Inspiratory Muscle Strength Training for Sleep-related Breathing Disorders

University of Arizona

Status: Completed

Conditions: Obstructive Sleep Apnea

Treatments: Other: Inspiratory muscle strength training; Other: Placebo

Study type: Interventional

Funder types: Other

Identifiers

NCT02709941

16GRNT26700007

Details and patient eligibility

About

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.

Full description

Aims of the study:

To determine the influence of IMST on resting blood pressure and baroreceptor sensitivity. 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.

Enrollment: 25 patients

Sex: All

Ages: 30 to 75 years old

Volunteers: No Healthy Volunteers

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

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Double Blind

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25 participants in 2 patient groups, including a placebo group

IMST Training Group

Active Comparator group

Description:

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.

Treatment:

Other: Inspiratory muscle strength training

Placebo Training Group

Placebo Comparator group

Description:

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.

Treatment:

Other: Placebo