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Clinical Trials/NCT03940781
NCT03940781
Completed
Not Applicable

Effects of Rehabilitation for Patients With Obstructive Sleep Apnea

National Cheng-Kung University Hospital1 site in 1 country33 target enrollmentSeptember 1, 2017

Overview

Phase
Not Applicable
Intervention
Not specified
Conditions
Obstructive Sleep Apnea of Adult
Sponsor
National Cheng-Kung University Hospital
Enrollment
33
Locations
1
Primary Endpoint
Apnea-hypopea-index
Status
Completed
Last Updated
6 years ago

Overview

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.

Registry
clinicaltrials.gov
Start Date
September 1, 2017
End Date
March 22, 2019
Last Updated
6 years ago
Study Type
Interventional
Study Design
Parallel
Sex
All

Investigators

Responsible Party
Principal Investigator
Principal Investigator

Ching-Hsia Hung

Department chairman of physical therapy, College of Medicine, National Cheng Kung University

National Cheng-Kung University Hospital

Eligibility Criteria

Inclusion Criteria

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

Exclusion Criteria

  • Smoking or alcoholism
  • Severe allergic rhinitis
  • Stroke history
  • Severe restricted or obstructive pulmonary disease
  • Hypothyroidism
  • DM or HTN without stable control
  • Psychiatric disease
  • Co-existing non-respiratory sleep disorders

Outcomes

Primary Outcomes

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 (%)

Secondary Outcomes

  • Hear rate variability(at 12 weeks)
  • Oropharyngeal muscle function(at 12 weeks)
  • Respiratory muscle function(at 12 weeks)

Study Sites (1)

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