Obstructive Sleep ApneaNCT02709941
Inspiratory Muscle Strength Training for Sleep-related Breathing Disorders
A study testing Inspiratory muscle strength training in people with Obstructive Sleep Apnea, run by University of Arizona at 1 site in United States.
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. Read more about this study
- Who is it for?
- Ages 30 to 75 years
- Conditions the study is for
- Obstructive Sleep Apnea
- What is being tested?
- Inspiratory muscle strength training
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 25 participants
- Where
- 1 siteUnited States
- Study dates
- Mar 2016to Oct 2017
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 30 to 75 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Age 30-75 years
- Diagnosed with Obstructive Sleep Apnea with Apnea Hypopnea Index (AHI) > 15
- Neck circumference > 16 cm
Who cannot join
- 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
Show all 15Show fewer
- 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
Trial locations and contacts
1 site in 1 country.
United States1 site
Department of Physiology at the University of Arizona
Tucson, Arizona, 85721
About this study
Official title: 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.
Read the 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.
- Conditions
- Obstructive Sleep Apnea
- Being tested
- Inspiratory muscle strength training, Placebo
- Keywords
- Obstructive Sleep Apnea, Inspiratory Muscle Strength Training, Baroreceptor Sensitivity, Blood Pressure
- Medical subject headings
- Sleep Apnea, Obstructive
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Inspiratory muscle strength trainingOther
Also called IMST
Breathing training designed to augment inspiratory muscle strength, and thus targeted muscle groups may benefit from improved force generating capability result in improved breathing.
PlaceboOther
| Study group | Role | What they receive |
|---|---|---|
| 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. Receives: 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. Receives: Other: Placebo |
What is being measured
The primary outcome is the main question the study is designed to answer.
Systolic and diastolic blood pressures (mmHg)
Blood pressure measured with blood pressure cuff and syphygmomanometer via standard auscultation technique.
Measured: Weekly blood pressure measures obtained each week for 6 weeks
Secondary outcomes (3)
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.
Measured: Prior to and upon completion of the 6-weeks respiratory strength training.
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.
Measured: Prior to and upon completion of the 6-weeks training.
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.
Measured: Blood draw taken prior to and upon completion of the 6-weeks respiratory strength training.
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted16 Mar 2016 (estimated)
- Study startMar 2016
- Primary completionOct 2017
- Study completionOct 2017
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (4)Papers the sponsor has linked to this study.
- Other trials for Obstructive Sleep ApneaStudies of the same condition, open and under way.
- More trials run by University of ArizonaThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- 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 blind
- Who is masked
- Participant, Investigator
- Enrolment
- 25 participants (actual)
Sponsor and investigators
- Lead sponsor
- University of Arizona
- Sponsor type
- University, hospital or other
- Collaborators
- American Heart Association
- Responsible party
- Principal investigator, E. Fiona Bailey,PhD, University of Arizona
- Investigators
- E. Fiona Bailey, Ph.D., Principal investigator, University of Arizona
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02709941
- Sponsor's protocol ID
- 16GRNT26700007
- Status last verified
- Nov 2017
- First submitted
- 2 Mar 2016
- Last updated
- 29 Nov 2017
- Results posted
- No
- Data monitoring committee
- Yes
Publications
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.
PubMed 26112283Mello 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.
PubMed 22785143Parati 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.
PubMed 9488213Ramos-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.
PubMed 32730174
Study at a glance
From the registry record, last updated by the sponsor on 29 Nov 2017. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Respiratory Strength Training Mitigates Hypertension and Sleep Fragmentation in Obstructive Sleep Apnea
- ClinicalTrials.gov ID
- NCT02709941
- Acronym / sponsor ID
- 16GRNT26700007
- Conditions
- Obstructive Sleep Apnea
- Keywords
- Obstructive Sleep Apnea, Inspiratory Muscle Strength Training, Baroreceptor Sensitivity, Blood Pressure
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 25 participants (actual)
- Lead sponsor
- University of ArizonaUniversity, hospital or other
- Collaborators
- American Heart Association
- Study start
- Mar 2016
- Primary completion
- Oct 2017 (actual)
- Study completion
- Oct 2017 (actual)
- First posted
- 16 Mar 2016 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind (participant, investigator)
- Number of arms
- 2
- 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)
| Arm | Type | Receives |
|---|---|---|
| IMST Training Group | Active comparator | Other: Inspiratory muscle strength trainingSubjects 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. |
| Placebo Training Group | Placebo comparator | Other: PlaceboSubjects 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. |
Who may qualify
- Ages
- 30 to 75 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (3 listed)
- Age 30-75 years
- Diagnosed with Obstructive Sleep Apnea with Apnea Hypopnea Index (AHI) > 15
- Neck circumference > 16 cm
Key exclusion criteria (15 listed)
- Body mass index (BMI) > 40kg/m2
- Implanted pacemaker
- On anticoagulant medication
- On hypnotic medication
- On immunosuppressive medication
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Inspiratory muscle strength trainingAlso: IMSTBreathing training designed to augment inspiratory muscle strength, and thus targeted muscle groups may benefit from improved force generating capability result in improved breathing. | Other | IMST Training Group |
| Placebo | Other | Placebo Training Group |
Primary outcome
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.
3 secondary outcomes
Apnea hypopnea index
Time frame: 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.
Plasma cathecholamines (epinephrine, norepinephrine and dopamine)
Time frame: Blood draw taken prior to and upon completion of the 6-weeks respiratory strength training.
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 29 Nov 2017.
- Background: PubMed 26112283Vranish 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.
- Background: PubMed 22785143Mello 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.
- Background: PubMed 9488213Parati 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.
- Derived from this study: PubMed 32730174Ramos-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.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
E. Fiona Bailey, Ph.D. principal investigator
University of Arizona
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Inspiratory muscle strength training in people with Obstructive Sleep Apnea, run by University of Arizona at 1 site in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 3 inclusion and 15 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 29 Nov 2017. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. Some participants in this study may receive a placebo. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Systolic and diastolic blood pressures (mmHg) (time frame: Weekly blood pressure measures obtained each week for 6 weeks). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT02709941, which also lists 4 linked publications.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 29 Nov 2017.