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

JRCT ID: jRCTs032230605

Registered date:30/01/2024

Basic Information

• Recruitment status: Recruiting
• Health condition(s) or Problem(s) studied: Sleep apnea
• Date of first enrollment: 30/01/2024
• Target sample size: 30
• Study type: Interventional
• Intervention(s): Under intravenous sedation, electrical stimulation is applied to the submental using a percutaneous electrical stimulator, and changes in upper airway collapsibility are evaluated using pneumotachograph and transnasal endoscopy.

Outcome(s)

• Primary Outcome: The BiPAP pressure at which the maximum respiratory flow is 0 (Pclose), and the maximum respiratory flow at tje BiPAP pressure is 0.
• Secondary Outcome: 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.

Key inclusion & exclusion criteria

• Age minimum: >= 20age old
• Age maximum: < 65age old
• Gender: Male

Include 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

Exclude 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

Related Information

• Primary Sponsor: Kohzuka Yuuya
• Secondary Sponsor: Kawauchi Aki
• Source(s) of Monetary Support: Grants-in-Aid for Scientific Research,Research Expenses from Showa University