Cardiometabolic Risk Effects of Short-term Cessation of Neurostimulation Therapy
Trial statusRecruiting
Trial phaseNot applicable
Trial typeInterventional
Biological sexAll
Age18+
SponsorColumbia University
About this trial
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).
Eligibility criteria
This trial does not accept healthy volunteersQualifiers
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
Disqualifiers
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 commercial drivers
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
Trial design
Design model
Crossover
Treatments tested in this trial
No HGNS therapy (HGNS-off)
DevicePrior 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.
Treatment groups
60 Participants
are divided into 2 treatment groupsGroup A: Therapeutic HGNS (HGNS-on)No intervention 0 interventions
Group B: No HGNS therapy (HGNS-off)Other 1 intervention
Trial outcomes
Primary outcomes
1
Free living energy expenditure
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)2
Hypoxic burden
The investigators will measure hypoxic burden based on the home sleep testing obtained during the study.
Time frame
Data will be obtained in the last 2 weeks of each study phase (HGNS-on or HGNS-off).Secondary outcomes
1
Insulin resistance
Homeostasis Model Assessment of Insulin Resistance (HOMA-IR) will be derived from fasting glucose and insulin
Time frame
These measures will be taken at the end of each study phase (duration of 2-4 weeks)Other outcomes
1
Leptin levels
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)2
Adiponectin levels
Adiponectin levels will be analyzed using RIA.
Time frame
At the end of each study phase (duration of 2-4 weeks)3
Ghrelin levels
Total ghrelin will be assessed using RIA.
Time frame
At the end of each study phase (duration of 2-4 weeks)4
Glucagon-like peptide-1 (GLP-1) levels
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)Sponsors and contacts
Click on the lead sponsor to view all of their trials.
Columbia University
Lead sponsor
American Academy of Sleep Medicine
Collaborator
Triological Society
Collaborator
American Heart Association
Collaborator
Source ClinicalTrials.gov