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

Obstructive Sleep Apnea Clinical Trial

— HFNC  

Official title:

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

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT05549310
• Other study ID #: 2022037
• Status: Recruiting
• Phase: N/A
• Start date: August 22, 2022
• Est. completion date: May 2025

Study information

• Verified date: July 2022
• Source: Qilu Hospital of Shandong University
• Contact: Dedong Ma, doctor
• Phone: 18560082806
• Email: ma[@]qiluhuxi.com
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

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

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 186
• Est. completion date: May 2025
• Est. primary completion date: May 2024
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years to 70 Years

Eligibility

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; ? 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;

Related Conditions & MeSH terms

• Apnea
• Continuous Positive Airway Pressure Ventilation
• Obstructive Sleep Apnea
• Sleep Apnea Syndromes
• Sleep Apnea, Obstructive

Intervention

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

Locations

Country	Name	City	State
China	Qilu Hospital of Shandong University	Jinan	Shandong

Sponsors (1)

Lead Sponsor	Collaborator
Qilu Hospital of Shandong University

Country where clinical trial is conducted

China, 

References & Publications (6)

Benjafield AV, Ayas NT, Eastwood PR, Heinzer R, Ip MSM, Morrell MJ, Nunez CM, Patel SR, Penzel T, Pépin 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. Review. — View 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. Review. — View 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. — View 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. — View 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. — View 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. — View Citation

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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.
Primary	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
Primary	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
Primary	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.
Primary	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.
Primary	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.
Primary	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.
Primary	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.
Primary	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.
Primary	Gender	general condition	by experiment finished:about 1 year
Primary	age	general condition	by experiment finished:about 1 year
Primary	height	general condition	by experiment finished:about 1 year
Primary	weight	general condition	by experiment finished:about 1 year
Secondary	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.
Secondary	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.
Secondary	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.
Secondary	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.
Secondary	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.
Secondary	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.
Secondary	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.
Secondary	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.