Long-term Effect of High Flow Nasal Canula Therapy on Obstructive Sleep Apnea

NCT05549310 | Unknown

• 1 other identifier: 2022037
• Study Type: interventional
• Target: 186
• Locations: 1 country
• Sites: 1

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.

Conditions

Obstructive Sleep Apnea; High Flow Nasal Canula; Continuous Positive Airway Pressure Ventilation

Outcome Measures

Primary Outcomes (13)

• AHI

  The data of the patient's AHI will be collected to evaluate the change of the patient's sleep.

  Change from Baseline AHI data at 1 month and 6 months.

• Treatment failure rate

  The data of the patient's AHI will be collected to evaluate the change of the patient's device adaptation.

  about sixth month

• Good compliance rate

  refers to the replacement of patients during treatment to another group of respiratory support or patients give up treatment

  about sixth month

• mean apnea time

  The data of the patient's mean apnea time will be collected to evaluate the change of the patient's sleep.

  Change from Baseline mean apnea time data at 1 month and 6 months.

• longest apnea time

  The data of the patient's mean apnea time will be collected to evaluate the change of the patient's sleep.

  Change from Baseline longest apnea time data at 1 month and 6 months.

• Mean oxygen saturation

  The data of the patient's mean apnea time will be collected to evaluate the change of the patient's oxygen saturation.

  Change from Baseline Mean oxygen saturation data at 1 month and 6 months.

• minimum oxygen saturation

  The data will be collected to evaluate the change of the patient's oxygen saturation.

  Change from Baseline minimum oxygen saturation data at 1 month and 6 months.

• ODI

  The data will be collected to evaluate the change of the patient's oxygen saturation.

  Change from Baseline ODI data at 1 month and 6 months.

• oxygen saturation < 90 % cumulative timesaturation

  The data will be collected to evaluate the change of the patient's oxygen saturation.

  Change from Baseline oxygen saturation < 90 % cumulative timesaturation data at 1 month and 6 months.

• Gender

  general condition

  by experiment finished:about 1 year

• age

  general condition

  by experiment finished:about 1 year

• height

  general condition

  by experiment finished:about 1 year

• weight

  general condition

  by experiment finished:about 1 year

Secondary Outcomes (8)

• total sleep time

  Change from Baseline total sleep time data at 1 month and 6 months.

• REM time

  Change from Baseline REM time data at 1 month and 6 months.

• NREM time

  Change from Baseline NREM time data at 1 month and 6 months.

• sleep efficiency ( SE )

  Change from Baseline sleep efficiency ( SE ) data at 1 month and 6 months.

• awakening time

  Change from Baseline awakening time data at 1 month and 6 months.

Study Arms (2)

CPAP group

ACTIVE COMPARATOR

CPAP group : The first stage: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. 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. CPAP group continued to receive corresponding treatment for 6 months.

Device: CPAP

HFNC group

EXPERIMENTAL

HFNC group : The first stage:receiving HFNC treatment for 6 hours / night, for 1 month. Patients in the treatment group first use pressure titration, select the appropriate pressure after treatment. 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 continued to receive corresponding treatment for 6 months.

Device: high-flow nasal canula oxygen therapy

Interventions

CPAP DEVICE

At the beginning of the experiment we will choose the most suitable pressure and flow for the patient by titration，

CPAP group

high-flow nasal canula oxygen therapy DEVICE

At the beginning of the experiment we will choose the most suitable pressure and flow for the patient by titration，

HFNC group

Eligibility Criteria

• Age: 18 Years - 70 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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.

You may not qualify if:

• meet any one of these
• Patients who cannot tolerate non-invasive ventilator or transnasal high-flow oxygen therapy.
• Ongoing treatment may affect sleep, such as sedatives, hypnotics, muscle relaxants, etc.
• Hemodynamic instability;
• Severe respiratory diseases;

Sponsors & Collaborators

• Qilu Hospital of Shandong University: lead

Study Sites (1)

Qilu Hospital of Shandong University

Jinan, Shandong, 250012, China

RECRUITING

Related Publications (6)

• 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.

  PMID: 23910433 BACKGROUND

• 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.

  PMID: 31300334 BACKGROUND

• 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.

  PMID: 23513246 BACKGROUND

• 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.

  PMID: 32832300 BACKGROUND

• 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.

  PMID: 19952061 BACKGROUND

• 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.

  PMID: 34383275 RESULT

MeSH Terms

Conditions

Sleep Apnea, Obstructive

Condition Hierarchy (Ancestors)

Sleep Apnea Syndromes; Apnea; Respiration Disorders; Respiratory Tract Diseases; Sleep Disorders, Intrinsic; Dyssomnias; Sleep Wake Disorders; Nervous System Diseases

Study Officials

• Zhuo Han, master

  Qilu Hospital of Shandong University

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Dedong Ma, doctor

CONTACT

18560082806; ma@qiluhuxi.com

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Model Details: Subjects are divided into 2 groups:HFNC group and CPAP group

Study Record Dates

• First Submitted: August 14, 2022
• First Posted: September 22, 2022
• Study Start: August 22, 2022
• Primary Completion: May 1, 2024
• Study Completion: May 1, 2025
• Last Updated: September 22, 2022

Record last verified: 2022-07

Data Sharing

• IPD Sharing: Will not share

Locations

CN (1)