Effects of Rehabilitation for Patients With Obstructive Sleep Apnea

NCT ID: NCT03940781

Last Updated: 2019-05-07

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: NA
• Total Enrollment: 33 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2017-09-01
• Study Completion Date: 2019-03-22

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.

Conditions

Obstructive Sleep Apnea of Adult

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: TREATMENT
• Blinding Strategy: DOUBLE

Study Groups

intervention group

We conducted a twice a week, 12-week-intervention of 'comprehensive rehabilitation'

Group Type: EXPERIMENTAL

comprehensive rehabilitation

Intervention Type: BEHAVIORAL

oropharyngeal rehabilitation, cardiopulmonary rehabilitation, and therapeutic exercise

control group

We kept the patients for the waiting list until after completing baseline and 12-week measurement

Group Type: NO_INTERVENTION

No interventions assigned to this group

Interventions

comprehensive rehabilitation

oropharyngeal rehabilitation, cardiopulmonary rehabilitation, and therapeutic exercise

Intervention Type: BEHAVIORAL

Eligibility 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

• Minimum Eligible Age: 35 Years
• Maximum Eligible Age: 65 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

National Cheng-Kung University Hospital

OTHER

Sponsor Role: lead

Responsible Party

Ching-Hsia Hung

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

Responsibility Role: PRINCIPAL_INVESTIGATOR

Principal Investigators

Chinghsia Hung, PhD

Role: PRINCIPAL_INVESTIGATOR

National Cheng-Kung University Hospital

Locations

National Cheng Kung University Hospital

Tainan City, , Taiwan

Countries

Taiwan

Other Identifiers

NCKUH-10802018

Identifier Type: -

Identifier Source: org_study_id