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

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

Sponsors

Lead Sponsor: Qilu Hospital of Shandong University

Source Qilu Hospital of Shandong University
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 1. 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. 2. 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

Overall Status Recruiting
Start Date 2022-08-22
Completion Date 2025-05-01
Primary Completion Date 2024-05-01
Phase N/A
Study Type Interventional
Primary Outcome
Measure Time Frame
AHI Change from Baseline AHI data at 1 month and 6 months.
Treatment failure rate about sixth month
Good compliance rate about sixth month
mean apnea time Change from Baseline mean apnea time data at 1 month and 6 months.
longest apnea time Change from Baseline longest apnea time data at 1 month and 6 months.
Mean oxygen saturation Change from Baseline Mean oxygen saturation data at 1 month and 6 months.
minimum oxygen saturation Change from Baseline minimum oxygen saturation data at 1 month and 6 months.
ODI Change from Baseline ODI data at 1 month and 6 months.
oxygen saturation < 90 % cumulative timesaturation Change from Baseline oxygen saturation < 90 % cumulative timesaturation data at 1 month and 6 months.
Gender by experiment finished:about 1 year
age by experiment finished:about 1 year
height by experiment finished:about 1 year
weight by experiment finished:about 1 year
Secondary Outcome
Measure Time Frame
total sleep time Change from Baseline total sleep time data at 1 month and 6 months.
REM time Change from Baseline REM time data at 1 month and 6 months.
NREM time Change from Baseline NREM time data at 1 month and 6 months.
sleep efficiency ( SE ) Change from Baseline sleep efficiency ( SE ) data at 1 month and 6 months.
awakening time Change from Baseline awakening time data at 1 month and 6 months.
awakening index ( Arl ) Change from Baseline awakening index ( Arl ) data at 1 month and 6 months.
heart rate Change from Baseline heart rate data at 1 month and 6 months.
blood pressure Change from Baseline blood pressure data at 1 month and 6 months.
Enrollment 186
Condition
Intervention

Intervention Type: Device

Intervention Name: CPAP

Description: At the beginning of the experiment we will choose the most suitable pressure and flow for the patient by titration,

Arm Group Label: CPAP group

Intervention Type: Device

Intervention Name: high-flow nasal canula oxygen therapy

Description: At the beginning of the experiment we will choose the most suitable pressure and flow for the patient by titration,

Arm Group Label: HFNC group

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 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;

Gender:

All

Minimum Age:

18 Years

Maximum Age:

70 Years

Healthy Volunteers:

No

Overall Official
Last Name Role Affiliation
Zhuo Han, master Principal Investigator Qilu Hospital of Shandong University
Overall Contact

Last Name: Dedong Ma, doctor

Phone: 18560082806

Email: [email protected]

Location
Facility: Status: Contact: Contact Backup: Qilu Hospital of Shandong University Dedong Ma, Doctor 18560082806 [email protected]
Location Countries

China

Verification Date

2022-07-01

Responsible Party

Type: Sponsor

Has Expanded Access No
Condition Browse
Number Of Arms 2
Arm Group

Label: CPAP group

Type: Active Comparator

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.

Label: HFNC group

Type: Experimental

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.

Acronym HFNC
Patient Data No
Study Design Info

Allocation: Randomized

Intervention Model: Parallel Assignment

Intervention Model Description: Subjects are divided into 2 groups:HFNC group and CPAP group

Primary Purpose: Treatment

Masking: None (Open Label)

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