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

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.

Study Overview

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

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 Type: Interventional
• Enrollment (Anticipated): 186
• Phase: Not Applicable

Contacts and Locations

• Study Contact: Name: Dedong Ma, Doctor; Phone Number: 18560082806; Email: ma@qiluhuxi.com

Study Locations

• China
  • Shandong
    • Jinan, Shandong, China, 250012
      • Recruiting
      • Qilu Hospital of Shandong University
      • Contact: Dedong Ma, Doctor; Phone Number: 18560082806; Email: ma@qiluhuxi.com
      • Contact: Zhuo Han, Master; Phone Number: 17860623815; Email: 1783498197@qq.com

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 16 years to 68 years (Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

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 Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: None (Open Label)

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Active Comparator: CPAP group; 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.	Device: CPAP; At the beginning of the experiment we will choose the most suitable pressure and flow for the patient by titration，
Experimental: HFNC group; 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.	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，

What is the study measuring?

Primary Outcome Measures

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

Secondary Outcome Measures

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

Collaborators and Investigators

• Sponsor: Qilu Hospital of Shandong University
• Investigators: Principal Investigator: Zhuo Han, master, Qilu Hospital of Shandong University

Publications and helpful links

General Publications

• 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.
• 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.
• 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.
• 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.
• 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.
• 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.

Study record dates

Study Major Dates

• Study Start (Actual): August 22, 2022
• Primary Completion (Anticipated): May 1, 2024
• Study Completion (Anticipated): May 1, 2025

Study Registration Dates

• First Submitted: August 14, 2022
• First Submitted That Met QC Criteria: September 19, 2022
• First Posted (Actual): September 22, 2022

Study Record Updates

• Last Update Posted (Actual): September 22, 2022
• Last Update Submitted That Met QC Criteria: September 19, 2022
• Last Verified: July 1, 2022

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Nervous System Diseases; Respiratory Tract Diseases; Respiration Disorders; Sleep Disorders, Intrinsic; Dyssomnias; Sleep Wake Disorders; Signs and Symptoms, Respiratory; Sleep Apnea Syndromes; Sleep Apnea, Obstructive; Apnea
• Other Study ID Numbers: 2022037

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: No

Drug and device information, study documents

• 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