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Inspiratory Muscle Strength Training for Sleep-related Breathing Disorders

Primary Purpose

Obstructive Sleep Apnea

Status

Completed

Phase

Not Applicable

Locations

United States

Study Type

Interventional

Intervention

Inspiratory muscle strength training

Placebo

About this trial

This is an interventional treatment trial for Obstructive Sleep Apnea focused on measuring Obstructive Sleep Apnea, Inspiratory Muscle Strength Training, Baroreceptor Sensitivity, Blood Pressure

Eligibility Criteria

30 Years - 75 Years (Adult, Older Adult)All SexesDoes not accept 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

Sites / Locations

Department of Physiology at the University of Arizona

Arms of the Study

Arm 1

Arm 2

Arm Type

Active Comparator

Placebo Comparator

Arm Label

IMST Training Group

Placebo Training Group

Arm 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.

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.

Outcomes

Primary Outcome Measures

Systolic and diastolic blood pressures (mmHg)

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

Secondary Outcome Measures

Apnea hypopnea index

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.

Sleep Quality Survey (PSQI)

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.

Plasma cathecholamines (epinephrine, norepinephrine and dopamine)

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.

Full Information

NCT ID

NCT02709941

First Posted

March 2, 2016

Last Updated

November 27, 2017

Sponsor

University of Arizona

Collaborators

American Heart Association

1. Study Identification

Unique Protocol Identification Number

NCT02709941

Brief Title

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

2. Study Status

Record Verification Date

November 2017

Overall Recruitment Status

Completed

Study Start Date

March 2016 (undefined)

Primary Completion Date

October 2017 (Actual)

Study Completion Date

October 2017 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title

Principal Investigator

Name of the Sponsor

University of Arizona

Collaborators

American Heart Association

4. Oversight

Data Monitoring Committee

Yes

5. Study Description

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: 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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study

Obstructive Sleep Apnea

Keywords

Obstructive Sleep Apnea, Inspiratory Muscle Strength Training, Baroreceptor Sensitivity, Blood Pressure

7. Study Design

Primary Purpose

Treatment

Study Phase

Not Applicable

Interventional Study Model

Parallel Assignment

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)

Masking

ParticipantInvestigator

Allocation

Randomized

Enrollment

25 (Actual)

8. Arms, Groups, and Interventions

Arm Title

IMST Training Group

Arm Type

Active Comparator

Arm 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.

Arm Title

Placebo Training Group

Arm Type

Placebo Comparator

Arm 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.

Intervention Type

Other

Intervention Name(s)

Inspiratory muscle strength training

Other Intervention Name(s)

IMST

Intervention Description

Breathing training designed to augment inspiratory muscle strength, and thus targeted muscle groups may benefit from improved force generating capability result in improved breathing.

Intervention Type

Other

Intervention Name(s)

Placebo

Primary Outcome Measure Information:

Title

Systolic and diastolic blood pressures (mmHg)

Description

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

Time Frame

Weekly blood pressure measures obtained each week for 6 weeks

Secondary Outcome Measure Information:

Title

Apnea hypopnea index

Description

Time Frame

Prior to and upon completion of the 6-weeks respiratory strength training.

Title

Sleep Quality Survey (PSQI)

Description

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.

Time Frame

Prior to and upon completion of the 6-weeks training.

Title

Plasma cathecholamines (epinephrine, norepinephrine and dopamine)

Description

Time Frame

Blood draw taken prior to and upon completion of the 6-weeks respiratory strength training.

10. Eligibility

Sex

All

Minimum Age & Unit of Time

30 Years

Maximum Age & Unit of Time

75 Years

Accepts Healthy Volunteers

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

Overall Study Officials:

First Name & Middle Initial & Last Name & Degree

E. Fiona Bailey, Ph.D.

Organizational Affiliation

University of Arizona

Official's Role

Principal Investigator

Facility Information:

Facility Name

Department of Physiology at the University of Arizona

City

Tucson

State/Province

Arizona

ZIP/Postal Code

85721

Country

United States

12. IPD Sharing Statement

Citations:

PubMed Identifier

26112283

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.

Results Reference

background

PubMed Identifier

22785143

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.

Results Reference

background

PubMed Identifier

9488213

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.

Results Reference

background

PubMed Identifier

32730174

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. Erratum In: J Appl Physiol (1985). 2022 Jun 1;132(6):1591.

Results Reference

derived

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Inspiratory Muscle Strength Training for Sleep-related Breathing Disorders

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