Inspiratory Muscle Strength Training for Sleep-related Breathing Disorders

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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

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

Trial contacts and locations

1

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Data sourced from clinicaltrials.gov

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