Inspiratory Muscle Strength Training for Sleep-related Breathing Disorders

NCT02709941 | Completed DMC

• 1 other identifier: 16GRNT26700007
• Study Type: interventional
• Target: 25
• Locations: 1 country
• Sites: 1

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.

Conditions

Obstructive Sleep Apnea

Keywords

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

Outcome Measures

Primary Outcomes (1)

• Systolic and diastolic blood pressures (mmHg)

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

  Weekly blood pressure measures obtained each week for 6 weeks

Secondary Outcomes (3)

• Apnea hypopnea index

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

• Sleep Quality Survey (PSQI)

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

• Plasma cathecholamines (epinephrine, norepinephrine and dopamine)

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

Study Arms (2)

IMST Training Group

ACTIVE COMPARATOR

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

Placebo Training Group

PLACEBO COMPARATOR

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

Interventions

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.

Also known as: IMST

IMST Training Group

Placebo OTHER

Placebo Training Group

Eligibility Criteria

• Age: 30 Years - 75 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Age 30-75 years
• Diagnosed with Obstructive Sleep Apnea with Apnea Hypopnea Index (AHI) \> 15
• Neck circumference \> 16 cm

You may not qualify if:

• 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

Sponsors & Collaborators

• University of Arizona: lead
• American Heart Association: collaborator

Study Sites (1)

Department of Physiology at the University of Arizona

Tucson, Arizona, 85721, United States

Location

Related Publications (4)

• 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.

  PMID: 26112283 BACKGROUND

• 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.

  PMID: 22785143 BACKGROUND

• 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.

  PMID: 9488213 BACKGROUND

• 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.

  PMID: 32730174 DERIVED

MeSH Terms

Conditions

Sleep Apnea, Obstructive

Condition Hierarchy (Ancestors)

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

Study Officials

• E. Fiona Bailey, Ph.D.

  University of Arizona

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: DOUBLE
• Who Masked: PARTICIPANT, INVESTIGATOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Associate Professor

Model Details: 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)

Study Record Dates

• First Submitted: March 2, 2016
• First Posted: March 16, 2016
• Study Start: March 1, 2016
• Primary Completion: October 1, 2017
• Study Completion: October 1, 2017
• Last Updated: November 29, 2017

Record last verified: 2017-11

Locations

US (1)