Obstructive Sleep ApneaNCT02502942
Effects of Upper Airway Muscle Training on OSA
A study testing Upper Airway Muscle Exercise in people with Obstructive Sleep Apnea, run by University of California, San Diego at 1 site in United States.
Trial summary
Obstructive sleep apnea (OSA) is a common disorder characterized by recurrent collapse of the upper airway during sleep. OSA patients have a small upper airway that is kept patent during wakefulness by a compensatory increase in upper airway (UA) dilator muscle (e.g. genioglossus) activity. Read more about this study
- Who is it for?
- Ages 18 to 79 years
- Conditions the study is for
- Obstructive Sleep Apnea
- What is being tested?
- Upper Airway Muscle Exercise
- Type of treatment
- Pill or oral medicine, Lifestyle or therapy programme
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 134 participants
- Where
- 1 siteUnited States
- Study dates
- Aug 2015to 24 Jun 2019
- 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 79 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Prior diagnosis of OSA with AHI>10 events/hr.
- PAP group: subjects who have been on PAP treatment for at least 3 month, with good compliance (at least 4 hours a day and use PAP for >70% of the time).
- Untreated group: untreated subjects with generally mild OSA as defined by AHI<20 events/hr and nadir SaO2>70%. Additionally, investigators will also recruit OSA subjects of all severities who have previously tried but are not currently using PAP.
- Oral appliance treatment group: subjects have residual AHI >10 events/hr with oral appliance therapy.
Who cannot join
- In those with untreated sleep apnea, severe sleepiness with current Epworth Sleepiness Scale (ESS) > 18 or history of motor vehicle accident due to obstructive sleep apnea
- Taking medications classified as a muscle relaxant
- Pregnant women.
- Psychiatric disorder, other than mild and controlled depression; e.g. schizophrenia, bipolar disorder, major depression, panic or anxiety disorders.
- Current smokers, alcohol (>3oz/day) or use of illicit drugs.
- More than 10 cups of beverages with caffeine (coffee, tea, soda/pop) per day.
Show all 12Show fewer
- Unstable cardiac disease (e.g. congestive heart failure)
- Pulmonary disease (apart from well controlled mild asthma and OSA)
- Systemic neuromuscular disease
- Other systemic disease that affects breathing (e.g. stroke) or those with expected survival < 1 year.
- Poor oral condition, including: active periodontal disease, loose or broken teeth, lack of eight teeth in each arch, active TMJ dysfunction
- Known allergy to oral appliance components
Trial locations and contacts
1 site in 1 country.
United States1 site
University of California, San Diego
San Diego, California, 92093
About this study
Official title: Effects of Upper Airway Muscle Training on Obstructive Sleep Apnea (OSA)
Obstructive sleep apnea (OSA) is a common disorder characterized by recurrent collapse of the upper airway during sleep. OSA patients have a small upper airway that is kept patent during wakefulness by a compensatory increase in upper airway (UA) dilator muscle (e.g. genioglossus) activity. At sleep onset this compensation is reduced or lost, resulting in upper airway narrowing or collapse. Previous studies of upper airway muscle training showed variable results on OSA, but so far there has not been any practical, long-term, systematic upper airway muscle training developed or studied as the treatment of OSA. In theory, strengthening the upper airway muscle with exercise training in theory helps maintain a patent airway during sleep. Therefore, investigators aim to test the hypothesis: 1) UA muscle training can improve sleep apnea in some patients with OSA, including those already receiving treatment with PAP or oral appliance therapy. 2) Muscle training is a viable therapy for a definable subset of OSA patients. Investigators hypothesize that patients with OSA who have mild or moderately compromised upper airway anatomy will benefit the most. 3)There will be a positive association between the changes in muscle function and improvement in OSA severity.
Read the detailed description
Obstructive sleep apnea (OSA) is a common disorder characterized by recurrent collapse of the upper airway during sleep, which leads to recurrent arousal and subsequent daytime sleepiness. The most commonly accepted reason for the initiation of obstructive respiratory events in OSA is that patients have a small upper airway that is kept patent during wakefulness by a compensatory increase in upper airway dilator muscle (e.g. genioglossus) activity. At sleep onset this compensation is reduced or lost, resulting in upper airway narrowing or collapse.
Upper airway (UA) muscle training appears to have some benefit in OSA with improvement in the AHI, although the current data shows variable results, particularly when publication bias is taken into account. Many remain skeptical about these data based on clinical experience and prior negative studies (which remain largely unpublished). Moreover, previous positive studies involved exercises that are usually impractical to be continued in the long-term.
Therefore, investigators will undertake a rigorous assessment of a practical UA muscle training on OSA. Investigators will recruit patients with OSA that are wither unable/unwilling to use CPAP, as well as those who are already on treatment with PAP or oral appliances. The exercises include 4 steps: step 1 is to put on an individualized fitted oral retainer device to guide the exercise; step 2 is to push the tongue towards the hard palate to press the movable part of the oral retainer device for 4 minutes; step 3 is to touch the hard palate using the middle part of the tongue, hold for 10 seconds and repeat it for 4 minutes; step 4 is to remove the retainer device and brush the tongue gently on both sides for 2 minute. The exercise will take 20 minutes a day (10 minutes in the morning and 10 minutes in the afternoon/evening).
Investigators will study the effect of upper airway (UA) muscle training on OSA severity, muscle strengh and endurance. Investigators aim to determine the characteristics of OSA patients most likely to benefit from UA muscle training and the association between changes in muscle function and OSA severity.
- Conditions
- Obstructive Sleep Apnea
- Being tested
- Upper Airway Muscle Exercise, Sham Exercise
- Keywords
- Obstructive Sleep Apnea, Exercise, Upper airway muscle
- Medical subject headings
- Sleep Apnea, Obstructive, Motor Activity
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Upper Airway Muscle ExerciseBehavioural
Patients will use an individualized oral retainer device for upper airway muscle training exercises daily for 20 minutes each day (10 minutes in the morning and 10 minutes in the afternoon/evening) for 6 weeks.
Sham ExerciseBehavioural
Patients will be given an individualized oral retainer device and instructed to do deep breathing exercise twice daily for 6 weeks.
| Study group | Role | What they receive |
|---|---|---|
| Untreated OSA Muscle Exercise Group | Experimental | Patients who were previously diagnosed of obstructive sleep apnea (OSA) with apnea hypopnea index (AHI) > 10 events/hr and have previously failed or refused PAP therapy. In this group, patients will learn and practice upper airway muscle exercise for six weeks. Receives: Behavioral: Upper Airway Muscle Exercise |
| PAP Therapy Muscle Exercise Group | Experimental | OSA patients who are currently treated with PAP for their OSA (with AHI of previous sleep study > 10 events/hr). In this group, patients will learn and practice upper airway muscle exercise for six weeks. Receives: Behavioral: Upper Airway Muscle Exercise |
| Oral Appliance Muscle Exercise Group | Experimental | OSA patients who are currently treated with an oral appliance with residual AHI > 10 events/hr. In this group, patients will learn and practice upper airway muscle exercise for six weeks. Receives: Behavioral: Upper Airway Muscle Exercise |
| Normal Control Sham Exercise Group | Active comparator | Patients of untreated OSA group, PAP therapy group, and oral appliance group are randomized to upper airway muscle exercise versus sham exercise. Receives: Behavioral: Sham Exercise |
What is being measured
The primary outcome is the main question the study is designed to answer.
Change of severity of obstructive sleep apnea, measured as apnea hypopnea index (AHI), for untreated OSA group and oral appliance group
Home sleep test is used to measure AHI.
Measured: Baseline and after 6-week exercise training
Change of severity of obstructive sleep apnea, measured as 95th percentile pressures, for PAP therapy group
95th percentile pressures (2 week period) of autotitrating CPAP will be used to assess the effects of upper airway muscle exercise on muscle strength.
Measured: Baseline and after 6-week exercise training
Secondary outcomes (6)
Change of sleepiness measured by Epworth Sleepiness Scale (ESS)
ESS is a self-administered questionnaire with 8 questions. It provides a measure of a person's general level of daytime sleepiness, or their average sleep propensity in daily life.
Measured: Baseline and after 6-week exercise training
Change of sleep quality measured by Pittsburgh Sleep Quality Index (PSQI)
PSQI is a self-rated questionnaire which assesses sleep quality and disturbances over a 1-month time interval.
Measured: Baseline and after 6-week exercise training
Change of subjective quality of life measured by SF-36
SF-36 is a patient-reported survey of patient health status.
Measured: Baseline and after 6-week exercise training
Change of neurocognitive function measured by psychomotor vigilance test (PVT)
PVT is a sustained-attention, reaction-timed task that measures the speed with which subjects respond to a visual stimulus.
Measured: Baseline and after 6-week exercise training
Change of upper airway anatomy evaluated with acoustic pharyngometry
Acoustic pharyngometry is a non-invasive sonic measurement of the upper airway anatomy.
Measured: Baseline and after 6-week exercise training
Change of tongue strength and endurance evaluated with Iowa Oral Performance Instrument (IOPI)
IOPI is a hand held manometer which measures intraoral pressure generated by compression of an air filled bulb by the tongue against the palate.
Measured: Baseline and after 6-week exercise training
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted20 Jul 2015 (estimated)
- Study startAug 2015
- Primary completion24 Jun 2019
- Study completion24 Jun 2019
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 California, San DiegoThe 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
- Factorial
- Masking
- Single blind
- Who is masked
- Participant
- Enrolment
- 134 participants (actual)
Sponsor and investigators
- Lead sponsor
- University of California, San Diego
- Sponsor type
- University, hospital or other
- Collaborators
- National Institutes of Health (NIH), National Heart, Lung, and Blood Institute (NHLBI)
- Responsible party
- Principal investigator, Robert L. Owens, University of California, San Diego
- Investigators
- Atul Malhotra, MD, Principal investigator, University of California, San Diego
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02502942
- Sponsor's protocol ID
- UCSD130780
- Other IDs
- R01HL085188-05A1
- Status last verified
- Nov 2019
- First submitted
- 12 Jul 2015
- Last updated
- 27 Nov 2019
- Results posted
- No
- Data monitoring committee
- Yes
Study at a glance
From the registry record, last updated by the sponsor on 27 Nov 2019. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Effects of Upper Airway Muscle Training on Obstructive Sleep Apnea (OSA)
- ClinicalTrials.gov ID
- NCT02502942
- Acronym / sponsor ID
- UCSD130780
- Conditions
- Obstructive Sleep Apnea
- Keywords
- Obstructive Sleep Apnea, Exercise, Upper airway muscle
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 134 participants (actual)
- Lead sponsor
- University of California, San DiegoUniversity, hospital or other
- Collaborators
- National Institutes of Health (NIH), National Heart, Lung, and Blood Institute (NHLBI)
- Study start
- Aug 2015
- Primary completion
- 24 Jun 2019 (actual)
- Study completion
- 24 Jun 2019 (actual)
- First posted
- 20 Jul 2015 (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.
Obstructive sleep apnea (OSA) is a common disorder characterized by recurrent collapse of the upper airway during sleep. OSA patients have a small upper airway that is kept patent during wakefulness by a compensatory increase in upper airway (UA) dilator muscle (e.g. genioglossus) activity. At sleep onset this compensation is reduced or lost, resulting in upper airway narrowing or collapse. Previous studies of upper airway muscle training showed variable results on OSA, but so far there has not been any practical, long-term, systematic upper airway muscle training developed or studied as the treatment of OSA. In theory, strengthening the upper airway muscle with exercise training in theory helps maintain a patent airway during sleep. Therefore, investigators aim to test the hypothesis: 1) UA muscle training can improve sleep apnea in some patients with OSA, including those already receiving treatment with PAP or oral appliance therapy. 2) Muscle training is a viable therapy for a definable subset of OSA patients. Investigators hypothesize that patients with OSA who have mild or moderately compromised upper airway anatomy will benefit the most. 3)There will be a positive association between the changes in muscle function and improvement in OSA severity.
Detailed description
Obstructive sleep apnea (OSA) is a common disorder characterized by recurrent collapse of the upper airway during sleep, which leads to recurrent arousal and subsequent daytime sleepiness. The most commonly accepted reason for the initiation of obstructive respiratory events in OSA is that patients have a small upper airway that is kept patent during wakefulness by a compensatory increase in upper airway dilator muscle (e.g. genioglossus) activity. At sleep onset this compensation is reduced or lost, resulting in upper airway narrowing or collapse.
Upper airway (UA) muscle training appears to have some benefit in OSA with improvement in the AHI, although the current data shows variable results, particularly when publication bias is taken into account. Many remain skeptical about these data based on clinical experience and prior negative studies (which remain largely unpublished). Moreover, previous positive studies involved exercises that are usually impractical to be continued in the long-term.
Therefore, investigators will undertake a rigorous assessment of a practical UA muscle training on OSA. Investigators will recruit patients with OSA that are wither unable/unwilling to use CPAP, as well as those who are already on treatment with PAP or oral appliances. The exercises include 4 steps: step 1 is to put on an individualized fitted oral retainer device to guide the exercise; step 2 is to push the tongue towards the hard palate to press the movable part of the oral retainer device for 4 minutes; step 3 is to touch the hard palate using the middle part of the tongue, hold for 10 seconds and repeat it for 4 minutes; step 4 is to remove the retainer device and brush the tongue gently on both sides for 2 minute. The exercise will take 20 minutes a day (10 minutes in the morning and 10 minutes in the afternoon/evening).
Investigators will study the effect of upper airway (UA) muscle training on OSA severity, muscle strengh and endurance. Investigators aim to determine the characteristics of OSA patients most likely to benefit from UA muscle training and the association between changes in muscle function and OSA severity.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Factorial
- Masking
- Single blind (participant)
- Number of arms
- 4
| Arm | Type | Receives |
|---|---|---|
| Untreated OSA Muscle Exercise Group | Experimental | Behavioral: Upper Airway Muscle ExercisePatients who were previously diagnosed of obstructive sleep apnea (OSA) with apnea hypopnea index (AHI) > 10 events/hr and have previously failed or refused PAP therapy. In this group, patients will learn and practice upper airway muscle exercise for six weeks. |
| PAP Therapy Muscle Exercise Group | Experimental | Behavioral: Upper Airway Muscle ExerciseOSA patients who are currently treated with PAP for their OSA (with AHI of previous sleep study > 10 events/hr). In this group, patients will learn and practice upper airway muscle exercise for six weeks. |
| Oral Appliance Muscle Exercise Group | Experimental | Behavioral: Upper Airway Muscle ExerciseOSA patients who are currently treated with an oral appliance with residual AHI > 10 events/hr. In this group, patients will learn and practice upper airway muscle exercise for six weeks. |
| Normal Control Sham Exercise Group | Active comparator | Behavioral: Sham ExercisePatients of untreated OSA group, PAP therapy group, and oral appliance group are randomized to upper airway muscle exercise versus sham exercise. |
Who may qualify
- Ages
- 18 to 79 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (4 listed)
- Prior diagnosis of OSA with AHI>10 events/hr.
- PAP group: subjects who have been on PAP treatment for at least 3 month, with good compliance (at least 4 hours a day and use PAP for >70% of the time).
- Untreated group: untreated subjects with generally mild OSA as defined by AHI<20 events/hr and nadir SaO2>70%. Additionally, investigators will also recruit OSA subjects of all severities who have previously tried but are not currently using PAP.
- Oral appliance treatment group: subjects have residual AHI >10 events/hr with oral appliance therapy.
Key exclusion criteria (12 listed)
- In those with untreated sleep apnea, severe sleepiness with current Epworth Sleepiness Scale (ESS) > 18 or history of motor vehicle accident due to obstructive sleep apnea
- Taking medications classified as a muscle relaxant
- Pregnant women.
- Psychiatric disorder, other than mild and controlled depression; e.g. schizophrenia, bipolar disorder, major depression, panic or anxiety disorders.
- Current smokers, alcohol (>3oz/day) or use of illicit drugs.
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 |
|---|---|---|
| Upper Airway Muscle ExercisePatients will use an individualized oral retainer device for upper airway muscle training exercises daily for 20 minutes each day (10 minutes in the morning and 10 minutes in the afternoon/evening) for 6 weeks. | Behavioural | Oral Appliance Muscle Exercise Group, PAP Therapy Muscle Exercise Group, Untreated OSA Muscle Exercise Group |
| Sham ExercisePatients will be given an individualized oral retainer device and instructed to do deep breathing exercise twice daily for 6 weeks. | Behavioural | Normal Control Sham Exercise Group |
Primary outcome
Change of severity of obstructive sleep apnea, measured as apnea hypopnea index (AHI), for untreated OSA group and oral appliance group
Time frame: Baseline and after 6-week exercise training
Home sleep test is used to measure AHI.
Change of severity of obstructive sleep apnea, measured as 95th percentile pressures, for PAP therapy group
Time frame: Baseline and after 6-week exercise training
95th percentile pressures (2 week period) of autotitrating CPAP will be used to assess the effects of upper airway muscle exercise on muscle strength.
6 secondary outcomes
Change of sleepiness measured by Epworth Sleepiness Scale (ESS)
Time frame: Baseline and after 6-week exercise training
Change of sleep quality measured by Pittsburgh Sleep Quality Index (PSQI)
Time frame: Baseline and after 6-week exercise training
Change of subjective quality of life measured by SF-36
Time frame: Baseline and after 6-week exercise training
Change of neurocognitive function measured by psychomotor vigilance test (PVT)
Time frame: Baseline and after 6-week exercise training
Change of upper airway anatomy evaluated with acoustic pharyngometry
Time frame: Baseline and after 6-week exercise training
Change of tongue strength and endurance evaluated with Iowa Oral Performance Instrument (IOPI)
Time frame: Baseline and after 6-week exercise 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 27 Nov 2019.
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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.
Atul Malhotra, MD principal investigator
University of California, San Diego
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Upper Airway Muscle Exercise in people with Obstructive Sleep Apnea, run by University of California, San Diego 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 12 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 27 Nov 2019. 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. 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?
Change of severity of obstructive sleep apnea, measured as apnea hypopnea index (AHI), for untreated OSA group and oral appliance group (time frame: Baseline and after 6-week exercise training). The study lists 2 primary outcomes in all. 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 27 Nov 2019.