Clinical Trials Directory

Trials / Completed

CompletedNCT03940781

Effects of Rehabilitation for Patients With Obstructive Sleep Apnea

Status
Completed
Phase
N/A
Study type
Interventional
Enrollment
33 (actual)
Sponsor
National Cheng-Kung University Hospital · Academic / Other
Sex
All
Age
35 Years – 65 Years
Healthy volunteers
Not accepted

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.

Conditions

Interventions

TypeNameDescription
BEHAVIORALcomprehensive rehabilitationoropharyngeal rehabilitation, cardiopulmonary rehabilitation, and therapeutic exercise

Timeline

Start date
2017-09-01
Primary completion
2019-02-28
Completion
2019-03-22
First posted
2019-05-07
Last updated
2019-05-07

Locations

1 site across 1 country: Taiwan

Source: ClinicalTrials.gov record NCT03940781. Inclusion in this directory is not an endorsement.