Actively Recruiting
Cardiometabolic Risk Effects of Short-term Cessation of Neurostimulation Therapy
Led by Columbia University · Updated on 2025-07-10
60
Participants Needed
1
Research Sites
155 weeks
Total Duration
On this page
Sponsors
C
Columbia University
Lead Sponsor
A
American Academy of Sleep Medicine
Collaborating Sponsor
AI-Summary
What this Trial Is About
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).
CONDITIONS
Official Title
Cardiometabolic Risk Effects of Short-term Cessation of Neurostimulation Therapy
Who Can Participate
Eligibility Criteria
You may qualify if you...
- English-speaking adults 18 years or older who have had at least a 50% reduction in apnea-hypopnea index to less than 20 with hypopneas defined by 4% oxyhemoglobin desaturations after HGNS therapy
- Using HGNS therapy for at least 3 months
- Used HGNS therapy for more than 20 hours per week in the past 4 weeks
- No use of any obstructive sleep apnea therapy for at least one month before HGNS activation or a one-month untreated period of OSA after HGNS activation
You will not qualify if you...
- Chronic use of opiate medications, illicit drugs, or alcohol dependency
- Women who are pregnant or plan to become pregnant
- Shift workers, heavy machinery operators, or commercial drivers
- History of severe excessive daytime sleepiness (Epworth Sleepiness Scale score above 16) or drowsy driving incidents within the past year
- Significant cardiopulmonary disease requiring home oxygen, liver, kidney, cancer, neurodegenerative disease, or recent eating disorder within last 5 years
- Inability to provide informed consent
AI-Screening
AI-Powered Screening
Complete this quick 3-step screening to check your eligibility
Trial Site Locations
Total: 1 location
1
Columbia University Medical Center
New York, New York, United States, 10032
Actively Recruiting
Research Team
O
Otolaryngology Research Group
CONTACT
How is the study designed?
Study Type
INTERVENTIONAL
Masking
SINGLE
Allocation
RANDOMIZED
Model
CROSSOVER
Primary Purpose
TREATMENT
Number of Arms
2
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