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

September 19, 2022 updated by: Qilu Hospital of Shandong University

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

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.

Study Overview

Status

Recruiting

Conditions

Intervention / Treatment

Study Type

Interventional

Enrollment (Anticipated)

194

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Contact

Study Locations

  • China
    • Shandong
      • Jinan, Shandong, China, 250012
        • Recruiting
        • Qilu Hospital of Shandong University
        • Contact:
        • Contact:
        • Principal Investigator:
          • enqi Zhao, doctor

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

16 years to 68 years (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

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 Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: Single

Arms and Interventions

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

What is the study measuring?

Primary Outcome Measures

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

Secondary Outcome Measures

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

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Qilu Hospital of Shandong University

Investigators

  • Principal Investigator: enqi Zhao, master, Qilu Hospital of Shandong University

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

August 20, 2022

Primary Completion (Anticipated)

May 1, 2023

Study Completion (Anticipated)

May 1, 2023

Study Registration Dates

First Submitted

August 14, 2022

First Submitted That Met QC Criteria

September 19, 2022

First Posted (Actual)

September 22, 2022

Study Record Updates

Last Update Posted (Actual)

September 22, 2022

Last Update Submitted That Met QC Criteria

September 19, 2022

Last Verified

August 1, 2022

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • 2022038

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

No

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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