臨床研究等提出・公開システム

Effects of tongue protrusion using tongue position retainer on upper airway occlusion: a randomized controlled study (TPR study)

Effects of maintaining tongue protrusion on respiration

Kohzuka Yuuya

Showa University Dental Hospital

2-1-1, Kitasenzoku, Ota-ku, Tokyo, Japan

kohyu@dent.showa-u.ac.jp

Kohzuka Yuuya

Showa University Hospital

1-5-8, Hatanodai, Shinagawa-ku, Tokyo, Japan

+81-3-3784-8575

kohyu@dent.showa-u.ac.jp

Recruiting

April. 25, 2022

Interventional

randomized controlled trial

open(masking not used)

no treatment control/standard of care control

crossover assignment

treatment purpose

1) Patients undergoing dental treatment under intravenous sedation.
2) Males over 20-year-old
3) Patients whose AHI is more than or equal to 10.0 events/hr and less than 30.0 events/hr based on preliminary sleep testing.
5) Patients who are healthy, or have mild systemic disease
6) Patients who agree to participate in this study

1) Patients who have congnitive and sensor impair ment
2) Patients who are judged to be ineligible fot this study by the doctor
3) Patients who don't agree to participate in this study
4) Patients whose tongue is not maintained in position by the tongue capsule of TPR prior to the study.

Male

Upper airway obstruction

Intervention group A: Maintaining the tongue in a protruded position by wearing the TPR under sedation
Intervention group B: Maintaining the tongue in position by wearing the TPR under sedation

Upper airway obstruction

Abnormal Breathing Index - Apnea: ABI-A

Data from type 3 portable sleep apnea monitor, result of sleep study and questionnaire, medical informations, result of EEG recording and vital signs recording, anesthesia records, data from various monitors

+81-3-3784-8129

April. 11, 2022

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