Description Module
The Description Module contains narrative descriptions of the clinical trial, including a brief summary and detailed description. These descriptions provide important information about the study's purpose, methodology, and key details in language accessible to both researchers and the general public.
Description Module path is as follows:
Study -> Protocol Section -> Description Module
Description Module
Ignite Creation Date:
2025-12-26 @ 10:56 AM
Ignite Modification Date:
2025-12-26 @ 10:56 AM
NCT ID:
NCT05432908
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:
NCT05432908
Study Brief:
Protocol Section:
NCT05432908