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Behavioural Intervention
ACN Stimulation for Obstructive Sleep Apnea (ACS Trial)
N/A
Recruiting
Led By David T. Kent, MD
Research Sponsored by Vanderbilt University Medical Center
Eligibility Criteria Checklist
Specific guidelines that determine who can or cannot participate in a clinical trial Must have
Scheduled for uni- or bilateral neck dissection (BND) for cervical lymphadenectomy of level IV and other indicated procedures for management of head and neck cancer.
Adult patient (≥18 years old).
Timeline
Screening 3 weeks
Treatment Varies
Follow Up collected during a single operative procedure, taking about 15 minutes
Awards & highlights
ACS Trial Summary
This trial will examine the anatomy of the ansa cervicalis and its effect on stimulating muscles to help improve sleep apnea.
Who is the study for?
This trial is for adults over 18 who are scheduled for neck surgery due to head and neck cancer. They must be able to give consent, without pre-existing neurological conditions or language barriers that prevent understanding the research, and no history of prior neck surgery that cut the infrahyoid strap muscles.Check my eligibility
What is being tested?
The study tests nerve stimulation on a nerve called ansa cervicalis during surgery. It aims to see if stimulating this nerve can help open up the airway in patients with obstructive sleep apnea by activating certain neck muscles.See study design
What are the potential side effects?
While specific side effects aren't listed, potential risks may include discomfort at the stimulation site, infection risk from electrode placement, or unexpected changes in muscle function.
ACS Trial Eligibility Criteria
Inclusion Criteria
You may be eligible if you check “Yes” for the criteria belowSelect...
I am scheduled for surgery to remove lymph nodes in my neck due to head and neck cancer.
Select...
I am 18 years old or older.
ACS Trial Timeline
Screening ~ 3 weeks3 visits
Treatment ~ Varies
Follow Up ~ collected during a single operative procedure, taking about 15 minutes
Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~collected during a single operative procedure, taking about 15 minutes
Treatment Details
Study Objectives
Outcome measures can provide a clearer picture of what you can expect from a treatment.Primary outcome measures
Primary Objective
Secondary outcome measures
Secondary Objective
ACS Trial Design
1Treatment groups
Experimental Treatment
Group I: Surgical ProcedureExperimental Treatment1 Intervention
Consented patients who meet eligibility will have a surgical procedure for management of head and neck cancer, with dissection and exposure of the relevant anatomic structures as part of regular clinical care.
Find a Location
Who is running the clinical trial?
Vanderbilt University Medical CenterLead Sponsor
853 Previous Clinical Trials
671,018 Total Patients Enrolled
David T. Kent, MDPrincipal InvestigatorVanderbilt University Medical Center
3 Previous Clinical Trials
220 Total Patients Enrolled
Media Library
Eligibility Criteria:
This trial includes the following eligibility criteria:- I had neck surgery that involved cutting muscles below my voice box.I am scheduled for surgery to remove lymph nodes in my neck due to head and neck cancer.I am 18 years old or older.
Research Study Groups:
This trial has the following groups:- Group 1: Surgical Procedure
Awards:
This trial has 1 awards, including:- No Placebo-Only Group - All patients enrolled in this study will receive some form of active treatment.
Timeline:
This trial has the following timeline:- Screening: It may take up to 3 Weeks to process to see if you qualify in this trial.
- Treatment: The duration you will receive the treatment varies.
- Follow Ups: You may be asked to continue sharing information regarding the trial for 6 Months after you stop receiving the treatment.
Frequently Asked Questions
These questions and answers are submitted by anonymous patients, and have not been verified by our internal team.
What is the total participant count for this investigation?
"Affirmative. The trial's presence on clinicaltrials.gov confirms that it is currently recruiting individuals to participate in the study which was initially posted on February 28th 2023 and edited as recently as April 21st 2023. 50 participants are needed from a single site for this medical research endeavour."
Answered by AI
Are there any vacancies available for this experiment?
"Affirmative. Clinicaltrials.gov records confirm that this ongoing medical trial, initially posted on February 28th 2023, is actively welcoming participants. Approximately 50 patients are sought from 1 research centre."
Answered by AI
Who else is applying?
What site did they apply to?
Vanderbilt University Medical Center
What portion of applicants met pre-screening criteria?
Did not meet criteria
Why did patients apply to this trial?
I’ve used a cpap for decades. An alternative would be life changing!
PatientReceived no prior treatments
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