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

Study Overview
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Brief Summary
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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.

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

Conditions
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Obstructive Sleep Apnea

Intervention / Treatment
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* Device: high-flow nasal cannula oxygen therapy,
* Device: CPAP


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: 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: Patients who cannot tolerate non-invasive ventilator or transnasal high-flow oxygen therapy. Ongoing treatment may affect sleep, such as sedatives, hypnotics, muscle relaxants, etc. Hemodynamic instability. Severe respiratory diseases.

Ages Eligible for Study
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Minimum Age: 18 Years
Maximum Age: 70 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Single


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: High-flow Nasal Cannula Oxygen Therapy group<br> | Device: high-flow nasal cannula oxygen therapy,<br>* Patients were treated with high-flow nasal cannula oxygen therapy for three nights<br>|
| Other: Continues Positive Airway Pressure group<br> | Device: CPAP<br>* Patients were treated with CPAP for three nights<br>|

What is the study measuring?
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Primary Outcome Measures

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

Secondary Outcome Measures

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

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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Continues Positive Airway Pressure, High-flow Nasal Cannula Oxygen Therapy