Effect of Myofunctional Therapy on OSA

Effect of Myofunctional Therapy on Outcomes in Mild to Moderate Sleep Apnea

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.

Study Overview

• Status: Recruiting
• Conditions: Obstructive Sleep Apnea
• Intervention / Treatment: Behavioral: OMT Exercises; Behavioral: Nasal Breathing Exercises; Other: Use of Nasal Lavage

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.

• Study Type: Interventional
• Enrollment (Estimated): 240
• Phase: Not Applicable

Contacts and Locations

• Study Contact: Name: Tania Zamora, MS; Phone Number: (858) 642-3269; Email: tania.zamora@va.gov
• Study Contact Backup: Name: Carl J Stepnowsky, Jr., PhD; Phone Number: (858) 642-1240; Email: Carl.Stepnowsky@va.gov

Study Locations

• United States
  • California
    • San Diego, California, United States, 92161-0002
      • Recruiting
      • VA San Diego Healthcare System, San Diego, CA
      • Contact: Carl J Stepnowsky, Jr., PhD; Phone Number: (858) 642-1240; Email: Carl.Stepnowsky@va.gov
      • Contact: Tania Zamora, MS; Phone Number: 858-642-3269; Email: tania.zamora@va.gov
      • Principal Investigator: Carl J Stepnowsky, Jr., PhD

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years to 70 years (Adult, Older Adult)
• Accepts Healthy Volunteers: No

Description

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
• Must be getting care the 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

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Supportive Care
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: Single

Number of Arms

2

Arms and Interventions

Participant Group / 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

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Change in Apnea Hypopnea Index (AHI; measure of sleep apnea disease severity)	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.	3 months and 6 months

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Change in Functional Outcomes of Sleep Questionnaire (FOSQ; measure of daytime functioning)	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.	3 months and 6 months
Change in Epworth Sleepiness Score (ESS; measure of sleepiness)	Change in ESS between OMT and inactive OMT groups over the follow-up time points. Higher ESS scores indicate higher sleepiness levels.	3 months and 6 months
Change in Pittsburgh Sleep Quality Index (PSQI; measure of sleep quality)	Change in PSQI between OMT and inactive OMT groups over the follow-up time points. Higher PSQI scores indicate worse sleep quality.	3 months and 6 months

Collaborators and Investigators

• Sponsor: VA Office of Research and Development
• Investigators: Principal Investigator: Carl J Stepnowsky, Jr., PhD, VA San Diego Healthcare System, San Diego, CA

Study record dates

Study Major Dates

• Study Start (Actual): August 2, 2021
• Primary Completion (Estimated): July 31, 2024
• Study Completion (Estimated): September 30, 2024

Study Registration Dates

• First Submitted: October 20, 2020
• First Submitted That Met QC Criteria: October 28, 2020
• First Posted (Actual): October 29, 2020

Study Record Updates

• Last Update Posted (Estimated): December 11, 2023
• Last Update Submitted That Met QC Criteria: December 7, 2023
• Last Verified: December 1, 2023

More Information

Terms related to this study

• Keywords: Sleep Apnea; Chronic Disease; Myofunctional Therapy
• Additional Relevant MeSH Terms: Nervous System Diseases; Respiratory Tract Diseases; Respiration Disorders; Sleep Disorders, Intrinsic; Dyssomnias; Sleep Wake Disorders; Signs and Symptoms, Respiratory; Sleep Apnea Syndromes; Sleep Apnea, Obstructive; Apnea
• Other Study ID Numbers: D2651-R

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO

Drug and device information, study documents

• 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