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| Name | Class |
|---|---|
| American Heart Association | OTHER |
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The purpose of the current study is to investigate the effects of a novel breathing training, called inspiratory muscle strength training (IMST), on sleep patterns, breathing and blood pressure for patients diagnosed with mild, moderate and severe sleep apnea.
Aims of the study:
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- and post-training assessment include blood pressure measurement, body weight, neck circumference, cardiorespiratory monitoring, nerve recording, blood draw and sleep surveys.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| IMST Training Group | Active Comparator | 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. |
|
| Placebo Training Group | Placebo Comparator | 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. |
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| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Inspiratory muscle strength training | Other | Breathing training designed to augment inspiratory muscle strength, and thus targeted muscle groups may benefit from improved force generating capability result in improved breathing. |
| Measure | Description | Time Frame |
|---|---|---|
| Systolic and diastolic blood pressures (mmHg) | Blood pressure measured with blood pressure cuff and syphygmomanometer via standard auscultation technique. | Weekly blood pressure measures obtained each week for 6 weeks |
| Measure | Description | Time Frame |
|---|---|---|
| Apnea hypopnea index | Documentation of the total number of apneas and hypopneas experienced by the individuals per hour of sleep and expressed as the apnea-hypopnea index or AHI which has the following ranges; <5 normal; 5-15 mild, 15-30 moderate and >30 severe AHI. | Prior to and upon completion of the 6-weeks respiratory strength training. |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| E. Fiona Bailey, Ph.D. | University of Arizona | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Department of Physiology at the University of Arizona | Tucson | Arizona | 85721 | United States |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 26112283 | Background | 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. | |
| 22785143 | Background | 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. |
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| ID | Term |
|---|---|
| D020181 | Sleep Apnea, Obstructive |
| ID | Term |
|---|---|
| D012891 | Sleep Apnea Syndromes |
| D001049 | Apnea |
| D012120 | Respiration Disorders |
| D012140 | Respiratory Tract Diseases |
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the subjects were randomly allocated to either the sham training group or the inspiratory muscle training group using randomization lists for 4 strata (male/female X young/old)
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| Placebo | Other |
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| Sleep Quality Survey (PSQI) | This is a rating scale of overall sleep quality ranging from 0-21 with values <5 rated as indicative of normal or good sleep quality and a score of 21 indicative of most severe sleep disturbance. | Prior to and upon completion of the 6-weeks training. |
| Plasma cathecholamines (epinephrine, norepinephrine and dopamine) | Plasma catecholamines are determined via morning blood draw taken after 20 minutes supine rest. Reference ranges for plasma catecholamines are as follows: plasma epinephrine is 10-200 pg/ml; plasma norepinephrine 80-250 pg/ml and plasma dopamine 0-20 pg/ml. | Blood draw taken prior to and upon completion of the 6-weeks respiratory strength training. |
| 9488213 | Background | 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. |
| 32730174 | Derived | 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. |
| D020919 |
| Sleep Disorders, Intrinsic |
| D020920 | Dyssomnias |
| D012893 | Sleep Wake Disorders |
| D009422 | Nervous System Diseases |