Clinical trial NCT05549310: Long-term Effect of High Flow Nasal Canula Therapy on Obstructive Sleep Apnea
Official title: Long-term Effect of High Flow Nasal Canula Therapy on Obstructive Sleep Apnea
Study type: INTERVENTIONAL
Overall status: UNKNOWN
Phase: NA
Conditions: Obstructive Sleep Apnea
High Flow Nasal Canula
Continuous Positive Airway Pressure Ventilation
Lead sponsor: Qilu Hospital of Shandong University
Sponsor class: OTHER
First posted: 2022-09-22
Enrollment: 186
Sex: ALL
Minimum age (years): 18
Maximum age (years): 70
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Intervention model description: Subjects are divided into 2 groups:HFNC group and CPAP group
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 Continuos Positive Airway Pressure group for 1 month of treatment. Sleep respiration monitoring data including AHI, blood oxygen saturation decline index (ODI) and minimum blood oxygen saturation were recorded before and after treatment.

After one month of the first stage of treatment, patients voluntarily continued to receive treatment and observers were included in the second stage of treatment. HFNC group and CPAP group continue to receive corresponding treatment for 6 months.Before and after the study, sleep respiratory monitoring datas,treatment failure rate，good compliance rate are recorded.

Detailed description: 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 Continuos Positive Airway Pressure group.

Procedure

1. The first stage ( RCT study ) : subjects were divided into HFNC group and CPAP group, HFNC group received HFNC treatment 6 hours / night, 1 month ; CPAP group : receiving CPAP treatment for 6 hours / night, for 1 month. Patients in the treatment group first use pressure titration, select the appropriate pressure after treatment.

   Patients receiving CPAP treatment were enrolled in the study. Pressure titration was used first, and appropriate pressure was selected before treatment. The initial gas flow rate of patients receiving HFNC treatment was set to 30 - 40 L / min, and FiO2 was titrated to maintain the pulse oxygen saturation above 92 %, which was adjusted according to the patient 's tolerance and comfort.Record nightly sleep respiratory monitoring data, including 1 sleep characteristics : total sleep time, REM time, NREM time, sleep efficiency ( SE ) ; 2 awakening time, awakening index ( Arl ) ; aHI, average apnea time, longest apnea time ; 4 the cumulative time of average oxygen saturation, minimum oxygen saturation, ODI, and oxygen saturation below 90 % ; 5 heart rate, blood pressure, etc.
2. The second stage ( cohort study ) : After one month of the first stage of treatment, patients voluntarily continued to receive treatment and observers were included in the second stage of treatment. HFNC group and CPAP group continued to receive corresponding treatment for 6 months. Follow-up after each stage of treatment, recording sleep respiratory monitoring data, including the main endpoint : 1 Treatment failure rate 2.treatment compliance

Eligibility criteria: Inclusion Criteria:

meet any one of these

* 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; 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:

meet any one of these

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: Change from Baseline AHI data at 1 month and 6 months.
measure: Treatment failure rate
timeFrame: about sixth month
measure: Good compliance rate
timeFrame: about sixth month
measure: mean apnea time
timeFrame: Change from Baseline mean apnea time data at 1 month and 6 months.
measure: longest apnea time
timeFrame: Change from Baseline longest apnea time data at 1 month and 6 months.
measure: Mean oxygen saturation
timeFrame: Change from Baseline Mean oxygen saturation data at 1 month and 6 months.
measure: minimum oxygen saturation
timeFrame: Change from Baseline minimum oxygen saturation data at 1 month and 6 months.
measure: ODI
timeFrame: Change from Baseline ODI data at 1 month and 6 months.
measure: oxygen saturation < 90 % cumulative timesaturation
timeFrame: Change from Baseline oxygen saturation < 90 % cumulative timesaturation data at 1 month and 6 months.
measure: Gender
timeFrame: by experiment finished:about 1 year
measure: age
timeFrame: by experiment finished:about 1 year
measure: height
timeFrame: by experiment finished:about 1 year
measure: weight
timeFrame: by experiment finished:about 1 year
Secondary outcomes:
measure: total sleep time
timeFrame: Change from Baseline total sleep time data at 1 month and 6 months.
measure: REM time
timeFrame: Change from Baseline REM time data at 1 month and 6 months.
measure: NREM time
timeFrame: Change from Baseline NREM time data at 1 month and 6 months.
measure: sleep efficiency ( SE )
timeFrame: Change from Baseline sleep efficiency ( SE ) data at 1 month and 6 months.
measure: awakening time
timeFrame: Change from Baseline awakening time data at 1 month and 6 months.
measure: awakening index ( Arl )
timeFrame: Change from Baseline awakening index ( Arl ) data at 1 month and 6 months.
measure: heart rate
timeFrame: Change from Baseline heart rate data at 1 month and 6 months.
measure: blood pressure
timeFrame: Change from Baseline blood pressure data at 1 month and 6 months.
Other outcomes:
Locations:
city: Jinan
country: China
facility: Qilu Hospital of Shandong University
state: Shandong
Study officials:
affiliation: Qilu Hospital of Shandong University
name: Zhuo Han, master
role: PRINCIPAL_INVESTIGATOR
References:
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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.