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A study on the efficacy of a non-invasive electrical stimulation device for upper airway obstruction

Can noninvasive continuous submental electrical stimulation reduce upper airway obstruction during sedation? - EMS study

Status
Active, not recruiting
Phases
Unknown
Study type
Interventional
Source
JPRN
Registry ID
JPRN-jRCTs032230605
Enrollment
30
Registered
2024-01-30
Start date
2024-01-30
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

Sleep apnea

Interventions

Under intravenous sedation, electrical stimulation is applied to the submental using a percutaneous electrical stimulator, and changes in upper airway collapsibility are evaluated using pneumotachogra

Sponsors

Masuda Rikuo
Lead Sponsor
Kawauchi Aki
Collaborator

Eligibility

Sex/Gender
Male

Inclusion criteria

Inclusion criteria: 1) Males over 20-year-old under 65-year-old 2) Participants who are healthy, or have mild systemic disease 3) Participants who agree to participate in this study 4)Control group: Participants who diagnosed with no OSA as AHI 0 - 5 times/hour 4)Severe OSA group: Participants who diagnosed with severe OSA as AHI over 30 times/hour

Exclusion criteria

Exclusion criteria: 1) Persons who have bleeding tendencies 2) Persons who have sensory impairment 3) Persons who have tonsil hypertrophy of McKenzie grade 3 or higher, or nasal congestion 4) Persons who cannot attach the electrodes due to neck disease or injury 5) Persons with medical electronic devices such as cardiac pacemakers or implantable cardioverter-defibrillators 6) Persons with diseases considered inappropriate for research participation 7) Persons who are taking drugs that are considered to affect intravenous sedation, such as sleeping pills 8) Persons who have participated in other research within 12 weeks before obtaining informed consent 9) Persons who are judged to be ineligible fot this study by the doctor

Design outcomes

Primary

MeasureTime frame
The BiPAP pressure at which the maximum respiratory flow is 0 (Pclose), and the maximum respiratory flow at tje BiPAP pressure is 0.

Secondary

MeasureTime frame
Data from pneumotachograph, BiPAP, transnasal endoscopy, type 3 portable sleep apnea monitor, medical informations, measurement record, anesthesia records, resurt of sleep study and questionnaire, resurt of EEG recording and vital signs recording, data from variousmonitors, blood test records, etc.

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