Inspiratory Muscle Strength Training for Sleep-related Breathing Disorders
NCT ID: NCT02709941
Last Updated: 2017-11-29
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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COMPLETED
NA
25 participants
INTERVENTIONAL
2016-03-31
2017-10-31
Brief Summary
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Detailed Description
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1. To determine the influence of IMST on resting blood pressure and baroreceptor sensitivity.
2. To determine the effect of IMST on sympathetic nervous system by measuring plasma cathecholamines and nerve recording (MSNA).
Population:
30 subjects aged 30-75 years, who have previously been diagnosed with obstructive sleep apnea, as defined by the National Institutes of Health (National Heart Lung, and Blood Institute) will be included in this study.
Study Protocol:
* Pre-training assessment and overnight sleep study
* 5-10 minutes each day breathing training (IMST) at home using a hand-held device for 6 weeks
* Once weekly laboratory visit
* Post-training assessment and overnight sleep study
Pre- and post-training assessment include blood pressure measurement, body weight, neck circumference, cardiorespiratory monitoring, nerve recording, blood draw and sleep surveys.
Conditions
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Keywords
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Study Design
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RANDOMIZED
PARALLEL
TREATMENT
DOUBLE
Study Groups
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IMST Training Group
Subjects in inspiratory muscle strength training group will complete 30 breaths against a resistance set at 75% of Maximal Inspiratory Pressure (PI Max) everyday for period of 6 weeks.
Inspiratory muscle strength training
Breathing training designed to augment inspiratory muscle strength, and thus targeted muscle groups may benefit from improved force generating capability result in improved breathing.
Placebo Training Group
Subjects in placebo training group will complete 30 breaths against a resistance set at 15% of Maximal Inspiratory Pressure (PI Max) everyday for period of 6 weeks.
Placebo
Interventions
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Inspiratory muscle strength training
Breathing training designed to augment inspiratory muscle strength, and thus targeted muscle groups may benefit from improved force generating capability result in improved breathing.
Placebo
Other Intervention Names
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Eligibility Criteria
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Inclusion Criteria
* Diagnosed with Obstructive Sleep Apnea with Apnea Hypopnea Index (AHI) \> 15
* Neck circumference \> 16 cm
Exclusion Criteria
* Implanted pacemaker
* On anticoagulant medication
* On hypnotic medication
* On immunosuppressive medication
* Acute or recent (3 months prior to study) infection
* History of hypothyroidism
* History of stroke or neuromuscular disease
* Moderate to severe heart failure
* Severe ischemic heart disease
* Severe obstructive and restrictive lung disease
* Cor pulmonale
* Cognitive disorders
* Obstructive nasal disease or history of spontaneous pneumothorax or rib fracture
* History of neurological, respiratory, head /neck, or thoracic surgery
30 Years
75 Years
ALL
No
Sponsors
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American Heart Association
OTHER
University of Arizona
OTHER
Responsible Party
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E. Fiona Bailey,PhD
Associate Professor
Principal Investigators
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E. Fiona Bailey, Ph.D.
Role: PRINCIPAL_INVESTIGATOR
University of Arizona
Locations
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Department of Physiology at the University of Arizona
Tucson, Arizona, United States
Countries
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References
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Vranish JR, Bailey EF. Daily respiratory training with large intrathoracic pressures, but not large lung volumes, lowers blood pressure in normotensive adults. Respir Physiol Neurobiol. 2015 Sep 15;216:63-9. doi: 10.1016/j.resp.2015.06.002. Epub 2015 Jun 22.
Mello PR, Guerra GM, Borile S, Rondon MU, Alves MJ, Negrao CE, Dal Lago P, Mostarda C, Irigoyen MC, Consolim-Colombo FM. Inspiratory muscle training reduces sympathetic nervous activity and improves inspiratory muscle weakness and quality of life in patients with chronic heart failure: a clinical trial. J Cardiopulm Rehabil Prev. 2012 Sep-Oct;32(5):255-61. doi: 10.1097/HCR.0b013e31825828da.
Parati G, Di Rienzo M, Bonsignore MR, Insalaco G, Marrone O, Castiglioni P, Bonsignore G, Mancia G. Autonomic cardiac regulation in obstructive sleep apnea syndrome: evidence from spontaneous baroreflex analysis during sleep. J Hypertens. 1997 Dec;15(12 Pt 2):1621-6. doi: 10.1097/00004872-199715120-00063.
Ramos-Barrera GE, DeLucia CM, Bailey EF. Inspiratory muscle strength training lowers blood pressure and sympathetic activity in older adults with OSA: a randomized controlled pilot trial. J Appl Physiol (1985). 2020 Sep 1;129(3):449-458. doi: 10.1152/japplphysiol.00024.2020. Epub 2020 Jul 30.
Other Identifiers
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16GRNT26700007
Identifier Type: -
Identifier Source: org_study_id