RECRUITING

Ansa Cervicalis and Hypoglossal Nerve Stimulation in OSA

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Conditions

Obstructive Sleep Apnea

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Study Overview

This clinical trial focuses on testing the efficacy of different digital interventions to promote re-engagement in cancer-related long-term follow-up care for adolescent and young adult (AYA) survivors of childhood cancer.

Description

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.

Official Title

Ansa Cervicalis and Hypoglossal Nerve Stimulation in Obstructive Sleep Apnea

Quick Facts

Study Start:2022-11-03
Study Completion:2026-11-30
Study Type:Not specified
Phase:Not Applicable
Enrollment:Not specified
Status:RECRUITING

Study ID

NCT05501236

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Ages Eligible for Study:18 Years
Sexes Eligible for Study:ALL
Accepts Healthy Volunteers:No
Standard Ages:ADULT, OLDER_ADULT
Inclusion CriteriaExclusion Criteria
  1. 1. Consenting adults with BMI≥ 25 and ≤ 40 kg/m2
  2. 2. Obstructive sleep apnea with an AHI between 20 and 80 events/hr (with hypopneas defined by 4% oxyhemoglobin desaturations); ≥80% obstructive events.
  1. 1. Chronic use of opiate medications, illicit drug use, or alcohol dependency
  2. 2. Other known concomitant sleep disorder (e.g., central sleep apnea, periodic limb movements, narcolepsy)
  3. 3. Clinical history or evidence of cardiopulmonary disease (or oxygen use), liver, renal, immunodeficiency, neurodegenerative diseases, or previous adverse reactions to anesthesia.
  4. 4. Prior upper airway reconstructive surgery excluding tonsillectomy (e.g., cleft palate repair, uvulopalatopharyngoplasty)
  5. 5. Indwelling neurostimulation device (e.g. cardiac pacemaker, spinal, vagal, or hypoglossal nerve stimulator)

Contacts and Locations

Study Contact

Katie Hartley-Estes, RPSGT
CONTACT
615-875-9214
katherine.e.hartley@vumc.org
Kate Von Wahlde, MJ, CCRP
CONTACT
615-322-0333
kate.vonwahlde@vumc.org

Principal Investigator

David T. Kent, MD
PRINCIPAL_INVESTIGATOR
Vanderbilt University Medical Center

Study Locations (Sites)

Vanderbilt University Medical Center
Nashville, Tennessee, 37232
United States

Collaborators and Investigators

Sponsor: Vanderbilt University Medical Center

  • David T. Kent, MD, PRINCIPAL_INVESTIGATOR, Vanderbilt University Medical Center

Study Record Dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Registration Dates

Study Start Date2022-11-03
Study Completion Date2026-11-30

Study Record Updates

Study Start Date2022-11-03
Study Completion Date2026-11-30

Terms related to this study

Additional Relevant MeSH Terms

  • Obstructive Sleep Apnea