Actively Recruiting
Cardiometabolic Risk Effects of Short-term Cessation of Effective Neurostimulation Therapy in Obstructive Sleep Apnea
Led by Columbia University · Updated on 2025-07-10
60
Participants Needed
1
Research Sites
52 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
Researchers are evaluating the effects of stopping hypoglossal nerve stimulation (HGNS) therapy on heart and metabolism-related health in adults with obstructive sleep apnea (OSA). This implantable therapy is designed to treat OSA, and the study aims to see how temporarily turning off the therapy impacts risks for medical problems linked to OSA. The study is interventional and randomized, focusing on short-term changes when HGNS is stopped. Participants will already have an HGNS device implanted and stabilized at a therapeutic voltage confirmed by overnight sleep study. The study has two groups: one continues HGNS therapy at the therapeutic voltage representing their baseline, and the other turns off the HGNS therapy for 2 to 4 weeks to mimic untreated OSA. This crossover allows comparison of the body's response with and without active stimulation. Throughout the study, participants will be monitored for energy expenditure and hypoxic burden during the last two weeks of each phase (HGNS-on or HGNS-off). Insulin resistance will also be measured at the end of each phase. The study involves careful tracking of these health measures while participants adhere to the assigned therapy status. Total participation duration covers both phases, enabling researchers to assess the short-term cardiometabolic effects of stopping HGNS therapy.
CONDITIONS
Brief Title
Cardiometabolic Risk Effects of Short-term Cessation of Neurostimulation Therapy
Who Can Participate
Eligibility Criteria
You may qualify if you...
- English-speaking adults aged 18 years or older
- Have met surgical efficacy criteria with HGNS, showing at least a 50% reduction in apnea-hypopnea index to less than 20
- Have used HGNS therapy for at least 3 months
- Have used HGNS therapy for more than 20 hours per week during the past 4 weeks
- Were not using any OSA therapy for at least one month prior to HGNS activation or had a one-month period of untreated 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 planning to become pregnant
- Shift workers, heavy machinery operators, or commercial drivers
- History of severe excessive daytime sleepiness (Epworth Sleepiness Scale score over 16) or drowsy driving incidents within the past year
- Significant cardiopulmonary, liver, renal, oncologic, neurodegenerative disease, or recent active eating disorder
- Inability to provide informed consent
AI-Screening
AI-Powered Screening
Complete this quick 3-step screening to check your eligibility
Your Study Journey
Duration - 2 to 4 weeks
Participants are screened for eligibility to participate in the trial.
Duration - 2 to 4 weeks per phase
Participants alternate between periods of having their neurostimulation therapy turned off and periods maintaining their therapeutic neurostimulation therapy, each lasting between 2 to 4 weeks.
Visits occur at the end of each phase to assess outcomes
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
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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