Clinical trial NCT05549245: Clinical Efficacy of High-flow Nasal Cannula Oxygen Therapy in Patients With Obstructive Sleep Apnea
Official title: RCT Study of Short-term Clinical Efficacy of High Flow Nasal Catheter Oxygen Therapy for Obstructive Sleep Apnea
Study type: INTERVENTIONAL
Overall status: UNKNOWN
Phase: NA
Conditions: Obstructive Sleep Apnea
Keywords: Continues Positive Airway Pressure
High-flow Nasal Cannula Oxygen Therapy
Lead sponsor: Qilu Hospital of Shandong University
Sponsor class: OTHER
First posted: 2022-09-22
Enrollment: 194
Sex: ALL
Minimum age (years): 18
Maximum age (years): 70
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

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


Eligibility criteria: 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.

Primary outcomes:
measure: AHI
timeFrame: The first day of enrollment
measure: AHI
timeFrame: The fourth day of enrollment
measure: Treatment failure rate
timeFrame: The fourth day of enrollment
measure: Good compliance rate
timeFrame: The fourth day of enrollment
measure: longest apnea time
timeFrame: The first day of enrollment
measure: longest apnea time
timeFrame: The fourth day of enrollment
measure: Mean oxygen saturation
timeFrame: The first day of enrollment
measure: Mean oxygen saturation
timeFrame: The fourth day of enrollment
measure: minimum oxygen saturation
timeFrame: The first day of enrollment
measure: minimum oxygen saturation
timeFrame: The fourth day of enrollment
Secondary outcomes:
measure: Gender
timeFrame: The first day of enrollment
measure: height
timeFrame: The first day of enrollment
measure: age
timeFrame: The first day of enrollment
measure: weight
timeFrame: The first day of enrollment
measure: total sleep time
timeFrame: The first day of enrollment
measure: total sleep time
timeFrame: The fourth day of enrollment
measure: Number of awakening
timeFrame: The first day of enrollment
measure: Number of awakening
timeFrame: The fourth day of enrollment
Other outcomes:
Locations:
city: Jinan
country: China
facility: Qilu Hospital of Shandong University
state: Shandong
Study officials:
affiliation: Qilu Hospital of Shandong University
name: enqi Zhao, master
role: PRINCIPAL_INVESTIGATOR
References:
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.
citation: 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.
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.
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.
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.
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.