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Effect of Myofunctional Therapy on OSA

Primary Purpose

Obstructive Sleep Apnea

Status
Recruiting
Phase
Not Applicable
Locations
United States
Study Type
Interventional
Intervention
OMT Exercises
Nasal Breathing Exercises
Use of Nasal Lavage
Sponsored by
VA Office of Research and Development
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional supportive care trial for Obstructive Sleep Apnea focused on measuring Sleep Apnea, Myofunctional Therapy, Chronic Disease

Eligibility Criteria

18 Years - 70 Years (Adult, Older Adult)All SexesDoes not accept 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
  • 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

Sites / Locations

  • VA San Diego Healthcare System, San Diego, CARecruiting

Arms of the Study

Arm 1

Arm 2

Arm Type

Active Comparator

Sham Comparator

Arm Label

Active Myofunctional Therapy

Inactive Myofunctional Therapy

Arm Description

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

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.

Outcomes

Primary Outcome Measures

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.

Secondary Outcome Measures

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.
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.
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.

Full Information

First Posted
October 20, 2020
Last Updated
January 9, 2023
Sponsor
VA Office of Research and Development
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1. Study Identification

Unique Protocol Identification Number
NCT04608552
Brief Title
Effect of Myofunctional Therapy on OSA
Official Title
Effect of Myofunctional Therapy on Outcomes in Mild to Moderate Sleep Apnea
Study Type
Interventional

2. Study Status

Record Verification Date
January 2023
Overall Recruitment Status
Recruiting
Study Start Date
August 2, 2021 (Actual)
Primary Completion Date
March 31, 2024 (Anticipated)
Study Completion Date
September 30, 2024 (Anticipated)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
VA Office of Research and Development

4. Oversight

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
Data Monitoring Committee
No

5. Study Description

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.
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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Obstructive Sleep Apnea
Keywords
Sleep Apnea, Myofunctional Therapy, Chronic Disease

7. Study Design

Primary Purpose
Supportive Care
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
Participant
Allocation
Randomized
Enrollment
240 (Anticipated)

8. Arms, Groups, and Interventions

Arm Title
Active Myofunctional Therapy
Arm Type
Active Comparator
Arm Description
Active Myofunctional Therapy is comprised of five 30-minute weekly sessions for 4 weeks.
Arm Title
Inactive Myofunctional Therapy
Arm Type
Sham Comparator
Arm 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.
Intervention Type
Behavioral
Intervention Name(s)
OMT Exercises
Intervention Description
Oral and oropharyngeal exercises
Intervention Type
Behavioral
Intervention Name(s)
Nasal Breathing Exercises
Intervention Description
Nasal breathing exercises each week
Intervention Type
Other
Intervention Name(s)
Use of Nasal Lavage
Intervention Description
Use of nasal lavage with application of 10ml of saline in each nostril two times per day
Primary Outcome Measure Information:
Title
Change in Apnea Hypopnea Index (AHI; measure of sleep apnea disease severity)
Description
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.
Time Frame
3 months and 6 months
Secondary Outcome Measure Information:
Title
Change in Functional Outcomes of Sleep Questionnaire (FOSQ; measure of daytime functioning)
Description
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.
Time Frame
3 months and 6 months
Title
Change in Epworth Sleepiness Score (ESS; measure of sleepiness)
Description
Change in ESS between OMT and inactive OMT groups over the follow-up time points. Higher ESS scores indicate higher sleepiness levels.
Time Frame
3 months and 6 months
Title
Change in Pittsburgh Sleep Quality Index (PSQI; measure of sleep quality)
Description
Change in PSQI between OMT and inactive OMT groups over the follow-up time points. Higher PSQI scores indicate worse sleep quality.
Time Frame
3 months and 6 months

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
70 Years
Accepts Healthy Volunteers
No
Eligibility 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 Must be getting care the VA San Diego Healthcare System 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
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
Tania Zamora, MS
Phone
(858) 642-3269
Email
tania.zamora@va.gov
First Name & Middle Initial & Last Name or Official Title & Degree
Carl J Stepnowsky, Jr., PhD
Phone
(858) 642-1240
Email
Carl.Stepnowsky@va.gov
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Carl J Stepnowsky, Jr., PhD
Organizational Affiliation
VA San Diego Healthcare System, San Diego, CA
Official's Role
Principal Investigator
Facility Information:
Facility Name
VA San Diego Healthcare System, San Diego, CA
City
San Diego
State/Province
California
ZIP/Postal Code
92161
Country
United States
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Tania Zamora, MS
Phone
858-642-3269
Email
tania.zamora@va.gov
First Name & Middle Initial & Last Name & Degree
Carl J Stepnowsky, Jr., PhD
Phone
(858) 642-1240
Email
Carl.Stepnowsky@va.gov
First Name & Middle Initial & Last Name & Degree
Carl J Stepnowsky, Jr., PhD

12. IPD Sharing Statement

Plan to Share IPD
No

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Effect of Myofunctional Therapy on OSA

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