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

Not Applicable

Recruiting

• Conditions: High Flow Nasal Canula; Obstructive Sleep Apnea; Continuous Positive Airway Pressure Ventilation
• Interventions: Device: CPAP; Device: high-flow nasal canula oxygen therapy

• Registration Number: NCT05549310
• Lead Sponsor: 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

Study Timeline

• Status Verified: 2022-07
• Study First Submitted: 2022-08-14
• Study Start: 2022-08-22
• Study First Submitted QC: 2022-09-19
• Last Update Submitted: 2022-09-19
• Study First Posted: 2022-09-22
• Last Update Posted: 2022-09-22
• Primary Completion: 2024-05
• Study Completion: 2025-05

Recruitment & Eligibility

• Status: RECRUITING
• Sex: All
• Target Recruitment: 186

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;

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
CPAP group	CPAP	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	high-flow nasal canula oxygen therapy	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.

Primary Outcome Measures

Name	Time	Method
age	by experiment finished:about 1 year	general condition
height	by experiment finished:about 1 year	general condition
Treatment failure rate	about sixth month	The data of the patient's AHI will be collected to evaluate the change of the patient's device adaptation.
minimum oxygen saturation	Change from Baseline minimum oxygen saturation data at 1 month and 6 months.	The data will be collected to evaluate the change of the patient's oxygen saturation.
longest apnea time	Change from Baseline longest apnea time data at 1 month and 6 months.	The data of the patient's mean apnea time will be collected to evaluate the change of the patient's sleep.
oxygen saturation < 90 % cumulative timesaturation	Change from Baseline oxygen saturation < 90 % cumulative timesaturation data at 1 month and 6 months.	The data will be collected to evaluate the change of the patient's oxygen saturation.
mean apnea time	Change from Baseline mean apnea time data at 1 month and 6 months.	The data of the patient's mean apnea time will be collected to evaluate the change of the patient's sleep.
Mean oxygen saturation	Change from Baseline Mean oxygen saturation data at 1 month and 6 months.	The data of the patient's mean apnea time will be collected to evaluate the change of the patient's oxygen saturation.
ODI	Change from Baseline ODI data at 1 month and 6 months.	The data will be collected to evaluate the change of the patient's oxygen saturation.
AHI	Change from Baseline AHI data at 1 month and 6 months.	The data of the patient's AHI will be collected to evaluate the change of the patient's sleep.
Good compliance rate	about sixth month	refers to the replacement of patients during treatment to another group of respiratory support or patients give up treatment
Gender	by experiment finished:about 1 year	general condition
weight	by experiment finished:about 1 year	general condition

Secondary Outcome Measures

Name	Time	Method
total sleep time	Change from Baseline total sleep time data at 1 month and 6 months.	The data will be collected to evaluate the change of the patient's sleep.
NREM time	Change from Baseline NREM time data at 1 month and 6 months.	The data will be collected to evaluate the change of the patient's sleep.
REM time	Change from Baseline REM time data at 1 month and 6 months.	The data will be collected to evaluate the change of the patient's sleep.
sleep efficiency ( SE )	Change from Baseline sleep efficiency ( SE ) data at 1 month and 6 months.	The data will be collected to evaluate the change of the patient's sleep.
blood pressure	Change from Baseline blood pressure data at 1 month and 6 months.	The data will be collected to evaluate the change of the patient's circulation condition..
awakening time	Change from Baseline awakening time data at 1 month and 6 months.	The data will be collected to evaluate the change of the patient's sleep.
awakening index ( Arl )	Change from Baseline awakening index ( Arl ) data at 1 month and 6 months.	The data will be collected to evaluate the change of the patient's sleep.
heart rate	Change from Baseline heart rate data at 1 month and 6 months.	The data will be collected to evaluate the change of the patient's circulation condition.

Trial Locations

Locations (1)

Qilu Hospital of Shandong University; 🇨🇳 Jinan, Shandong, China