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Effects of maintaining tongue protrusion on respiration

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

Status
Active, not recruiting
Phases
Unknown
Study type
Interventional
Source
JPRN
Registry ID
JPRN-jRCTs032220040
Enrollment
26
Registered
2022-04-25
Start date
2023-06-12
Completion date
Unknown
Last updated
2026-06-29

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Upper airway obstruction Upper airway obstruction

Interventions

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

Sponsors

Masuda Rikuo
Lead Sponsor
Tsuiki Satoru
Collaborator

Eligibility

Sex/Gender
Male

Inclusion criteria

Inclusion criteria: 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

Exclusion criteria

Exclusion criteria: 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.

Design outcomes

Primary

MeasureTime frame
Abnormal Breathing Index - Apnea: ABI-A

Secondary

MeasureTime frame
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

Contacts

Public ContactAkiko Nishimura

Showa Medical University Hospital

nishim@dent.showa-u.ac.jp+81-3-3784-8575

Outcome results

None listed

Source: JPRN (via WHO ICTRP) · Data processed: Jul 3, 2026