The Study of Skeletal Muscle Function in Obstructive Sleep Apnea

Obstructive Sleep Apnea Clinical Trial

Official title:

The Study of Skeletal Muscle Function in Obstructive Sleep Apnea

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT00813852
• Other study ID #: 200612106R
• Status: Completed
• Phase: N/A
• First received: December 21, 2008
• Last updated: June 14, 2012
• Start date: August 2007
• Est. completion date: July 2011

Study information

• Verified date: June 2012
• Source: National Taiwan University Hospital
• Contact: n/a
• Is FDA regulated: No
• Health authority: Taiwan: Department of Health
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 129
• Est. completion date: July 2011
• Est. primary completion date: July 2008
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: Male
• Age group: 40 Years to 65 Years

Eligibility

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.

Study Design

Allocation: Randomized, Endpoint Classification: Efficacy Study, Intervention Model: Parallel Assignment, Masking: Single Blind (Outcomes Assessor), Primary Purpose: Treatment

Related Conditions & MeSH terms

• Apnea
• Obstructive Sleep Apnea
• Sleep Apnea Syndromes
• Sleep Apnea, Obstructive

Intervention

Behavioral:
• exercise training, IMT
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.

Locations

Country	Name	City	State
Taiwan	National Taiwan University Hospital	Taipei

Sponsors (1)

Lead Sponsor	Collaborator
National Taiwan University Hospital

Country where clinical trial is conducted

Taiwan, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	strength, endurance, fatigability, and nerve conduction velocity in response to magnetic stimulation		4 months	No
Secondary	biochemistry markers, magnetic resonance spectroscopy		4 months	No