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出境医 / 临床实验 / Effects of Rehabilitation for Patients With Obstructive Sleep Apnea

Effects of Rehabilitation for Patients With Obstructive Sleep Apnea

Study Description
Brief Summary:
In previous review study, it was hypothesized that a comprehensive rehabilitation can combine both local pharyngeal muscle exercise and systemic cardiopulmonary rehabilitation for the OSA patients with oropharyngeal muscle dysfunction or ventilator drive instability. To develop a comprehensive rehabilitation model is of innovative care strategy in this study.

Condition or disease Intervention/treatment Phase
Obstructive Sleep Apnea of Adult Behavioral: comprehensive rehabilitation Not Applicable

Detailed Description:

BACKGROUND: Obstructive sleep apnea (OSA) is a prevalent sleep-related breathing disorder, which was characterized by repetitive events of complete and partial obstructions of the upper airway. The pathogenesis of OSA is interacted by multiple factors, primarily including upper airway (UA) anatomic impairment, ventilatory drive instability, and oropharyngeal muscle dysfunction. However, studies have proven prior oropharyngeal exercise was designed for those OSA patients with oropharyngeal muscle dysfunction. Unlike prior oropharyngeal exercise, comprehensive rehabilitation should emphasize the cardiorespiratory regulation capability in addition to oropharyngeal function.

OBJECTIVES: Therefore, the purpose of this study is to explore both the clinical and biological effects of our comprehensive rehabilitation, we used PSG data as clinical effect and biomarker of inflammation expression as biological effect.

METHODS: Thirty subjects with moderate or severe OSA (AHI≥15) were randomized into intervention group (N=15) and control group (N=15). In intervention group, a 12-week-intervention of out-patient rehabilitation program included oropharyngeal muscle training, threshold respiratory muscle training, and therapeutic exercise.

ANTICIPATED OUTCOMES: The preliminary results would demonstrate promisingly clinical effects and biological effects of our comprehensive rehabilitation model. Therefore, the further studies should emphasize the methods to differentiate diagnosis for the indicated patients with oropharyngeal muscle dysfunction or ventilatory drive instability.

Study Design
Layout table for study information
Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 33 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Intervention Model Description: 30 participants with moderate or severe OSA (AHI≥15) were randomized into intervention group (N=15) and control group (N=15).
Masking: Double (Participant, Outcomes Assessor)
Masking Description: participants and assessors blinded
Primary Purpose: Treatment
Official Title: Effects of Rehabilitation for Patients With Obstructive Sleep Apnea
Actual Study Start Date : September 1, 2017
Actual Primary Completion Date : February 28, 2019
Actual Study Completion Date : March 22, 2019
Arms and Interventions
Arm Intervention/treatment
Experimental: intervention group
We conducted a twice a week, 12-week-intervention of 'comprehensive rehabilitation'
 Behavioral: comprehensive rehabilitation
oropharyngeal rehabilitation, cardiopulmonary rehabilitation, and therapeutic exercise
No Intervention: control group
We kept the patients for the waiting list until after completing baseline and 12-week measurement
Outcome Measures
Primary Outcome Measures :
  1. Apnea-hypopea-index [ Time Frame: Change from Baseline Apnea-hypopnea-index at 12 weeks ]
    average apnea and hypopnea events per hour during sleep test

  2. potential biomarkers of endothelial dysfunction [ Time Frame: at 12 weeks ]
    count of ICAM-1, VCAM-1, and NF-κB molecule in plasma serum (%)


Secondary Outcome Measures :
  1. Oropharyngeal muscle function [ Time Frame: at 12 weeks ]
    myofunctional scale of genioglossus muscles, mastication muscles, and deglultition muscles

  2. Respiratory muscle function [ Time Frame: at 12 weeks ]
    PImax(mmH2O), PEmax(mmH2O)

  3. Respiratory muscle function [ Time Frame: at 12 weeks ]
    pulmonary function test (FVC%,FEV1%,FEF50%,FIF50%)

  4. Hear rate variability [ Time Frame: at 12 weeks ]
    time domain and frequency domain HRV


Eligibility Criteria
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Ages Eligible for Study:   35 Years to 65 Years   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  • Patients aged 35-65 with or without surgery had difficulty accepting or adhering CPAP

Exclusion Criteria:

  • BMI<32
  • Smoking or alcoholism
  • Severe allergic rhinitis
  • Stroke history
  • CVD
  • Severe restricted or obstructive pulmonary disease
  • Hypothyroidism
  • DM or HTN without stable control
  • Psychiatric disease
  • Co-existing non-respiratory sleep disorders
Contacts and Locations

Locations
Layout table for location information
Taiwan
National Cheng Kung University Hospital
Tainan, Taiwan, 704
Sponsors and Collaborators
National Cheng-Kung University Hospital
Investigators
Layout table for investigator information
Principal Investigator: Chinghsia Hung, PhD National Cheng-Kung University Hospital
Tracking Information
First Submitted Date  ICMJE January 10, 2019
First Posted Date  ICMJE May 7, 2019
Last Update Posted Date May 7, 2019
Actual Study Start Date  ICMJE September 1, 2017
Actual Primary Completion Date February 28, 2019   (Final data collection date for primary outcome measure)
Current Primary Outcome Measures  ICMJE
 (submitted: May 6, 2019)
  • Apnea-hypopea-index [ Time Frame: Change from Baseline Apnea-hypopnea-index at 12 weeks ]
    average apnea and hypopnea events per hour during sleep test
  • potential biomarkers of endothelial dysfunction [ Time Frame: at 12 weeks ]
    count of ICAM-1, VCAM-1, and NF-κB molecule in plasma serum (%)
Original Primary Outcome Measures  ICMJE Same as current
Change History No Changes Posted
Current Secondary Outcome Measures  ICMJE
 (submitted: May 6, 2019)
  • Oropharyngeal muscle function [ Time Frame: at 12 weeks ]
    myofunctional scale of genioglossus muscles, mastication muscles, and deglultition muscles
  • Respiratory muscle function [ Time Frame: at 12 weeks ]
    PImax(mmH2O), PEmax(mmH2O)
  • Respiratory muscle function [ Time Frame: at 12 weeks ]
    pulmonary function test (FVC%,FEV1%,FEF50%,FIF50%)
  • Hear rate variability [ Time Frame: at 12 weeks ]
    time domain and frequency domain HRV
Original Secondary Outcome Measures  ICMJE Same as current
Current Other Pre-specified Outcome Measures Not Provided
Original Other Pre-specified Outcome Measures Not Provided
 
Descriptive Information
Brief Title  ICMJE Effects of Rehabilitation for Patients With Obstructive Sleep Apnea
Official Title  ICMJE Effects of Rehabilitation for Patients With Obstructive Sleep Apnea
Brief Summary In previous review study, it was hypothesized that a comprehensive rehabilitation can combine both local pharyngeal muscle exercise and systemic cardiopulmonary rehabilitation for the OSA patients with oropharyngeal muscle dysfunction or ventilator drive instability. To develop a comprehensive rehabilitation model is of innovative care strategy in this study.
Detailed Description

BACKGROUND: Obstructive sleep apnea (OSA) is a prevalent sleep-related breathing disorder, which was characterized by repetitive events of complete and partial obstructions of the upper airway. The pathogenesis of OSA is interacted by multiple factors, primarily including upper airway (UA) anatomic impairment, ventilatory drive instability, and oropharyngeal muscle dysfunction. However, studies have proven prior oropharyngeal exercise was designed for those OSA patients with oropharyngeal muscle dysfunction. Unlike prior oropharyngeal exercise, comprehensive rehabilitation should emphasize the cardiorespiratory regulation capability in addition to oropharyngeal function.

OBJECTIVES: Therefore, the purpose of this study is to explore both the clinical and biological effects of our comprehensive rehabilitation, we used PSG data as clinical effect and biomarker of inflammation expression as biological effect.

METHODS: Thirty subjects with moderate or severe OSA (AHI≥15) were randomized into intervention group (N=15) and control group (N=15). In intervention group, a 12-week-intervention of out-patient rehabilitation program included oropharyngeal muscle training, threshold respiratory muscle training, and therapeutic exercise.

ANTICIPATED OUTCOMES: The preliminary results would demonstrate promisingly clinical effects and biological effects of our comprehensive rehabilitation model. Therefore, the further studies should emphasize the methods to differentiate diagnosis for the indicated patients with oropharyngeal muscle dysfunction or ventilatory drive instability.
Study Type  ICMJE Interventional
Study Phase  ICMJE Not Applicable
Study Design  ICMJE Allocation: Randomized
Intervention Model: Parallel Assignment
Intervention Model Description:
30 participants with moderate or severe OSA (AHI≥15) were randomized into intervention group (N=15) and control group (N=15).
Masking: Double (Participant, Outcomes Assessor)
Masking Description:
participants and assessors blinded
Primary Purpose: Treatment
Condition  ICMJE Obstructive Sleep Apnea of Adult
Intervention  ICMJE Behavioral: comprehensive rehabilitation
oropharyngeal rehabilitation, cardiopulmonary rehabilitation, and therapeutic exercise
Study Arms  ICMJE
  • Experimental: intervention group
    We conducted a twice a week, 12-week-intervention of 'comprehensive rehabilitation'
    Intervention: Behavioral: comprehensive rehabilitation
  • No Intervention: control group
    We kept the patients for the waiting list until after completing baseline and 12-week measurement
Publications * Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruitment Information
Recruitment Status  ICMJE Completed
Actual Enrollment  ICMJE
 (submitted: May 6, 2019) 		33
Original Actual Enrollment  ICMJE Same as current
Actual Study Completion Date  ICMJE March 22, 2019
Actual Primary Completion Date February 28, 2019   (Final data collection date for primary outcome measure)
Eligibility Criteria  ICMJE

Inclusion Criteria:

  • Patients aged 35-65 with or without surgery had difficulty accepting or adhering CPAP

Exclusion Criteria:

  • BMI<32
  • Smoking or alcoholism
  • Severe allergic rhinitis
  • Stroke history
  • CVD
  • Severe restricted or obstructive pulmonary disease
  • Hypothyroidism
  • DM or HTN without stable control
  • Psychiatric disease
  • Co-existing non-respiratory sleep disorders
Sex/Gender  ICMJE
Sexes Eligible for Study: All
Ages  ICMJE 35 Years to 65 Years   (Adult, Older Adult)
Accepts Healthy Volunteers  ICMJE No
Contacts  ICMJE Contact information is only displayed when the study is recruiting subjects
Listed Location Countries  ICMJE Taiwan
Removed Location Countries  
 
Administrative Information
NCT Number  ICMJE NCT03940781
Other Study ID Numbers  ICMJE NCKUH-10802018
Has Data Monitoring Committee No
U.S. FDA-regulated Product
Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
IPD Sharing Statement  ICMJE
Plan to Share IPD: No
Responsible Party Ching-Hsia Hung, National Cheng-Kung University Hospital
Study Sponsor  ICMJE National Cheng-Kung University Hospital
Collaborators  ICMJE Not Provided
Investigators  ICMJE
Principal Investigator: Chinghsia Hung, PhD National Cheng-Kung University Hospital
PRS Account National Cheng-Kung University Hospital
Verification Date May 2019

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP

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