Effect of Myofunctional Therapy on OSA

VA Office of Research and Development

Status: Enrolling

Conditions: Obstructive Sleep Apnea

Treatments: Behavioral: OMT Exercises; Behavioral: Nasal Breathing Exercises; Other: Use of Nasal Lavage

Study type: Interventional

Funder types: Other U.S. Federal agency

Identifiers

NCT04608552

D2651-R

Details and patient eligibility

About

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.

Full 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.

Enrollment: 240 estimated patients

Sex: All

Ages: 18 to 70 years old

Volunteers: No Healthy Volunteers

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

Trial design

Primary purpose: Supportive Care

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Single Blind

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240 participants in 2 patient groups

Active Myofunctional Therapy

Active Comparator group

Description:

Active Myofunctional Therapy is comprised of five 30-minute weekly sessions for 4 weeks.

Treatment:

Behavioral: OMT Exercises

Inactive Myofunctional Therapy

Sham Comparator group

Description:

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.

Treatment:

Other: Use of Nasal Lavage

Behavioral: Nasal Breathing Exercises