Ignite Creation Date:
2024-05-06 @ 3:22 PM
Last Modification Date:
2024-10-26 @ 1:48 PM
Study NCT ID:
NCT04608552
Status:
RECRUITING
Last Update Posted:
2023-12-11
First Post:
2020-10-20
Brief Title:
Effect of Myofunctional Therapy on OSA
Sponsor:
VA Office of Research and Development
Organization:
VA Office of Research and Development
Study Overview
Official Title:
Effect of Myofunctional Therapy on Outcomes in Mild to Moderate Sleep Apnea
Status:
RECRUITING
Status Verified Date:
2024-09
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
Not Stopped
Has Expanded Access:
False
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
None
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 eg tongue and oropharyngeal eg 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
Study Oversight
Has Oversight DMC:
None
Is a FDA Regulated Drug?:
False
Is a FDA Regulated Device?:
False
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
False
Is an FDA AA801 Violation?:
None