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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).

Must not have

History of prior neck surgery with transection of the infrahyoid strap muscles as determined by clinical history.

Timeline

Screening 3 weeks

Treatment Varies

Follow Up collected during a single operative procedure, taking about 15 minutes

Awards & highlights

No Placebo-Only Group

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.

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.

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.

Eligibility Criteria

Inclusion Criteria

You may be eligible if you check “Yes” for the criteria below

Select...

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.

Exclusion Criteria

You may be eligible for the trial if you check “No” for criteria below:

Select...

I had neck surgery that involved cutting muscles below my voice box.

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

This trial's timeline: 3 weeks for screening, Varies for treatment, and collected during a single operative procedure, taking about 15 minutes for reporting.

Treatment Details

Study Objectives

Study objectives can provide a clearer picture of what you can expect from a treatment.

Primary study objectives

Primary Objective

Secondary study objectives

Secondary Objective

Awards & Highlights

No Placebo-Only Group

All patients enrolled in this study will receive some form of active treatment.

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.

0 / 3Eligibility criteria met