NCT05549310

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

• Status: Unknown
• Phase: N/A
• Study type: Interventional
• Enrollment: 186 (estimated)
• Sponsor: Qilu Hospital of Shandong University · Academic / Other
• Sex: All
• Age: 18 Years – 70 Years
• Healthy volunteers: Not accepted

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

Conditions

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

Interventions

Type	Name	Description
DEVICE	CPAP	At the beginning of the experiment we will choose the most suitable pressure and flow for the patient by titration，
DEVICE	high-flow nasal canula oxygen therapy	At the beginning of the experiment we will choose the most suitable pressure and flow for the patient by titration，

Timeline

• Start date: 2022-08-22
• Primary completion: 2024-05-01
• Completion: 2025-05-01
• First posted: 2022-09-22
• Last updated: 2022-09-22

Locations

1 site across 1 country: China