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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

Status
UNKNOWN
Phases
NA
Study type
Interventional
Source
ClinicalTrials.gov
Registry ID
NCT05549245
Enrollment
194
Registered
2022-09-22
Start date
2022-08-20
Completion date
2023-05-31
Last updated
2022-09-22

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Obstructive Sleep Apnea

Keywords

Continues Positive Airway Pressure, High-flow Nasal Cannula Oxygen Therapy

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.

Interventions

DEVICEhigh-flow nasal cannula oxygen therapy,

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

DEVICECPAP

Patients were treated with CPAP for three nights

Sponsors

Qilu Hospital of Shandong University
Lead SponsorOTHER

Study design

Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
SINGLE (Outcomes Assessor)

Eligibility

Sex/Gender
ALL
Age
18 Years to 70 Years
Healthy volunteers
No

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.

Design outcomes

Primary

MeasureTime frameDescription
minimum oxygen saturationThe first day of enrollmentLowest oxygen saturation during the patient's night sleep
AHIThe first day of enrollmentApnea Hypopnea Index:The number of episodes of sleep apnea per hour
Treatment failure rateThe fourth day of enrollmentNumber of patients unable to tolerate treatment/enrollment
Good compliance rateThe fourth day of enrollmentNumber of patients treated for more than 4 hours per night/enrolled
longest apnea timeThe first day of enrollmentMaximum duration(s) of nocturnal sleep apnea in patients
Mean oxygen saturationThe first day of enrollmentMean oxygen saturation during the patient's night sleep

Secondary

MeasureTime frameDescription
GenderThe first day of enrollmentMale and female
heightThe first day of enrollmentHeight (in cm)
ageThe first day of enrollmentyears
weightThe first day of enrollmentKg
total sleep timeThe first day of enrollmentTotal sleep duration(min) of the patient at night
Number of awakeningThe first day of enrollmentThe number of awakenings during the patient's night sleep

Countries

China

Contacts

Primary ContactDedong Ma, doctor
ma@qiluhuxi.com18560082806

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026