An interventional study of Hypoglossal nerve and/or Ansa Cervicalis stimulation in Sleep Apnea, Sleep Apnea, Obstructive and Sleep Disorder, sponsored by Invicta Medical Inc.. Active, not recruiting at 1 site in United Kingdom. Open to participants aged 18 Years and older. Per ClinicalTrials.gov, last updated 2024-05-16.
Sponsored by Invicta Medical Inc. · Not applicable, Interventional, and Basic science
This proof-of-concept study will evaluate the impact of surgically placing and stimulating the hypoglossal nerve and/or a second neural target Ansa Cervicalis, with a set of off-the-shelf electrode arrays.
1,422 studies on the registry are indexed under Apnea; 159 are open to participants now.
This study's enrollment of 7 is below the median of 50 across 965 interventional studies indexed under Apnea.
Browse Apnea studies →Invicta Medical Inc. is the lead sponsor of 5 studies on the registry; none are open to participants now.
Counted across the registry records on this site, refreshed daily.
Exclusion Criteria:
Device: Hypoglossal nerve and/or Ansa Cervicalis stimulation
Device stimulation of the hypoglossal nerve and/or Ansa Cervicalis
Incidence of participants with changes in cross-sectional area airway opening during target stimulation
Assessment of patients with changes in acute cross-sectional area airway opening measured in cm2 under nasoendoscopy when stimulating two neural targets (the HGN and AC). Video imaging and physician interpretation of nasoendoscopic images will be used to review outcome measures.
Time frame: Day 0
Assessment of changes in airflow outcomes
Assessment of acute changes in airflow when stimulating the HGN in combination with the AC during a flow limited event (hypopnea or apnea).
Time frame: Day 0
Number of participant adverse events observed during the study
To evaluate and report all observed participant adverse events observed during study.
Time frame: Day 30
Plan to share: No
No publications or documents are linked to this record.
This study is active, not recruiting, as verified in May 2024. You cannot join it, but the record below documents what was studied.
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Invicta Medical Inc.