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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.

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Official record
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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.

United States1 site
  • UFHealth Sleep Center

    Gainesville, Florida, 32606

Other trials in United States

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.

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 groups in NCT02259660
Study groupRoleWhat they receive
Active GroupActive comparatorSubjects 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 TrainingPlacebo comparatorThe 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.

  1. 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)
  1. 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

  2. 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.

  1. First posted8 Oct 2014 (estimated)
  2. Study startApr 2015
  3. Primary completionSep 2017
  4. Study completion28 Sep 2017

Resources

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)
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

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.

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