RecruitingNot Applicable

Ansa Cervicalis and Hypoglossal Nerve Stimulation in OSA

United States100 participantsStarted 2022-11-03

Plain-language summary

Polysomnography (PSG) and drug-induced sleep endoscopy (DISE) are widely used diagnostic studies for assessing obstructive sleep apnea (OSA) severity and collapse patterns of the upper airway anatomy during sleep. Hypoglossal nerve stimulation (HNS) therapy for obstructive sleep apnea suffers from variable response at the level of the soft palate. The Investigators propose a study examining the physiologic effect of ansa cervicalis stimulation (ACS) alone and in combination with HNS during PSG and DISE.

Who can participate

Age range

18 Years

Sex

ALL

See this in plain English?

AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.

Inclusion criteria

. Consenting adults with BMI≥ 25 and ≤ 40 kg/m2
. Obstructive sleep apnea with an AHI between 20 and 80 events/hr (with hypopneas defined by 4% oxyhemoglobin desaturations); ≥80% obstructive events.

Exclusion criteria

. Chronic use of opiate medications, illicit drug use, or alcohol dependency
. Other known concomitant sleep disorder (e.g., central sleep apnea, periodic limb movements, narcolepsy)
. Clinical history or evidence of cardiopulmonary disease (or oxygen use), liver, renal, immunodeficiency, neurodegenerative diseases, or previous adverse reactions to anesthesia.

Questions worth asking your doctor

Bring these to your next appointment. They're a starting point for a shared conversation — not a sign you qualify or a recommendation to enrol.

1Based on my diagnosis and history, is this trial worth exploring for me — or is there a standard treatment we should try first?
2What does this trial's phase tell us about how much is already known about its safety and benefit?
3What would taking part actually involve for me — visits, tests, time, and travel?
4What are the known and possible risks or side effects I should weigh, and how would they be monitored?
5If this trial isn't the right fit, what other options or trials would you suggest I look into?

Generated to help you prepare — always confirm anything about your own eligibility and care with the study team and your doctor.

Questions for the trial coordinator

The trial coordinator is the person who runs the study day to day. These cover the practical side — logistics, costs, and what taking part would actually mean for your life. The study team confirms whether you meet the criteria; these are questions to ask, not a sign you qualify.

1What does taking part actually involve week to week — how many visits, where, and how long does each one take?
2What costs are covered by the study, and what might I have to pay for myself, including travel, parking, or time off work?
3What happens during screening, and what happens if the study team confirms I don't meet the criteria after those tests?
4Who pays for the scans, blood work, and other tests the trial requires — the study, my insurance, or me?
5How will being in the trial affect my regular care, and will my own doctor stay informed and involved?
6Can I leave the trial at any point if I change my mind, and what would happen to my care if I do?

A starting point for the conversation — always confirm anything about your own eligibility, costs, and care with the study team and your doctor.

What they're measuring

Basic physiologic measurements during Drug Induced Sleep Endoscopy (DISE) - Airway cross sectional diameter

Timeframe: During DISE, approximately 15 minutes

Basic physiologic measurements during Drug Induced Sleep Endoscopy (DISE) - Airflow data

Timeframe: During DISE, approximately 15 minutes

Basic physiologic measurements during Drug Induced Sleep Endoscopy (DISE) - Upper airway pressure changes

Timeframe: During DISE, approximately 15 minutes

Basic physiologic measurements during Drug Induced Sleep Endoscopy (DISE) - Respiratory effort data

Timeframe: During DISE, approximately 15 minutes

Basic physiologic measurements during Polysomnography (PSG) - Airflow data

Timeframe: During sleep study exam (PSG), approximately 8 hours

Basic physiologic measurements during Polysomnography (PSG) - Electroencephalogram (EEG)

Timeframe: During sleep study exam (PSG), approximately 8 hours

Trial details

NCT IDNCT05501236

SponsorVanderbilt University Medical Center

Sponsor typeOTHER

Study typeINTERVENTIONAL

Primary completion2027-05-30

Contact for this trial

Katie Hartley-Estes, RPSGT

615-875-9214 katherine.e.hartley@vumc.org

View on ClinicalTrials.gov More Obstructive Sleep Apnea trials

Plain-language summary

Who can participate

Age range

18 Years

Sex

ALL

See this in plain English?

AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.

Inclusion criteria

. Consenting adults with BMI≥ 25 and ≤ 40 kg/m2
. Obstructive sleep apnea with an AHI between 20 and 80 events/hr (with hypopneas defined by 4% oxyhemoglobin desaturations); ≥80% obstructive events.

Exclusion criteria

. Chronic use of opiate medications, illicit drug use, or alcohol dependency
. Other known concomitant sleep disorder (e.g., central sleep apnea, periodic limb movements, narcolepsy)
. Clinical history or evidence of cardiopulmonary disease (or oxygen use), liver, renal, immunodeficiency, neurodegenerative diseases, or previous adverse reactions to anesthesia.

What they're measuring

Basic physiologic measurements during Drug Induced Sleep Endoscopy (DISE) - Airway cross sectional diameter

Timeframe: During DISE, approximately 15 minutes

Basic physiologic measurements during Drug Induced Sleep Endoscopy (DISE) - Airflow data

Timeframe: During DISE, approximately 15 minutes

Basic physiologic measurements during Drug Induced Sleep Endoscopy (DISE) - Upper airway pressure changes

Timeframe: During DISE, approximately 15 minutes

Basic physiologic measurements during Drug Induced Sleep Endoscopy (DISE) - Respiratory effort data

Timeframe: During DISE, approximately 15 minutes

Basic physiologic measurements during Polysomnography (PSG) - Airflow data

Timeframe: During sleep study exam (PSG), approximately 8 hours

Basic physiologic measurements during Polysomnography (PSG) - Electroencephalogram (EEG)

Timeframe: During sleep study exam (PSG), approximately 8 hours