Inspiratory Muscle Strength Training for Sleep-related Breathing Disorders
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|ClinicalTrials.gov Identifier: NCT02709941|
Recruitment Status : Completed
First Posted : March 16, 2016
Last Update Posted : November 29, 2017
|Condition or disease||Intervention/treatment||Phase|
|Obstructive Sleep Apnea||Other: Inspiratory muscle strength training Other: Placebo||Not Applicable|
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).
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.
- 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 (Clinical Trial)|
|Actual Enrollment :||25 participants|
|Intervention Model:||Parallel Assignment|
|Intervention 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:||Double (Participant, Investigator)|
|Official Title:||Respiratory Strength Training Mitigates Hypertension and Sleep Fragmentation in Obstructive Sleep Apnea|
|Study Start Date :||March 2016|
|Actual Primary Completion Date :||October 2017|
|Actual Study Completion Date :||October 2017|
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 Name: 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.
- 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.
- 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.
- 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.
- 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.
To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT02709941
|United States, Arizona|
|Department of Physiology at the University of Arizona|
|Tucson, Arizona, United States, 85721|
|Principal Investigator:||E. Fiona Bailey, Ph.D.||University of Arizona|