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

Not Applicable

• Conditions: Obstructive Sleep Apnea
• Interventions: Device: high-flow nasal cannula oxygen therapy,; Device: CPAP

• Registration Number: NCT05549245
• Lead Sponsor: 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.

Detailed Description

Not available

Study Timeline

• Status Verified: 2022-08
• Study First Submitted: 2022-08-14
• Study Start: 2022-08-20
• Study First Submitted QC: 2022-09-19
• Last Update Submitted: 2022-09-19
• Study First Posted: 2022-09-22
• Last Update Posted: 2022-09-22
• Primary Completion: 2023-05
• Study Completion: 2023-05

Recruitment & Eligibility

• Status: UNKNOWN
• Sex: All
• Target Recruitment: 194

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.

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
High-flow Nasal Cannula Oxygen Therapy group	high-flow nasal cannula oxygen therapy,	-
Continues Positive Airway Pressure group	CPAP	-

Primary Outcome Measures

Name	Time	Method
Good compliance rate	The fourth day of enrollment	Number of patients treated for more than 4 hours per night/enrolled
AHI	The fourth day of enrollment	Apnea Hypopnea Index:The number of episodes of sleep apnea per hour
Treatment failure rate	The fourth day of enrollment	Number of patients unable to tolerate treatment/enrollment
longest apnea time	The fourth day of enrollment	Maximum duration(s) of nocturnal sleep apnea in patients
minimum oxygen saturation	The fourth day of enrollment	Lowest oxygen saturation during the patient's night sleep
Mean oxygen saturation	The fourth day of enrollment	Mean oxygen saturation during the patient's night sleep

Secondary Outcome Measures

Name	Time	Method
age	The first day of enrollment	years
total sleep time	The fourth day of enrollment	Total sleep duration(min) of the patient at night
Number of awakening	The fourth day of enrollment	The number of awakenings during the patient's night sleep
Gender	The first day of enrollment	Male and female
weight	The first day of enrollment	Kg
height	The first day of enrollment	Height (in cm)

Trial Locations

Locations (1)

Qilu Hospital of Shandong University; 🇨🇳 Jinan, Shandong, China