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The Study of Skeletal Muscle Function in Obstructive Sleep Apnea

Primary Purpose

Obstructive Sleep Apnea

Status
Completed
Phase
Not Applicable
Locations
Taiwan
Study Type
Interventional
Intervention
exercise training, IMT
Sponsored by
National Taiwan University Hospital
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Obstructive Sleep Apnea focused on measuring obstructive sleep apnea, skeletal muscle, magnetic stimulation, magnetic resonance spectroscopy, inflammatory markers, exercise

Eligibility Criteria

40 Years - 65 Years (Adult, Older Adult)MaleAccepts Healthy Volunteers

Inclusion Criteria:

  • ages from 40-65 years men who first underwent polysomnography at the Sleep Research Center.

Exclusion Criteria:

  • Subjects who had active medical or nervous system diseases, abnormal pulmonary function, morbid obesity, diabetes managed with oral hypoglycemic agents, alcoholism (≥ 50 gm per day), or a recent infection.

Sites / Locations

  • National Taiwan University Hospital

Arms of the Study

Arm 1

Arm Type

Experimental

Arm Label

2

Arm Description

exercise training, CPAP, and inspiratory muscle strengthening program

Outcomes

Primary Outcome Measures

strength, endurance, fatigability, and nerve conduction velocity in response to magnetic stimulation

Secondary Outcome Measures

biochemistry markers, magnetic resonance spectroscopy

Full Information

First Posted
December 21, 2008
Last Updated
June 14, 2012
Sponsor
National Taiwan University Hospital
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1. Study Identification

Unique Protocol Identification Number
NCT00813852
Brief Title
The Study of Skeletal Muscle Function in Obstructive Sleep Apnea
Official Title
The Study of Skeletal Muscle Function in Obstructive Sleep Apnea
Study Type
Interventional

2. Study Status

Record Verification Date
June 2012
Overall Recruitment Status
Completed
Study Start Date
August 2007 (undefined)
Primary Completion Date
July 2008 (Actual)
Study Completion Date
July 2011 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
National Taiwan University Hospital

4. Oversight

Data Monitoring Committee
No

5. Study Description

Brief Summary
The purposes of this study includes (1)to investigate inspiratory muscles and non-inspiratory muscle function in terms of strength, endurance, and fatigability in patients with obstructive sleep apnea (OSA), (2) investigate the metabolic characteristics of peripheral muscles and biochemistry markers in patients with OSA, and (3) to detect the effect of exercise training on the measured parameters in patients with OSA.
Detailed Description
It has become increasingly recognized that skeletal muscle abnormalities are common and profound in patients with chronic inflammatory status. Based on the unique character of obstructive sleep apnea (OSA), repeated intermittent apnea and hypopnea caused by the upper airway muscles collapse during inspiration, it is logical to speculate some adaptations in skeletal muscle of patients with OSA. The purpose of the first part is to investigate the inspiratory muscle function in patients with different severity of OSA. Participants firstly underwent polysomnography assessments will be recruited. The measurements includes Epworth sleepiness scale, strength and endurance of inspiratory muscles, and fatigue test during either maximal voluntary efforts or in response to cervical magnetic stimulation (CMS) with simultaneously sEMG recordings. In addition, the exercise capacity with simultaneous sEMG recordings for diaphragm and vastus lateralis during the exercise testing will also be tested. The second part is designed to examine the metabolic characteristics of lower extremity in patients with OSA. Blood samples will be drawn and proton magnetic resonance spectroscopy is used to detect intramyocellular and extramyocellular lipid contents (IMCL and EMCL). The third part will detect the effect of exercise training on the measured parameters described as above in patients with OSA. Participants will be randomized into exercise group, inspiratory muscle training group (IMT), and CPAP group. Exercise protocol includes 30-minute aerobic exercise at the intensity of 70%-85% VO2max, and 20-minute general resistance exercise. IMT group will receive inspiratory muscle strengthening by device.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Obstructive Sleep Apnea
Keywords
obstructive sleep apnea, skeletal muscle, magnetic stimulation, magnetic resonance spectroscopy, inflammatory markers, exercise

7. Study Design

Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
Outcomes Assessor
Allocation
Randomized
Enrollment
129 (Actual)

8. Arms, Groups, and Interventions

Arm Title
2
Arm Type
Experimental
Arm Description
exercise training, CPAP, and inspiratory muscle strengthening program
Intervention Type
Behavioral
Intervention Name(s)
exercise training, IMT
Other Intervention Name(s)
exercise
Intervention Description
Each exercise session includes graded treadmill walking and resisted exercises. The graded treadmill walking exercise begins with a 5 minute warm-up period with the intensity of about 40% of maximal oxygen consumption (VO2max) follows by a 30 minutes training phase. The training intensity is set at about 70%-85% of VO2max and ends with a 5-minute cool-down period with the intensity of about 40% of VO2max. The resisted exercise program includes 20 minutes of weight training with rest after the first 5 minutes.
Primary Outcome Measure Information:
Title
strength, endurance, fatigability, and nerve conduction velocity in response to magnetic stimulation
Time Frame
4 months
Secondary Outcome Measure Information:
Title
biochemistry markers, magnetic resonance spectroscopy
Time Frame
4 months

10. Eligibility

Sex
Male
Minimum Age & Unit of Time
40 Years
Maximum Age & Unit of Time
65 Years
Accepts Healthy Volunteers
Accepts Healthy Volunteers
Eligibility Criteria
Inclusion Criteria: ages from 40-65 years men who first underwent polysomnography at the Sleep Research Center. Exclusion Criteria: Subjects who had active medical or nervous system diseases, abnormal pulmonary function, morbid obesity, diabetes managed with oral hypoglycemic agents, alcoholism (≥ 50 gm per day), or a recent infection.
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Meng-Yueh Chien, PhD
Organizational Affiliation
National Taiwan University
Official's Role
Principal Investigator
Facility Information:
Facility Name
National Taiwan University Hospital
City
Taipei
ZIP/Postal Code
10051
Country
Taiwan

12. IPD Sharing Statement

Citations:
PubMed Identifier
32095087
Citation
Chien MY, Lee PL, Yu CW, Wei SY, Shih TT. Intramyocellular Lipids, Insulin Resistance, and Functional Performance in Patients with Severe Obstructive Sleep Apnea. Nat Sci Sleep. 2020 Jan 28;12:69-78. doi: 10.2147/NSS.S232554. eCollection 2020.
Results Reference
derived
PubMed Identifier
21706288
Citation
Chien MY, Lee P, Tsai YF, Yang PC, Wu YT. C-reactive protein and heart rate recovery in middle-aged men with severe obstructive sleep apnea. Sleep Breath. 2012 Sep;16(3):629-37. doi: 10.1007/s11325-011-0549-2. Epub 2011 Jun 27.
Results Reference
derived

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The Study of Skeletal Muscle Function in Obstructive Sleep Apnea

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