluate the change of the patient's oxygen saturation.
Time Frame
Change from Baseline oxygen saturation < 90 % cumulative timesaturation data at 1 month and 6 months.
Title
Gender
Description
general condition
Time Frame
by experiment finished:about 1 year
Title
age
Description
general condition
Time Frame
by experiment finished:about 1 year
Title
height
Description
general condition
Time Frame
by experiment finished:about 1 year
Title
weight
Description
general condition
Time Frame
by experiment finished:about 1 year
Secondary Outcome Measure Information:
Title
total sleep time
Description
The data will be collected to evaluate the change of the patient's sleep.
Time Frame
Change from Baseline total sleep time data at 1 month and 6 months.
Title
REM time
Description
The data will be collected to evaluate the change of the patient's sleep.
Time Frame
Change from Baseline REM time data at 1 month and 6 months.
Title
NREM time
Description
The data will be collected to evaluate the change of the patient's sleep.
Time Frame
Change from Baseline NREM time data at 1 month and 6 months.
Title
sleep efficiency ( SE )
Description
The data will be collected to evaluate the change of the patient's sleep.
Time Frame
Change from Baseline sleep efficiency ( SE ) data at 1 month and 6 months.
Title
awakening time
Description
The data will be collected to evaluate the change of the patient's sleep.
Time Frame
Change from Baseline awakening time data at 1 month and 6 months.
Title
awakening index ( Arl )
Description
The data will be collected to evaluate the change of the patient's sleep.
Time Frame
Change from Baseline awakening index ( Arl ) data at 1 month and 6 months.
Title
heart rate
Description
The data will be collected to evaluate the change of the patient's circulation condition.
Time Frame
Change from Baseline heart rate data at 1 month and 6 months.
Title
blood pressure
Description
The data will be collected to evaluate the change of the patient's circulation condition..
Time Frame
Change from Baseline blood pressure data at 1 month and 6 months.

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: meet any one of these 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; 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: meet any one of these 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
Zhuo Han, 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
Zhuo Han, Master
Phone
17860623815
Email
1783498197@qq.com

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
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
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
result

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Long-term Effect of High Flow Nasal Canula Therapy on Obstructive Sleep Apnea

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