Clinical Efficacy of High-flow Nasal Cannula Oxygen Therapy in Patients With Obstructive Sleep Apnea

Obstructive Sleep Apnea Clinical Trial

Official title:

RCT Study of Short-term Clinical Efficacy of High Flow Nasal Catheter Oxygen Therapy for Obstructive Sleep Apnea

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT05549245
• Other study ID #: 2022038
• Status: Recruiting
• Phase: N/A
• Start date: August 20, 2022
• Est. completion date: May 2023

Study information

• Verified date: August 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 Continues Positive Airway Pressure group for 3 days of treatment. Sleep monitoring was performed on the first and fourth day of enrollment.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 194
• Est. completion date: May 2023
• Est. primary completion date: May 2023
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years to 70 Years

Eligibility

Inclusion Criteria:

1. 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.

2. 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:

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
• Obstructive Sleep Apnea
• Sleep Apnea Syndromes
• Sleep Apnea, Obstructive

Intervention

Device:
• high-flow nasal cannula oxygen therapy,
Patients were treated with high-flow nasal cannula oxygen therapy for three nights
• CPAP
Patients were treated with CPAP for three nights

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	Apnea Hypopnea Index:The number of episodes of sleep apnea per hour	The first day of enrollment
Primary	AHI	Apnea Hypopnea Index:The number of episodes of sleep apnea per hour	The fourth day of enrollment
Primary	Treatment failure rate	Number of patients unable to tolerate treatment/enrollment	The fourth day of enrollment
Primary	Good compliance rate	Number of patients treated for more than 4 hours per night/enrolled	The fourth day of enrollment
Primary	longest apnea time	Maximum duration(s) of nocturnal sleep apnea in patients	The first day of enrollment
Primary	longest apnea time	Maximum duration(s) of nocturnal sleep apnea in patients	The fourth day of enrollment
Primary	Mean oxygen saturation	Mean oxygen saturation during the patient's night sleep	The first day of enrollment
Primary	Mean oxygen saturation	Mean oxygen saturation during the patient's night sleep	The fourth day of enrollment
Primary	minimum oxygen saturation	Lowest oxygen saturation during the patient's night sleep	The first day of enrollment
Primary	minimum oxygen saturation	Lowest oxygen saturation during the patient's night sleep	The fourth day of enrollment
Secondary	Gender	Male and female	The first day of enrollment
Secondary	height	Height (in cm)	The first day of enrollment
Secondary	age	years	The first day of enrollment
Secondary	weight	Kg	The first day of enrollment
Secondary	total sleep time	Total sleep duration(min) of the patient at night	The first day of enrollment
Secondary	total sleep time	Total sleep duration(min) of the patient at night	The fourth day of enrollment
Secondary	Number of awakening	The number of awakenings during the patient's night sleep	The first day of enrollment
Secondary	Number of awakening	The number of awakenings during the patient's night sleep	The fourth day of enrollment