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

NCT ID: NCT05549245

Last Updated: 2022-09-22

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

UNKNOWN

Clinical Phase

NA

Total Enrollment

194 participants

Study Classification

INTERVENTIONAL

Study Start Date

2022-08-20

Study Completion Date

2023-05-31

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.

Detailed Description

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Conditions

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Obstructive Sleep Apnea

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

TREATMENT

Blinding Strategy

SINGLE

Outcome Assessors

Study Groups

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High-flow Nasal Cannula Oxygen Therapy group

Group Type EXPERIMENTAL

high-flow nasal cannula oxygen therapy,

Intervention Type DEVICE

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

Continues Positive Airway Pressure group

Group Type OTHER

CPAP

Intervention Type DEVICE

Patients were treated with CPAP for three nights

Interventions

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high-flow nasal cannula oxygen therapy,

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

Intervention Type DEVICE

CPAP

Patients were treated with CPAP for three nights

Intervention Type DEVICE

Eligibility Criteria

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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.
Minimum Eligible Age

18 Years

Maximum Eligible Age

70 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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Qilu Hospital of Shandong University

OTHER

Sponsor Role lead

Responsible Party

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Responsibility Role SPONSOR

Principal Investigators

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enqi Zhao, master

Role: PRINCIPAL_INVESTIGATOR

Qilu Hospital of Shandong University

Locations

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Qilu Hospital of Shandong University

Jinan, Shandong, China

Site Status RECRUITING

Countries

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China

Central Contacts

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Dedong Ma, doctor

Role: CONTACT

18560082806

Facility Contacts

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Dedong Ma, Doctor

Role: primary

18560082806

Enqi Zhao, doctor

Role: backup

15550834269

References

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Jordan AS, McSharry DG, Malhotra A. Adult obstructive sleep apnoea. Lancet. 2014 Feb 22;383(9918):736-47. doi: 10.1016/S0140-6736(13)60734-5. Epub 2013 Aug 2.

Reference Type BACKGROUND
PMID: 23910433 (View on PubMed)

Benjafield AV, Ayas NT, Eastwood PR, Heinzer R, Ip MSM, Morrell MJ, Nunez CM, Patel SR, Penzel T, Pepin JL, Peppard PE, Sinha S, Tufik S, Valentine K, Malhotra A. Estimation of the global prevalence and burden of obstructive sleep apnoea: a literature-based analysis. Lancet Respir Med. 2019 Aug;7(8):687-698. doi: 10.1016/S2213-2600(19)30198-5. Epub 2019 Jul 9.

Reference Type BACKGROUND
PMID: 31300334 (View on PubMed)

Parke RL, McGuinness SP. Pressures delivered by nasal high flow oxygen during all phases of the respiratory cycle. Respir Care. 2013 Oct;58(10):1621-4. doi: 10.4187/respcare.02358. Epub 2013 Mar 19.

Reference Type BACKGROUND
PMID: 23513246 (View on PubMed)

Nakanishi N, Suzuki Y, Ishihara M, Ueno Y, Tane N, Tsunano Y, Itagaki T, Oto J. Effect of High-Flow Nasal Cannula on Sleep-disordered Breathing and Sleep Quality in Patients With Acute Stroke. Cureus. 2020 Jul 20;12(7):e9303. doi: 10.7759/cureus.9303.

Reference Type BACKGROUND
PMID: 32832300 (View on PubMed)

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.

Reference Type BACKGROUND
PMID: 34383275 (View on PubMed)

Nilius G, Wessendorf T, Maurer J, Stoohs R, Patil SP, Schubert N, Schneider H. Predictors for treating obstructive sleep apnea with an open nasal cannula system (transnasal insufflation). Chest. 2010 Mar;137(3):521-8. doi: 10.1378/chest.09-0357. Epub 2009 Dec 1.

Reference Type BACKGROUND
PMID: 19952061 (View on PubMed)

Other Identifiers

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2022038

Identifier Type: -

Identifier Source: org_study_id

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