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

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

Sponsors

Lead Sponsor: Qilu Hospital of Shandong University

Source Qilu Hospital of Shandong University
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.

Overall Status Recruiting
Start Date 2022-08-20
Completion Date 2023-05-01
Primary Completion Date 2023-05-01
Phase N/A
Study Type Interventional
Primary Outcome
Measure Time Frame
AHI The first day of enrollment
AHI The fourth day of enrollment
Treatment failure rate The fourth day of enrollment
Good compliance rate The fourth day of enrollment
longest apnea time The first day of enrollment
longest apnea time The fourth day of enrollment
Mean oxygen saturation The first day of enrollment
Mean oxygen saturation The fourth day of enrollment
minimum oxygen saturation The first day of enrollment
minimum oxygen saturation The fourth day of enrollment
Secondary Outcome
Measure Time Frame
Gender The first day of enrollment
height The first day of enrollment
age The first day of enrollment
weight The first day of enrollment
total sleep time The first day of enrollment
total sleep time The fourth day of enrollment
Number of awakening The first day of enrollment
Number of awakening The fourth day of enrollment
Enrollment 194
Condition
Intervention

Intervention Type: Device

Intervention Name: high-flow nasal cannula oxygen therapy,

Description: Patients were treated with high-flow nasal cannula oxygen therapy for three nights

Arm Group Label: High-flow Nasal Cannula Oxygen Therapy group

Intervention Type: Device

Intervention Name: CPAP

Description: Patients were treated with CPAP for three nights

Arm Group Label: Continues Positive Airway Pressure group

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.

Gender:

All

Minimum Age:

18 Years

Maximum Age:

70 Years

Healthy Volunteers:

No

Overall Official
Last Name Role Affiliation
enqi Zhao, master Principal Investigator Qilu Hospital of Shandong University
Overall Contact

Last Name: Dedong Ma, doctor

Phone: 18560082806

Email: [email protected]

Location
Facility: Status: Contact: Contact Backup: Investigator: Qilu Hospital of Shandong University Dedong Ma, Doctor 18560082806 [email protected] enqi Zhao, doctor Principal Investigator
Location Countries

China

Verification Date

2022-08-01

Responsible Party

Type: Sponsor

Keywords
Has Expanded Access No
Condition Browse
Number Of Arms 2
Arm Group

Label: High-flow Nasal Cannula Oxygen Therapy group

Type: Experimental

Label: Continues Positive Airway Pressure group

Type: Other

Patient Data No
Study Design Info

Allocation: Randomized

Intervention Model: Parallel Assignment

Primary Purpose: Treatment

Masking: Single (Outcomes Assessor)

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