Effects of Rehabilitation for Patients With Obstructive Sleep Apnea

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.

Study Overview

• Status: Completed
• Conditions: Obstructive Sleep Apnea of Adult
• Intervention / Treatment: Behavioral: comprehensive rehabilitation

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 Type: Interventional
• Enrollment (Actual): 33
• Phase: Not Applicable

Contacts and Locations

Study Locations

• Taiwan
  • Tainan, Taiwan, 704
    • National Cheng Kung University Hospital

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 35 years to 65 years (Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

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 Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: Double

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: intervention group; We conducted a twice a week, 12-week-intervention of 'comprehensive rehabilitation'	Behavioral: comprehensive rehabilitation; oropharyngeal rehabilitation, cardiopulmonary rehabilitation, and therapeutic exercise
No Intervention: control group; We kept the patients for the waiting list until after completing baseline and 12-week measurement

What is the study measuring?

Primary Outcome Measures

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

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Oropharyngeal muscle function	myofunctional scale of genioglossus muscles, mastication muscles, and deglultition muscles	at 12 weeks
Respiratory muscle function	PImax(mmH2O), PEmax(mmH2O)	at 12 weeks
Respiratory muscle function	pulmonary function test (FVC%,FEV1%,FEF50%,FIF50%)	at 12 weeks
Hear rate variability	time domain and frequency domain HRV	at 12 weeks

Collaborators and Investigators

• Sponsor: National Cheng-Kung University Hospital
• Investigators: Principal Investigator: Chinghsia Hung, PhD, National Cheng-Kung University Hospital

Study record dates

Study Major Dates

• Study Start (Actual): September 1, 2017
• Primary Completion (Actual): February 28, 2019
• Study Completion (Actual): March 22, 2019

Study Registration Dates

• First Submitted: January 10, 2019
• First Submitted That Met QC Criteria: May 6, 2019
• First Posted (Actual): May 7, 2019

Study Record Updates

• Last Update Posted (Actual): May 7, 2019
• Last Update Submitted That Met QC Criteria: May 6, 2019
• Last Verified: May 1, 2019

More Information

Terms related to this study

• Keywords: obstructive sleep apnea; cardiopulmonary rehabilitation; oropharyngeal rehabilitation
• Additional Relevant MeSH Terms: Nervous System Diseases; Respiratory Tract Diseases; Respiration Disorders; Sleep Disorders, Intrinsic; Dyssomnias; Sleep Wake Disorders; Signs and Symptoms, Respiratory; Sleep Apnea Syndromes; Sleep Apnea, Obstructive; Apnea
• Other Study ID Numbers: NCKUH-10802018

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No