Effects of Rehabilitation for Patients With Obstructive Sleep Apnea

Not Applicable

Completed

• Conditions: Obstructive Sleep Apnea of Adult
• Interventions: Behavioral: comprehensive rehabilitation

• Registration Number: NCT03940781
• Lead Sponsor: National Cheng-Kung University Hospital

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 Timeline

• Study Start: 2017-09-01
• Study First Submitted: 2019-01-10
• Primary Completion: 2019-02-28
• Study Completion: 2019-03-22
• Status Verified: 2019-05
• Study First Submitted QC: 2019-05-06
• Last Update Submitted: 2019-05-06
• Study First Posted: 2019-05-07
• Last Update Posted: 2019-05-07

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 33

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

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
intervention group	comprehensive rehabilitation	We conducted a twice a week, 12-week-intervention of 'comprehensive rehabilitation'

Primary Outcome Measures

Name	Time	Method
Apnea-hypopea-index	Change from Baseline Apnea-hypopnea-index at 12 weeks	average apnea and hypopnea events per hour during sleep test
potential biomarkers of endothelial dysfunction	at 12 weeks	count of ICAM-1, VCAM-1, and NF-κB molecule in plasma serum (%)

Secondary Outcome Measures

Name	Time	Method
Oropharyngeal muscle function	at 12 weeks	myofunctional scale of genioglossus muscles, mastication muscles, and deglultition muscles
Respiratory muscle function	at 12 weeks	pulmonary function test (FVC%,FEV1%,FEF50%,FIF50%)
Hear rate variability	at 12 weeks	time domain and frequency domain HRV

Trial Locations

Locations (1)

National Cheng Kung University Hospital; 🇨🇳 Tainan, Taiwan