Effect of Orofacial Myofunctional Therapy on Unintentional Air Leak From the Oral Cavity in Patients With Obstructive Sleep Apnea Treated With Continuous Positive Upper Airway Pressure (CPAP)
Trial Snapshot
- Phase
- Not Applicable
- Status
- Terminated
- Enrollment
- 20
- Locations
- 1
- Primary Endpoint
- Effect of Orofacial Myofunctional Therapy on mouth air leak
Study Overview
Brief Summary
To verify the effect of orofacial myofunctional therapy in patients with OSA during the use of CPAP with a nasal mask, on the frequency and leak flow. In addition, the impact on mouth opening frequency, sleep quality, perception of excessive daytime sleepiness, and CPAP adherence will be evaluated.
Detailed Description
The use of continuous positive airway pressure (CPAP) with a nasal mask during sleep is the gold standard treatment for moderate to severe obstructive sleep apnea (OSA). However, low adherence to CPAP is the main limiting factor in clinical practice. Recent studies suggest that unintentional air leak through the mouth contributes significantly to poor adherence to CPAP. Orofacial myofunctional therapy (OMT) is effective for treating mild to moderate OSA and has not been tested in patients with mouth air leaks. OSA patients using nasal CPAP and mouth air leaks will be recruited and will use the standard CPAP model and nasal mask during the first and last week of the study to record adherence and home leak. Patients will be treated by performing daily (3 times a day) orofacial myofunctional exercises aimed at strengthening the muscles of the oral cavity. Exercises will be supervised weekly for 3 months. All patients will undergo at the beginning and end of treatment: polysomnography with CPAP and nasal mask, speech-language pathology assessment adequated for OSA (scores ranging from 0 to 241, with higher values indicating greater dysfunction), quality of life questionnaire, and nasosinusal symptoms (SNOT -22), sleep quality (Pittsburgh) and sleepiness (Epworth). Polysomnography will include a pneumotachograph (Hans Rudolph) in the CPAP circuit to record flow and a magnetic jaw movement sensor (Brizzy) to record the episodes of mouth opening. The mouth air leak episodes were considered when they exceeded 20% above baseline (intentional leak with the mask fitted and mouth closed at the beginning of the PSG examination with CPAP) for a minimum of 10 seconds. Leaks ending with arousal or full awakening were considered arousal or full awakening associated with mouth air leak. Mouth opening during the leak episodes was determined by the difference between the amplitude at the end of the leak and the amplitude during the leak. Our hypothesis is that the orofacial myofunctional therapy will reduce mouth leakage in OSA patients treated with CPAP and nasal mask.
Study Design
- Study Type
- Interventional
- Allocation
- Na
- Intervention Model
- Single Group
- Primary Purpose
- Treatment
- Masking
- None
Eligibility Criteria
- Ages
- 18 Years to — (Adult, Older Adult)
- Sex
- All
- Accepts Healthy Volunteers
- No
Inclusion Criteria
- •Diagnosis of OSA (AHI>15 events/h) on use of CPAP (>3 months) with suspect mouth leak as observed by the complaint of morning dry mouth and or CPAP report indicating an excessive air leak
Exclusion Criteria
- •Central Sleep Apnea, oxygen dependent, COPD.
Arms & Interventions
Orofacial exercises and oropharyngeal functions
Orofacial exercises and oropharyngeal functions.
Intervention: Orofacial exercises and oropharyngeal functions (Behavioral)
Outcomes
Primary Outcomes
Effect of Orofacial Myofunctional Therapy on mouth air leak
Time Frame: 3 months
The reduction of mouth air leak (L/min) in PSG recordings post Orofacial Myofunctional Therapy
Secondary Outcomes
- Effect of Orofacial Myofunctional Therapy on the adherence to CPAP(3 months)
- Effect of Orofacial Myofunctional Therapy on the leak in CPAP report(3 months)
- Effect of Orofacial Myofunctional Therapy on the Pittsburgh Sleep Quality Index score(3 months)
- Effect of Orofacial Myofunctional Therapy on the Epworth Sleepiness Scale score(3 months)
Investigators
Geraldo Lorenzi Filho
Principal Investigator
University of Sao Paulo General Hospital
