RECRUITING

Cardiometabolic Risk Effects of Short-term Cessation of Neurostimulation Therapy

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Conditions

Obstructive Sleep ApneaObstructive Sleep Apnea of Adulthypoglossal nerve stimulationinspire

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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

Hypoglossal nerve stimulation (HGNS) is an implantable therapy that treats obstructive sleep apnea. The study will evaluate the effect of this treatment on cardiovascular and metabolism-related measures to see if it affects patients' risk of medical problems associated with obstructive sleep apnea (OSA).

Official Title

Cardiometabolic Risk Effects of Short-term Cessation of Effective Neurostimulation Therapy in OSA

Quick Facts

Study Start:2025-01-05
Study Completion:2028-01
Study Type:Not specified
Phase:Not Applicable
Enrollment:Not specified
Status:RECRUITING

Study ID

NCT06720545

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. * English-speaking adults (18+ years) who have met surgical efficacy criteria with HGNS, as defined by at least a 50% reduction in apnea-hypopnea index (AHI) to \<20 (with hypopneas defined by 4% oxyhemoglobin desaturations)
  2. * Have been using HGNS therapy for at least 3 months and used HGNS for \>20 hours/week during the past 4 weeks
  3. * Were not using any OSA therapy for at least one month prior to HGNS activation or have had a one-month period of untreated OSA after HGNS activation
  1. * Chronic use of opiate medications, illicit drugs, or alcohol dependency
  2. * Women who are pregnant or planning to become pregnant
  3. * Shift workers, heavy machinery operators, or commercial drivers
  4. * History of severe excessive daytime sleepiness (Epworth Sleepiness Scale score \>16 at time of screening or prior to HGNS), motor vehicle accidents or near-miss incidents due to drowsy driving within the year prior to enrollment
  5. * Significant cardiopulmonary (such as home oxygen requirement), liver, renal, or oncologic disease; neurodegenerative disease; active or recent history of an eating disorder (within the last 5 years)
  6. * Inability to provide informed consent

Contacts and Locations

Study Contact

Otolaryngology Research Group
CONTACT
646-317-3252
otosleepresearch@cumc.columbia.edu

Study Locations (Sites)

Columbia University Medical Center
New York, New York, 10032
United States

Collaborators and Investigators

Sponsor: Columbia University

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 Date2025-01-05
Study Completion Date2028-01

Study Record Updates

Study Start Date2025-01-05
Study Completion Date2028-01

Terms related to this study

Keywords Provided by Researchers

  • hypoglossal nerve stimulation
  • inspire

Additional Relevant MeSH Terms

  • Obstructive Sleep Apnea
  • Obstructive Sleep Apnea of Adult