A Study to Evaluate Adherence to Myofunctional Therapy Protocol

Overview

About this study

The objectives of Aim 1 of this feasibility study are to develop a digitized myofunctional therapy protocol effective for OSA treatment Aim 2, to implement an interactive treatment supported with habit formation techniques for Aim 3, and to test the adherence to the protocol while using the developed system and compare to a control group.

Participation eligibility

Participant eligibility includes age, gender, type and stage of disease, and previous treatments or health concerns. Guidelines differ from study to study, and identify who can or cannot participate. There is no guarantee that every individual who qualifies and wants to participate in a trial will be enrolled. Contact the study team to discuss study eligibility and potential participation.

Inclusion Criteria:

  • Diagnosis of obstructive sleep apnea obtained or confirmed within last 1 year with an in-lab polysomnography with Apnea Hypopnea Index ≥ 5 events/hour and < 30 events/hour.
  • Poor tolerance or willingness to accept alternatives to the currently available standard Obstructive Sleep Apnea (OSA). OSA is a chronic disease and the most common form of Sleep-Disordered Breathing. It impairs quality of OSA treatments (CPAP and/or mandibular advancement device).
  • Ownership for a smartphone capable of playing gamified Orofacial Myofunctional Therapy (OMT) protocol.
  • Ability to follow on screen instructions while using gamified OMT protocol.

Exclusion Criteria:

  • Significant co-morbid sleep disorders including excessive daytime sleepiness (Epworth sleepiness scale > 10), uncontrolled restless legs syndrome, insomnia
  • Significant medical comorbidities including severe cardiopulmonary disease, chronic rhinosinusitis, neuromuscular disorder.
  • Significant mental health comorbidities including history of uncontrolled anxiety, obsessive compulsive behavior and display of addictive behavior towards digital technology.
  • Previous upper airway surgeries significantly modifying upper airway anatomy.
  • Known congenital or acquired diseases significantly affecting upper airway anatomy.

Participating Mayo Clinic locations

Study statuses change often. Please contact the study team for the most up-to-date information regarding possible participation.

Mayo Clinic Location Status Contact

Scottsdale/Phoenix, Ariz.

Mayo Clinic principal investigator

Umesh Goswami, M.B.B.S., M.D.

Open for enrollment

Contact information:

April Howard R.N.

(480) 342-5756

Howard.April@mayo.edu

More information

Publications

Publications are currently not available