Metabolic Assessments of Neurostimulation to Reduce Apnea

Description

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

Conditions

Obstructive Sleep Apnea, Obstructive Sleep Apnea of Adult

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Study Overview

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Study Details

Study overview

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

Metabolic Assessments of Hypoglossal Nerve Stimulation Therapy to Reduce Apnea

Metabolic Assessments of Neurostimulation to Reduce Apnea

Condition
Obstructive Sleep Apnea
Intervention / Treatment

-

Contacts and Locations

New York

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

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.

For general information about clinical research, read Learn About Studies.

Eligibility Criteria

  • * 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)
  • * Have been using HGNS therapy for at least 3 months and used HGNS for \>20 hours/week during the past 4 weeks
  • * 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
  • * Chronic use of opiate medications, illicit drugs, or alcohol dependency
  • * Women who are pregnant or planning to become pregnant
  • * Shift workers, heavy machinery operators, or unable to avoid driving during the HGNS withdrawal portion of the study (e.g. commercial drivers)
  • * Lack of a sleep study at their current HGNS voltage within the last three years
  • * 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
  • * 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)
  • * Inability to provide informed consent

Ages Eligible for Study

18 Years to

Sexes Eligible for Study

ALL

Accepts Healthy Volunteers

No

Collaborators and Investigators

Columbia University,

Study Record Dates

2028-01