Inspiratory Muscle Strength Training for Sleep-related Breathing Disorders

Obstructive Sleep Apnea Clinical Trial

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT02709941
• Other study ID #: 16GRNT26700007
• Status: Completed
• Phase: N/A
• First received: March 2, 2016
• Last updated: November 27, 2017
• Start date: March 2016
• Est. completion date: October 2017

Study information

• Verified date: November 2017
• Source: University of Arizona
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 25
• Est. completion date: October 2017
• Est. primary completion date: October 2017
• Accepts healthy volunteers: No
• Gender: All
• Age group: 30 Years to 75 Years

Eligibility

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

Related Conditions & MeSH terms

• Apnea
• Obstructive Sleep Apnea
• Sleep Apnea Syndromes
• Sleep Apnea, Obstructive

Intervention

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.
• Placebo

Locations

Country	Name	City	State
United States	Department of Physiology at the University of Arizona	Tucson	Arizona

Sponsors (2)

Lead Sponsor	Collaborator
University of Arizona	American Heart Association

Country where clinical trial is conducted

United States, 

References & Publications (3)

Mello PR, Guerra GM, Borile S, Rondon MU, Alves MJ, Negrão 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. — View 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. — View 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. — View Citation

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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	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.	Prior to and upon completion of the 6-weeks respiratory strength training.
Secondary	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.	Prior to and upon completion of the 6-weeks training.
Secondary	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.	Blood draw taken prior to and upon completion of the 6-weeks respiratory strength training.