Obstructive Sleep Apnea
Conditions
Keywords
Obstructive Sleep Apnea, Inspiratory Muscle Strength Training, Baroreceptor Sensitivity, Blood Pressure
Brief summary
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.
Detailed description
Aims of the study: 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.
Interventions
Breathing training designed to augment inspiratory muscle strength, and thus targeted muscle groups may benefit from improved force generating capability result in improved breathing.
OTHERPlacebo
Sponsors
American Heart Association
University of Arizona
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
DOUBLE (Subject, Investigator)
Intervention model description
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)
Eligibility
Sex/Gender
ALL
Age
30 Years to 75 Years
Healthy volunteers
No
Inclusion criteria
* Age 30-75 years * Diagnosed with Obstructive Sleep Apnea with Apnea Hypopnea Index (AHI) \> 15 * Neck circumference \> 16 cm
Exclusion criteria
* Body mass index (BMI) \> 40kg/m2 * 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
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Systolic and diastolic blood pressures (mmHg) | Weekly blood pressure measures obtained each week for 6 weeks | Blood pressure measured with blood pressure cuff and syphygmomanometer via standard auscultation technique. |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Apnea hypopnea index | Prior to and upon completion of the 6-weeks respiratory strength training. | 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. |
| Sleep Quality Survey (PSQI) | Prior to and upon completion of the 6-weeks training. | 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. |
| Plasma cathecholamines (epinephrine, norepinephrine and dopamine) | Blood draw taken prior to and upon completion of the 6-weeks respiratory strength training. | 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. |
Countries
United States
Outcome results
None listed