Effects of Rehabilitation for Patients With Obstructive Sleep Apnea

National Cheng-Kung University

Status: Completed

Conditions: Obstructive Sleep Apnea of Adult

Treatments: Behavioral: comprehensive rehabilitation

Study type: Interventional

Funder types: Other

Identifiers

NCT03940781

NCKUH-10802018

Details and patient eligibility

About

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.

Full 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.

Enrollment: 33 patients

Sex: All

Ages: 35 to 65 years old

Volunteers: No Healthy Volunteers

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

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Double Blind

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33 participants in 2 patient groups

intervention group

Experimental group

Description:

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

Treatment:

Behavioral: comprehensive rehabilitation

control group

No Intervention group

Description:

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