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Completed

NCT Number: NCT02709941

Inspiratory Muscle Strength Training for Sleep-related Breathing Disorders

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.

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Key information

Conditions

Obstructive Sleep Apnea Apnea Dyssomnias Nervous System Diseases Respiration Disorders Respiratory Tract Diseases Sleep Apnea Syndromes Sleep Apnea, Obstructive Sleep Disorders, Intrinsic Sleep Wake Disorders

Age range

30 year–75 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Department of Physiology at the University of Arizona

Tucson, Arizona, 85721, United States

About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

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.

Other names: IMST

Placebo

Other

Primary outcomes

  1. Systolic and diastolic blood pressures (mmHg)

    Time frame: Weekly blood pressure measures obtained each week for 6 weeks

    Blood pressure measured with blood pressure cuff and syphygmomanometer via standard auscultation technique.

Secondary outcomes

  1. Apnea hypopnea index

    Time frame: 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.

  2. Sleep Quality Survey (PSQI)

    Time frame: 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.

  3. Plasma cathecholamines (epinephrine, norepinephrine and dopamine)

    Time frame: 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.

Sponsors and collaborators

Lead sponsor

University of Arizona

Other

Collaborators

  • American Heart Association

Registry information

Official study title

Respiratory Strength Training Mitigates Hypertension and Sleep Fragmentation in Obstructive Sleep Apnea

Important dates

Study start
2016
Primary completion
2017
Study completion
2017
First posted
Mar 16, 2016
Registry last updated
Nov 29, 2017

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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