Obstructive Sleep ApneaOSANCT02259660
Airway Muscle Training for Obstructive Sleep Apnea
A study testing Respiratory muscle strength training in people with Obstructive Sleep Apnea, run by University of Florida at 1 site in United States.
Trial summary
The purpose of this research study is to determine if muscle training will improve snoring and obstructive sleep apnea. Subjects will receive a sleep study to determine the severity of their apnea. After this study, subjects will be randomly assigned to one of two groups. Read more about this study
- Who is it for?
- Ages 18 to 80 years
- Conditions the study is for
- Obstructive Sleep Apnea
- What is being tested?
- Respiratory muscle strength training
- Type of treatment
- Medical device
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 47 participants
- Where
- 1 siteUnited States
- Study dates
- Apr 2015to 28 Sep 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 18 to 80 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Age > 18 years,
- AHI ≥ 5/hour and less than 30/hour
- Ability to understand and perform training.
- Ability to return to the UFHealth Sleep Center 1X per week for the (8 week) duration of the study.
Who cannot join
- Pregnancy
- Prior Upper airway surgery (nasal surgery is allowed)
- Severe nasal obstruction
- BMI > 35 kg/M2
- Use of potent narcotics
- History of arrhythmia (other than PACs and PVCs)
Show all 11Show fewer
- Coronary artery disease or congestive heart failure (patients with controlled hypertension will be included),
- Moderate to severe lung disease
- History of pneumothorax.10. severe daytime sleepiness (falling asleep while driving or
- Epworth Sleepiness Scale [Appendix 1] > 14),
- History of chronic short sleep duration (< 5 hours).
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Upper Airway Muscle Training for Obstructive Sleep Apnea
The purpose of this research study is to determine if muscle training will improve snoring and obstructive sleep apnea. Subjects will receive a sleep study to determine the severity of their apnea. After this study, subjects will be randomly assigned to one of two groups. The first group will receiving a breathing trainer that may strengthen the muscles used to breath in and out. The second group will be receive a sham trainer which looks like the "real" trainer but is not able to produce a strengthening effect. Both groups will complete eight weeks of home based (real or sham) training. The sleep study will be repeated and we well measure any changes in measures of severity for obstructive sleep apnea.
Read the detailed description
Obstructive sleep apnea (OSA) is a common disorder characterized by intermittent narrowing or closure of the upper airway during sleep. Loss of muscle tone with sleep onset and decreases in ventilatory drive following the loss of the wakefulness stimuli to breathe combine to result in upper airway closure in patients with structurally susceptible upper airways. We hypothesize that training of upper airway muscles will improve sleep apnea by augmenting the resting upper airway muscle tone and ability of the muscles to respond to negative intraluminal pressure. Training with a primitive wind instrument (such as a Digeridoo) and oral pharyngeal exercises (OPE) used in speech therapy have been shown to improve sleep apnea. Individuals who play certain types of wind instruments appear to have a lower risk of sleep apnea. However, to date the mechanism of improvement and the optimal method of upper airway training have not been well defined. We recently completed a study with a facial exerciser (Facial Flex) designed to improve facial muscle tone and found a decrease in snoring in a group with loud snoring but minimal sleep apnea. A group of UF physiologists (including co investigators Drs. Davenport and Silverman) have also demonstrated that brief periods of training with high inspiratory and/or expiratory threshold loads improved cough and swallowing in patients with impairment in upper airway function. Although respiratory pump muscles provide the driving force for pressure generation during training with pressure threshold loads, the upper airway muscle must maintain a patent upper airway resisting high negative or positive intraluminal pressures. For example, the palate must maintain a seal preventing air escape through the nose when high positive pressure is generated through a mouthpiece. Of interest a limited number of very high intensity efforts appears to be the optimal way to train muscles.
We propose targeting a group of mild to moderate OSA patients (apnea-hypopnea index < 30/hour) who are not severely obese (BMI < 35 Kg/M2) and do not have significant structural abnormalities of the upper airway or muscle dysfunction. We will perform a randomized controlled trial (training versus sham training) with 25 subjects in each treatment arm using two months of daily training (5 out of 7 days each week). A home sleep study (including EEG) will be performed before and following the training. The change in the apnea-hypopnea index adjusted for sleep stage and body position will be compared. Use of home sleep studies will dramatically reduce the cost of the study. A sleep technologist will educate subjects on performance of maneuvers and meet with them weekly to observe the subject's technique. A training log will be kept by the subjects using training schedule sheets and daily training will be monitored through weekly web-based communication with a study clinician.
- Conditions
- Obstructive Sleep Apnea
- Being tested
- Respiratory muscle strength training, Sham respiratory muscle strength training
- Keywords
- obstructive sleep apnea, osa, breathing, snoring, respiratory, exercise, inspiratory muscle strength training, expiratory muscle strength training
- Medical subject headings
- Sleep Apnea, Obstructive, Respiratory Aspiration, Snoring, Motor Activity
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Respiratory muscle strength trainingDevice
Also called Inspiratory muscle strength training, Expiratory muscle strength training
Inspiratory and expiratory muscle strength training occur when subjects are required to breath in (as with inspiratory training) or out (as with expiratory training) through a pressure threshold device. This device features a spring-loaded one way valve which will only open if the subject is able to generate sufficient air pressure to overcome a predetermined pressure threshold. This threshold is typically set at 75% of the subject's maximum capacity. Repeatedly overcoming this threshold during training produces a strengthening effect in most people.
Sham respiratory muscle strength trainingDevice
Also called Sham inspiratory muscle strength training, Sham expiratory muscle strength training
The placebo / sham intervention will mimic the active intervention(s) in every respect except the devices used will be rendered neutral via removal of the pressure threshold spring inside the devices.
| Study group | Role | What they receive |
|---|---|---|
| Active Group | Active comparator | Subjects in this arm will train their respiratory muscles at home. The training protocol will use progressively higher pressure threshold training valves to provide respiratory muscle strength training at a pressure threshold greater than 70% maximum inspiratory (MIP) and expiratory (MEP) pressures. The total daily training time should be 20 to 30 minutes in duration. Receives: Device: Respiratory muscle strength training |
| Sham Training | Placebo comparator | The intervention in the sham training arm will be identical in every way to that of the active arm with the exception of the trainer that is provided. Subjects in the sham training arm will have inspiratory and expiratory muscle strength trainers which have had the pressure threshold spring removed and are therefore unable to provide a load to the muscles being trained. Receives: Device: Sham respiratory muscle strength training |
What is being measured
The primary outcome is the main question the study is designed to answer.
Apnea Hypopnea Index (AHI)
The AHI is a measure of symptom severity for obstructive sleep apnea. Physiological data obtained during a sleep study is used to complete this measure.
Measured: Baseline and 10 weeks
Secondary outcomes (2)
Maximum inspiratory pressure (MIP)
MIP is an estimate of the strength of respiratory muscles that are used to inhale. Specifically, the diaphragm and external intercostals. This measure is obtained by having the subject inhale forcibly through a mouthpiece connected to a pressure manometer.
Measured: Baseline and 10 weeks
Maximum expiratory pressure (MEP)
MEP is an estimate of the strength of breathing muscles used for exhalation. Specifically, the abdominals and internal intercostals. MEP is obtained by having the subject exhale forcibly through a mouthpiece that is connected to a pressure manometer.
Measured: Baseline and 10 weeks
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted8 Oct 2014 (estimated)
- Study startApr 2015
- Primary completionSep 2017
- Study completion28 Sep 2017
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Obstructive Sleep ApneaStudies of the same condition, open and under way.
- More trials run by University of FloridaThe 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
- Masking
- Triple blind
- Who is masked
- Participant, Care provider, Outcomes assessor
- Enrolment
- 47 participants (actual)
Sponsor and investigators
- Lead sponsor
- University of Florida
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Richard Berry, M.D., Principal investigator, University of Florida
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02259660
- Sponsor's protocol ID
- IRB201400642
- Acronym
- OSA
- Status last verified
- Apr 2018
- First submitted
- 26 Sep 2014
- Last updated
- 11 Apr 2018
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Undecided
Study at a glance
From the registry record, last updated by the sponsor on 11 Apr 2018. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Upper Airway Muscle Training for Obstructive Sleep Apnea
- ClinicalTrials.gov ID
- NCT02259660
- Acronym / sponsor ID
- OSA / IRB201400642
- Conditions
- Obstructive Sleep Apnea
- Keywords
- obstructive sleep apnea, osa, breathing, snoring, respiratory, exercise, inspiratory muscle strength training, expiratory muscle strength training
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 47 participants (actual)
- Lead sponsor
- University of FloridaUniversity, hospital or other
- Study start
- Apr 2015 (actual)
- Primary completion
- Sep 2017 (actual)
- Study completion
- 28 Sep 2017 (actual)
- First posted
- 8 Oct 2014 (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 this research study is to determine if muscle training will improve snoring and obstructive sleep apnea. Subjects will receive a sleep study to determine the severity of their apnea. After this study, subjects will be randomly assigned to one of two groups. The first group will receiving a breathing trainer that may strengthen the muscles used to breath in and out. The second group will be receive a sham trainer which looks like the "real" trainer but is not able to produce a strengthening effect. Both groups will complete eight weeks of home based (real or sham) training. The sleep study will be repeated and we well measure any changes in measures of severity for obstructive sleep apnea.
Detailed description
Obstructive sleep apnea (OSA) is a common disorder characterized by intermittent narrowing or closure of the upper airway during sleep. Loss of muscle tone with sleep onset and decreases in ventilatory drive following the loss of the wakefulness stimuli to breathe combine to result in upper airway closure in patients with structurally susceptible upper airways. We hypothesize that training of upper airway muscles will improve sleep apnea by augmenting the resting upper airway muscle tone and ability of the muscles to respond to negative intraluminal pressure. Training with a primitive wind instrument (such as a Digeridoo) and oral pharyngeal exercises (OPE) used in speech therapy have been shown to improve sleep apnea. Individuals who play certain types of wind instruments appear to have a lower risk of sleep apnea. However, to date the mechanism of improvement and the optimal method of upper airway training have not been well defined. We recently completed a study with a facial exerciser (Facial Flex) designed to improve facial muscle tone and found a decrease in snoring in a group with loud snoring but minimal sleep apnea. A group of UF physiologists (including co investigators Drs. Davenport and Silverman) have also demonstrated that brief periods of training with high inspiratory and/or expiratory threshold loads improved cough and swallowing in patients with impairment in upper airway function. Although respiratory pump muscles provide the driving force for pressure generation during training with pressure threshold loads, the upper airway muscle must maintain a patent upper airway resisting high negative or positive intraluminal pressures. For example, the palate must maintain a seal preventing air escape through the nose when high positive pressure is generated through a mouthpiece. Of interest a limited number of very high intensity efforts appears to be the optimal way to train muscles.
We propose targeting a group of mild to moderate OSA patients (apnea-hypopnea index < 30/hour) who are not severely obese (BMI < 35 Kg/M2) and do not have significant structural abnormalities of the upper airway or muscle dysfunction. We will perform a randomized controlled trial (training versus sham training) with 25 subjects in each treatment arm using two months of daily training (5 out of 7 days each week). A home sleep study (including EEG) will be performed before and following the training. The change in the apnea-hypopnea index adjusted for sleep stage and body position will be compared. Use of home sleep studies will dramatically reduce the cost of the study. A sleep technologist will educate subjects on performance of maneuvers and meet with them weekly to observe the subject's technique. A training log will be kept by the subjects using training schedule sheets and daily training will be monitored through weekly web-based communication with a study clinician.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Triple blind (participant, care provider, outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Active Group | Active comparator | Device: Respiratory muscle strength trainingSubjects in this arm will train their respiratory muscles at home. The training protocol will use progressively higher pressure threshold training valves to provide respiratory muscle strength training at a pressure threshold greater than 70% maximum inspiratory (MIP) and expiratory (MEP) pressures. The total daily training time should be 20 to 30 minutes in duration. |
| Sham Training | Placebo comparator | Device: Sham respiratory muscle strength trainingThe intervention in the sham training arm will be identical in every way to that of the active arm with the exception of the trainer that is provided. Subjects in the sham training arm will have inspiratory and expiratory muscle strength trainers which have had the pressure threshold spring removed and are therefore unable to provide a load to the muscles being trained. |
Who may qualify
- Ages
- 18 to 80 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (4 listed)
- Age > 18 years,
- AHI ≥ 5/hour and less than 30/hour
- Ability to understand and perform training.
- Ability to return to the UFHealth Sleep Center 1X per week for the (8 week) duration of the study.
Key exclusion criteria (11 listed)
- Pregnancy
- Prior Upper airway surgery (nasal surgery is allowed)
- Severe nasal obstruction
- BMI > 35 kg/M2
- Use of potent narcotics
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 |
|---|---|---|
| Respiratory muscle strength trainingAlso: Inspiratory muscle strength training, Expiratory muscle strength trainingInspiratory and expiratory muscle strength training occur when subjects are required to breath in (as with inspiratory training) or out (as with expiratory training) through a pressure threshold device. This device features a spring-loaded one way valve which will only open if the subject is able to generate sufficient air pressure to overcome a predetermined pressure threshold. This threshold is typically set at 75% of the subject's maximum capacity. Repeatedly overcoming this threshold during training produces a strengthening effect in most people. | Device | Active Group |
| Sham respiratory muscle strength trainingAlso: Sham inspiratory muscle strength training, Sham expiratory muscle strength trainingThe placebo / sham intervention will mimic the active intervention(s) in every respect except the devices used will be rendered neutral via removal of the pressure threshold spring inside the devices. | Device | Sham Training |
Primary outcome
Apnea Hypopnea Index (AHI)
Time frame: Baseline and 10 weeks
The AHI is a measure of symptom severity for obstructive sleep apnea. Physiological data obtained during a sleep study is used to complete this measure.
2 secondary outcomes
Maximum inspiratory pressure (MIP)
Time frame: Baseline and 10 weeks
Maximum expiratory pressure (MEP)
Time frame: Baseline and 10 weeks
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 11 Apr 2018.
- Individual participant dataSharing planned: Undecided
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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.
Richard Berry, M.D. principal investigator
University of Florida
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Respiratory muscle strength training in people with Obstructive Sleep Apnea, run by University of Florida 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 4 inclusion and 11 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 11 Apr 2018. 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?
Apnea Hypopnea Index (AHI) (time frame: Baseline and 10 weeks). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
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 11 Apr 2018.