Inspiratory Muscle Strength Training for Sleep-related Breathing Disorders

November 27, 2017 updated by: E. Fiona Bailey,PhD, University of Arizona

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

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.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

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.

Study Type

Interventional

Enrollment (Actual)

25

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • United States
    • Arizona
      • Tucson, Arizona, United States, 85721
        • Department of Physiology at the University of Arizona

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

30 years to 75 years (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

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

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: Double

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Active Comparator: IMST Training Group
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.
Other: Inspiratory muscle strength training
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 Comparator: Placebo Training Group
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.
Other: Placebo

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
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.
Weekly blood pressure measures obtained each week for 6 weeks

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
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.
Prior to and upon completion of the 6-weeks respiratory strength training.
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.
Prior to and upon completion of the 6-weeks training.
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.
Blood draw taken prior to and upon completion of the 6-weeks respiratory strength training.

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

University of Arizona

Collaborators

American Heart Association

Investigators

  • Principal Investigator: E. Fiona Bailey, Ph.D., University of Arizona

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

March 1, 2016

Primary Completion (Actual)

October 1, 2017

Study Completion (Actual)

October 1, 2017

Study Registration Dates

First Submitted

March 2, 2016

First Submitted That Met QC Criteria

March 10, 2016

First Posted (Estimate)

March 16, 2016

Study Record Updates

Last Update Posted (Actual)

November 29, 2017

Last Update Submitted That Met QC Criteria

November 27, 2017

Last Verified

November 1, 2017

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • 16GRNT26700007

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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