Columbia University Medical Center
New York, 10032, United States
Location status: Recruiting
NCT Number: NCT06720545
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).
Interested in participating?
Request Info18 year and older
All sexes
Interventional
Not applicable
New York, 10032, United States
Location status: Recruiting
Healthy volunteers accepted: No
Only the study team can determine whether someone qualifies for participation.
Inclusion criteria
Exclusion criteria
Prior to enrollment in this study, participants will have been utilizing HGNS at a therapeutic voltage setting confirmed via overnight sleep study. As part of the trial, they will undergo a study arm that involves turning off HGNS therapy (HGNS-off) for between 2-4 weeks.
Time frame: Data will be obtained in the last 2 weeks of each study phase (HGNS-on or HGNS-off)
The investigators will measure energy expenditure using the doubly labeled water (DLW) technique and actigraphy.
Time frame: Data will be obtained in the last 2 weeks of each study phase (HGNS-on or HGNS-off).
The investigators will measure hypoxic burden based on the home sleep testing obtained during the study.
Time frame: These measures will be taken at the end of each study phase (duration of 2-4 weeks)
Homeostasis Model Assessment of Insulin Resistance (HOMA-IR) will be derived from fasting glucose and insulin
Time frame: At the end of each study phase (duration of 2-4 weeks)
Serum leptin will be measured using a double-antibody radioimmunoassay (RIA).
Time frame: At the end of each study phase (duration of 2-4 weeks)
Adiponectin levels will be analyzed using RIA.
Time frame: At the end of each study phase (duration of 2-4 weeks)
Total ghrelin will be assessed using RIA.
Time frame: At the end of each study phase (duration of 2-4 weeks)
GLP-1 will be measured by RIA after plasma extraction with 95% ethanol.
Time frame: At the end of each study phase (duration of 2-4 weeks)
E-selectin will be measured as an inflammatory marker.
Time frame: At the end of each study phase (duration of 2-4 weeks)
VEGF-A will be measured as an inflammatory marker.
Time frame: These measures will be taken at the end of each study phase (duration of 2-4 weeks)
The participants will undergo home sleep testing, which will report an AHI value.
Time frame: This measure will be taken at each study visit (duration of 1-4 weeks)
Participants' height will be measured without shoes.
Time frame: This measure will be taken at every study visit (duration 1-4 weeks)
Participants' weight will be measured after a urine void
Time frame: This measure will be taken at every study visit (duration 1-4 weeks)
Participants' waist circumference will be measured
Time frame: Data will be obtained in the last 2 weeks of each study phase (HGNS-on or HGNS-off)
The investigators will measure sleep duration in minutes based on actigraphy.
Contact information is provided by the study sponsor or research team.
Columbia University
Other
Cardiometabolic Risk Effects of Short-term Cessation of Effective Neurostimulation Therapy in OSA
Acronym: CRESCENT
OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.
View the official ClinicalTrials.gov record (opens in a new tab)This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.
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