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

S

Shandong University

Status

Enrolling

Conditions

Obstructive Sleep Apnea

Treatments

Device: high-flow nasal cannula oxygen therapy,
Device: CPAP

Study type

Interventional

Funder types

Other

Identifiers

NCT05549245
2022038

Details and patient eligibility

About

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.

Enrollment

194 estimated patients

Sex

All

Ages

18 to 70 years old

Volunteers

No Healthy Volunteers

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.

Trial design

Primary purpose

Treatment

Allocation

Randomized

Interventional model

Parallel Assignment

Masking

Single Blind

194 participants in 2 patient groups

High-flow Nasal Cannula Oxygen Therapy group
Experimental group
Treatment:
Device: high-flow nasal cannula oxygen therapy,
Continues Positive Airway Pressure group
Other group
Treatment:
Device: CPAP

Trial contacts and locations

1

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Central trial contact

Dedong Ma, doctor

Data sourced from clinicaltrials.gov

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