Clinical trial NCT06720545: Metabolic Assessments of Neurostimulation to Reduce Apnea
Official title: Metabolic Assessments of Hypoglossal Nerve Stimulation Therapy to Reduce Apnea
Study type: INTERVENTIONAL
Overall status: RECRUITING
Phase: NA
Conditions: Obstructive Sleep Apnea
Obstructive Sleep Apnea of Adult
Keywords: hypoglossal nerve stimulation
inspire
Lead sponsor: Columbia University
Sponsor class: OTHER
Collaborators: name: American Academy of Sleep Medicine
name: Triological Society
First posted: 2024-12-06
Enrollment: 60
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: CROSSOVER
Primary purpose: TREATMENT

Brief summary: 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).


Eligibility criteria: Inclusion 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

Exclusion Criteria:

* 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

Primary outcomes:
measure: Free living energy expenditure
timeFrame: Data will be obtained in the last 2 weeks of each study phase (HGNS-on or HGNS-off)
measure: Energy intake
timeFrame: Data will be obtained in the last 2 weeks of each study phase (HGNS-on or HGNS-off).
Secondary outcomes:
measure: Insulin resistance
timeFrame: These measures will be taken at the end of each study phase (duration of 2-4 weeks)
Other outcomes:
measure: Leptin levels
timeFrame: At the end of each study phase (duration of 2-4 weeks)
measure: Adiponectin levels
timeFrame: At the end of each study phase (duration of 2-4 weeks)
measure: Ghrelin levels
timeFrame: At the end of each study phase (duration of 2-4 weeks)
measure: Glucagon-like peptide-1 (GLP-1) levels
timeFrame: At the end of each study phase (duration of 2-4 weeks)
measure: E-selectin levels
timeFrame: At the end of each study phase (duration of 2-4 weeks)
measure: Vascular endothelial growth factor-A (VEGF-A) levels
timeFrame: At the end of each study phase (duration of 2-4 weeks)
measure: Apnea-Hypopnea Index (AHI)
timeFrame: These measures will be taken at the end of each study phase (duration of 2-4 weeks)
measure: Height in meters
timeFrame: This measure will be taken at each study visit (duration of 1-4 weeks)
measure: Weight in kilograms
timeFrame: This measure will be taken at every study visit (duration 1-4 weeks)
measure: Waist circumference in centimeters
timeFrame: This measure will be taken at every study visit (duration 1-4 weeks)
measure: Sleep duration (minutes)
timeFrame: Data will be obtained in the last 2 weeks of each study phase (HGNS-on or HGNS-off)
Locations:
city: New York
country: United States
facility: Columbia University Medical Center
state: New York
Study officials:
References: