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Effects of Upper Airway Muscle Training on OSA

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ClinicalTrials.gov Identifier: NCT02502942
Recruitment Status : Recruiting
First Posted : July 20, 2015
Last Update Posted : September 18, 2017
Sponsor:
Collaborators:
National Institutes of Health (NIH)
National Heart, Lung, and Blood Institute (NHLBI)
Information provided by (Responsible Party):
Robert L. Owens, University of California, San Diego

Brief 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. 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.

Condition or disease Intervention/treatment Phase
Obstructive Sleep Apnea Behavioral: Upper Airway Muscle Exercise Behavioral: Sham Exercise Not Applicable

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 Type : Interventional  (Clinical Trial)
Estimated Enrollment : 60 participants
Allocation: Randomized
Intervention Model: Factorial Assignment
Masking: Single (Participant)
Primary Purpose: Treatment
Official Title: Effects of Upper Airway Muscle Training on Obstructive Sleep Apnea (OSA)
Study Start Date : August 2015
Estimated Primary Completion Date : June 2018
Estimated Study Completion Date : June 2019

Resource links provided by the National Library of Medicine


Arm Intervention/treatment
Experimental: Untreated OSA Muscle Exercise Group
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.
Behavioral: Upper Airway Muscle Exercise
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.

Experimental: PAP Therapy Muscle Exercise Group
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.
Behavioral: Upper Airway Muscle Exercise
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.

Experimental: Oral Appliance Muscle Exercise Group
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.
Behavioral: Upper Airway Muscle Exercise
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.

Active Comparator: Normal Control Sham Exercise Group
Patients of untreated OSA group, PAP therapy group, and oral appliance group are randomized to upper airway muscle exercise versus sham exercise.
Behavioral: Sham Exercise
Patients will be given an individualized oral retainer device and instructed to do deep breathing exercise twice daily for 6 weeks.




Primary Outcome Measures :
  1. 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.

  2. 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.


Secondary Outcome Measures :
  1. Change of sleepiness measured by Epworth Sleepiness Scale (ESS) [ Time Frame: Baseline and after 6-week exercise training ]
    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.

  2. Change of sleep quality measured by Pittsburgh Sleep Quality Index (PSQI) [ Time Frame: Baseline and after 6-week exercise training ]
    PSQI is a self-rated questionnaire which assesses sleep quality and disturbances over a 1-month time interval.

  3. Change of subjective quality of life measured by SF-36 [ Time Frame: Baseline and after 6-week exercise training ]
    SF-36 is a patient-reported survey of patient health status.

  4. Change of neurocognitive function measured by psychomotor vigilance test (PVT) [ Time Frame: Baseline and after 6-week exercise training ]
    PVT is a sustained-attention, reaction-timed task that measures the speed with which subjects respond to a visual stimulus.

  5. Change of upper airway anatomy evaluated with acoustic pharyngometry [ Time Frame: Baseline and after 6-week exercise training ]
    Acoustic pharyngometry is a non-invasive sonic measurement of the upper airway anatomy.

  6. Change of tongue strength and endurance evaluated with Iowa Oral Performance Instrument (IOPI) [ Time Frame: Baseline and after 6-week exercise training ]
    IOPI is a hand held manometer which measures intraoral pressure generated by compression of an air filled bulb by the tongue against the palate.



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Ages Eligible for Study:   18 Years to 79 Years   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  • 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.

Exclusion Criteria:

  • 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.
  • 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

Information from the National Library of Medicine

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): NCT02502942


Contacts
Contact: Robert Owens, MD 619-471-9505 rowens@ucsd.edu
Contact: Pamela DeYoung (858) 246-2183 pdeyoung@ucsd.edu

Locations
United States, California
University of California, San Diego Recruiting
San Diego, California, United States, 92093
Contact: Pamela Deyoung    858-246-2183    pdeyoung@ucsd.edu   
Contact    858-246-2154      
Principal Investigator: Robert Owens, M.D.         
Sponsors and Collaborators
University of California, San Diego
National Institutes of Health (NIH)
National Heart, Lung, and Blood Institute (NHLBI)
Investigators
Principal Investigator: Atul Malhotra, MD University of California, San Diego

Responsible Party: Robert L. Owens, Assistant Professor, University of California, San Diego
ClinicalTrials.gov Identifier: NCT02502942     History of Changes
Other Study ID Numbers: UCSD130780
R01HL085188-05A1 ( U.S. NIH Grant/Contract )
First Posted: July 20, 2015    Key Record Dates
Last Update Posted: September 18, 2017
Last Verified: September 2017

Keywords provided by Robert L. Owens, University of California, San Diego:
Obstructive Sleep Apnea
Exercise
Upper airway muscle

Additional relevant MeSH terms:
Apnea
Sleep Apnea Syndromes
Sleep Apnea, Obstructive
Sleep Disorders, Intrinsic
Sleep Wake Disorders
Respiration Disorders
Respiratory Tract Diseases
Signs and Symptoms, Respiratory
Signs and Symptoms
Dyssomnias
Nervous System Diseases