Clinical trial NCT02709941: Inspiratory Muscle Strength Training for Sleep-related Breathing Disorders
Official title: Respiratory Strength Training Mitigates Hypertension and Sleep Fragmentation in Obstructive Sleep Apnea
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Obstructive Sleep Apnea
Keywords: Obstructive Sleep Apnea
Inspiratory Muscle Strength Training
Baroreceptor Sensitivity
Blood Pressure
Lead sponsor: University of Arizona
Sponsor class: OTHER
Collaborators: name: American Heart Association
First posted: 2016-03-16
Enrollment: 25
Sex: ALL
Minimum age (years): 30
Maximum age (years): 75
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
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)
Primary purpose: TREATMENT

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.

Eligibility criteria: 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

Primary outcomes:
measure: Systolic and diastolic blood pressures (mmHg)
timeFrame: Weekly blood pressure measures obtained each week for 6 weeks
Secondary outcomes:
measure: Apnea hypopnea index
timeFrame: Prior to and upon completion of the 6-weeks respiratory strength training.
measure: Sleep Quality Survey (PSQI)
timeFrame: Prior to and upon completion of the 6-weeks training.
measure: Plasma cathecholamines (epinephrine, norepinephrine and dopamine)
timeFrame: Blood draw taken prior to and upon completion of the 6-weeks respiratory strength training.
Other outcomes:
Locations:
city: Tucson
country: United States
facility: Department of Physiology at the University of Arizona
state: Arizona
Study officials:
affiliation: University of Arizona
name: E. Fiona Bailey, Ph.D.
role: PRINCIPAL_INVESTIGATOR
References:
citation: 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.
citation: 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.
citation: 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.
citation: 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.