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
Qualifiers
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
Treatments tested in this trial
- No HGNS therapy (HGNS-off)
Treatment groups
60 Participants
are divided into 2 treatment groupsSponsors and collaborators
Columbia University
Lead sponsor
American Academy of Sleep Medicine
Collaborator
Triological Society
Collaborator
American Heart Association
Collaborator
Source ClinicalTrials.gov