Effect of Myofunctional Therapy on OSA

Obstructive Sleep Apnea Clinical Trial

Official title:

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

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT04608552
• Other study ID #: D2651-R
• Status: Recruiting
• Phase: N/A
• Start date: August 2, 2021
• Est. completion date: September 30, 2024

Study information

• Verified date: December 2023
• Source: VA Office of Research and Development
• Contact: Tania Zamora, MS
• Phone: (858) 642-3269
• Email: tania.zamora[@]va.gov
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 240
• Est. completion date: September 30, 2024
• Est. primary completion date: July 31, 2024
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years to 70 Years

Eligibility

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

Related Conditions & MeSH terms

• Apnea
• Obstructive Sleep Apnea
• Sleep Apnea Syndromes
• Sleep Apnea, Obstructive

Intervention

Behavioral:
• OMT Exercises
Oral and oropharyngeal exercises
• 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

Locations

Country	Name	City	State
United States	VA San Diego Healthcare System, San Diego, CA	San Diego	California

Sponsors (1)

Lead Sponsor	Collaborator
VA Office of Research and Development

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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	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
Secondary	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
Secondary	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