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Effect of Myofunctional Therapy on OSA

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Know the risks and potential benefits of clinical studies and talk to your health care provider before participating. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT04608552
Recruitment Status : Recruiting
First Posted : October 29, 2020
Last Update Posted : February 18, 2022
Sponsor:
Information provided by (Responsible Party):
VA Office of Research and Development

Brief Summary:
The primary medical therapies for patients with Obstructive Sleep Apnea syndrome (OSA) require the use of medical devices on a nightly basis to help control breathing during sleep, which can be difficult for patients with mild-to-moderate disease. Because many patients use these therapies on a limited basis, or stop using them altogether, they continue to be at increased risk of the consequences of untreated OSA. Untreated and undertreated OSA compounds the risk of OSA consequences over time, particularly with increasing age and weight. Orofacial Myofunctional Therapy (OMT) takes a rehabilitative approach to OSA and is comprised of isotonic and isometric exercises that target the oral (e.g., tongue) and oropharyngeal (e.g., soft palate, lateral pharyngeal wall) to help restore normal breathing and airway patency at night while asleep. Should the study have positive findings, OMT could become an important alternative therapy for patients with mild-to-moderate disease because patients could utilize a therapy that improves their nighttime breathing through daytime exercises and without the need for a burdensome medical device.

Condition or disease Intervention/treatment Phase
Obstructive Sleep Apnea Behavioral: OMT Exercises Behavioral: Nasal Breathing Exercises Other: Use of Nasal Lavage Not Applicable

Detailed Description:
The purpose of this study is to examine the effect of Orofacial Myofunctional Therapy in Veterans with mild-to-moderate sleep apnea. The main question to be answered is whether OMT improves measures of OSA severity, patient functional status, and OSA symptoms when compared to sham OMT.

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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 240 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Single (Participant)
Primary Purpose: Supportive Care
Official Title: Effect of Myofunctional Therapy on Outcomes in Mild to Moderate Sleep Apnea
Actual Study Start Date : August 2, 2021
Estimated Primary Completion Date : March 31, 2024
Estimated Study Completion Date : September 30, 2024


Arm Intervention/treatment
Active Comparator: Active Myofunctional Therapy
Active Myofunctional Therapy is comprised of five 30-minute weekly sessions for 4 weeks.
Behavioral: OMT Exercises
Oral and oropharyngeal exercises

Sham Comparator: Inactive Myofunctional Therapy
Sham MT will be comprised of recommendations for five 30-minute nasal breathing exercises each week, use of nasal lavage with application of 10ml of saline in each nostril two times per day.
Behavioral: Nasal Breathing Exercises
Nasal breathing exercises each week

Other: Use of Nasal Lavage
Use of nasal lavage with application of 10ml of saline in each nostril two times per day




Primary Outcome Measures :
  1. Change in Apnea Hypopnea Index (AHI; measure of sleep apnea disease severity) [ Time Frame: 3 months and 6 months ]
    Compare the change in AHI between OMT and inactive OMT groups over the follow-up time points. Higher AHI scores indicate increase sleep apnea disease severity.


Secondary Outcome Measures :
  1. Change in Functional Outcomes of Sleep Questionnaire (FOSQ; measure of daytime functioning) [ Time Frame: 3 months and 6 months ]
    Compare the change in FOSQ between OMT and inactive OMT groups over the follow-up time points. Higher FOSQ scores indicate improved levels of daytime functioning.

  2. Change in Epworth Sleepiness Score (ESS; measure of sleepiness) [ Time Frame: 3 months and 6 months ]
    Change in ESS between OMT and inactive OMT groups over the follow-up time points. Higher ESS scores indicate higher sleepiness levels.

  3. Change in Pittsburgh Sleep Quality Index (PSQI; measure of sleep quality) [ Time Frame: 3 months and 6 months ]
    Change in PSQI between OMT and inactive OMT groups over the follow-up time points. Higher PSQI scores indicate worse sleep quality.



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Ages Eligible for Study:   18 Years to 70 Years   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  • Mild-to-moderate OSA
  • Entry criteria are as inclusive as possible and operationalized as follows: age>18 years old
  • Confirmed diagnosis of OSA
  • Having chronic symptoms per screening symptom checklist
  • Fluency in English
  • receiving medical care at VA San Diego Healthcare System

Exclusion Criteria:

  • Cognitive impairment sufficient to cause inability to complete the protocol (per medical chart review)
  • Low health literacy
  • Residence in a geographical area outside of San Diego County
  • Fatal comorbidity (life expectancy <6 months as indicated by treating physician)
  • Significant documented substance/chemical abuse

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): NCT04608552


Contacts
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Contact: Tania Zamora, MS (858) 642-3269 tania.zamora@va.gov
Contact: Carl J Stepnowsky, Jr., PhD (858) 642-1240 Carl.Stepnowsky@va.gov

Locations
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United States, California
VA San Diego Healthcare System, San Diego, CA Recruiting
San Diego, California, United States, 92161
Contact: Tania Zamora, MS    858-642-3269    tania.zamora@va.gov   
Contact: Carl J Stepnowsky, Jr., PhD    (858) 642-1240    Carl.Stepnowsky@va.gov   
Principal Investigator: Carl J Stepnowsky, Jr., PhD         
Sponsors and Collaborators
VA Office of Research and Development
Investigators
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Principal Investigator: Carl J Stepnowsky, Jr., PhD VA San Diego Healthcare System, San Diego, CA
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Responsible Party: VA Office of Research and Development
ClinicalTrials.gov Identifier: NCT04608552    
Other Study ID Numbers: D2651-R
First Posted: October 29, 2020    Key Record Dates
Last Update Posted: February 18, 2022
Last Verified: February 2022
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
Product Manufactured in and Exported from the U.S.: No
Keywords provided by VA Office of Research and Development:
Sleep Apnea
Myofunctional Therapy
Chronic Disease
Additional relevant MeSH terms:
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Apnea
Sleep Apnea Syndromes
Sleep Apnea, Obstructive
Respiration Disorders
Respiratory Tract Diseases
Signs and Symptoms, Respiratory
Sleep Disorders, Intrinsic
Dyssomnias
Sleep Wake Disorders
Nervous System Diseases