Obstructive Sleep ApneaNCT00813852
The Study of Skeletal Muscle Function in Obstructive Sleep Apnea
A study testing exercise training, IMT in people with Obstructive Sleep Apnea, run by National Taiwan University Hospital at 1 site in Taiwan.
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… Read more about this study
- Who is it for?
- Ages 40 to 65 years, men onlyHealthy volunteers can take part
- Conditions the study is for
- Obstructive Sleep Apnea
- What is being tested?
- exercise training, IMT
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 129 participants
- Where
- 1 siteTaiwan
- Study dates
- Aug 2007to Jul 2011
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 40 to 65 years
- Men only
- Healthy volunteers accepted
- Adult, Older adult
Who may be able to join
- ages from 40-65 years men who first underwent polysomnography at the Sleep Research Center.
Who cannot join
- 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.
Trial locations and contacts
1 site in 1 country.
About this study
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.
Read the 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.
- Conditions
- Obstructive Sleep Apnea
- Being tested
- exercise training, IMT
- Keywords
- obstructive sleep apnea, skeletal muscle, magnetic stimulation, magnetic resonance spectroscopy, inflammatory markers, exercise
- Medical subject headings
- Sleep Apnea, Obstructive, Motor Activity
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
exercise training, IMTBehavioural
Also called exercise
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.
| Study group | Role | What they receive |
|---|---|---|
| 2 | Experimental | exercise training, CPAP, and inspiratory muscle strengthening program Receives: Behavioral: exercise training, IMT |
What is being measured
The primary outcome is the main question the study is designed to answer.
strength, endurance, fatigability, and nerve conduction velocity in response to magnetic stimulation
Measured: 4 months
Secondary outcomes (1)
biochemistry markers, magnetic resonance spectroscopy
Measured: 4 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted23 Dec 2008 (estimated)
- Study startAug 2007
- Primary completionJul 2008
- Study completionJul 2011
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (2)Papers the sponsor has linked to this study.
- Other trials for Obstructive Sleep ApneaStudies of the same condition, open and under way.
- More trials run by National Taiwan University HospitalThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind
- Who is masked
- Outcomes assessor
- Enrolment
- 129 participants (actual)
Sponsor and investigators
- Lead sponsor
- National Taiwan University Hospital
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, National Taiwan University Hospital, National Taiwan University Hospital
- Investigators
- Meng-Yueh Chien, PhD, Principal investigator, National Taiwan University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00813852
- Sponsor's protocol ID
- 200612106R
- Status last verified
- Jun 2012
- First submitted
- 21 Dec 2008
- Last updated
- 15 Jun 2012
- Results posted
- No
- Data monitoring committee
- No
Publications
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.
PubMed 32095087Chien 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.
PubMed 21706288
Study at a glance
From the registry record, last updated by the sponsor on 15 Jun 2012. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- The Study of Skeletal Muscle Function in Obstructive Sleep Apnea
- ClinicalTrials.gov ID
- NCT00813852
- Acronym / sponsor ID
- 200612106R
- Conditions
- Obstructive Sleep Apnea
- Keywords
- obstructive sleep apnea, skeletal muscle, magnetic stimulation, magnetic resonance spectroscopy, inflammatory markers, exercise
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 129 participants (actual)
- Lead sponsor
- National Taiwan University HospitalUniversity, hospital or other
- Study start
- Aug 2007
- Primary completion
- Jul 2008 (actual)
- Study completion
- Jul 2011 (actual)
- First posted
- 23 Dec 2008 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (outcomes assessor)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| 2 | Experimental | Behavioral: exercise training, IMTexercise training, CPAP, and inspiratory muscle strengthening program |
Who may qualify
- Ages
- 40 to 65 years
- Sex
- Male only
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (1 listed)
- ages from 40-65 years men who first underwent polysomnography at the Sleep Research Center.
Key exclusion criteria (1 listed)
- 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.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| exercise training, IMTAlso: exerciseEach 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. | Behavioural | 2 |
Primary outcome
strength, endurance, fatigability, and nerve conduction velocity in response to magnetic stimulation
Time frame: 4 months
1 secondary outcome
biochemistry markers, magnetic resonance spectroscopy
Time frame: 4 months
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 15 Jun 2012.
- Derived from this study: PubMed 32095087Chien 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.
- Derived from this study: PubMed 21706288Chien 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.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Meng-Yueh Chien, PhD principal investigator
National Taiwan University
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing exercise training, IMT in people with Obstructive Sleep Apnea, run by National Taiwan University Hospital at 1 site in Taiwan.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 1 inclusion and 1 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 15 Jun 2012. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Taiwan. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
strength, endurance, fatigability, and nerve conduction velocity in response to magnetic stimulation (time frame: 4 months). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT00813852, which also lists 2 linked publications.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 15 Jun 2012; AzTrials last refreshed its copy on 31 Oct 2026.