Cardiometabolic Risk Effects of Short-term Cessation of Neurostimulation Therapy
For patients and families
In plain language
An automatic summary of structured registry data. It is an orientation aid, not a substitute for the official protocol or a physician assessment.
- What is being studied
- The protocol lists: No HGNS therapy (HGNS-off).
- Who it may be relevant to
- Registry conditions: Obstructive Sleep Apnea, Obstructive Sleep Apnea of Adult. Basic parameters: from 18 years · All.
- What needs checking
- Age, condition and sex are only basic indicators. Prior treatment, laboratory values and other mandatory requirements appear in the eligibility criteria below.
- Where it takes place
- United States
- Next step
- Save the trial, show it to the treating physician, and confirm current recruitment with the study center. Costs, documents and travel →
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Official title
Cardiometabolic Risk Effects of Short-term Cessation of Effective Neurostimulation Therapy in OSA
Overview
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).
Interventions
- Device No HGNS therapy (HGNS-off)
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.
Primary outcome measures
- Free living energy expenditure [Time frame: Data will be obtained in the last 2 weeks of each study phase (HGNS-on or HGNS-off)]
- Hypoxic burden [Time frame: Data will be obtained in the last 2 weeks of each study phase (HGNS-on or HGNS-off).]
Secondary outcome measures (1)
- Insulin resistance [Time frame: These measures will be taken at the end of each study phase (duration of 2-4 weeks)]
Eligibility criteria
Inclusion criteria
- 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
Exclusion criteria
- 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
- Significant cardiopulmonary (such as home oxygen requirement), liver, renal, or oncologic disease; neurodegenerative disease; active or recent history of an eating disorder (within the last 5 years)
- Inability to provide informed consent
Criteria are shown verbatim from the registry (in English). Final eligibility is always assessed by the study center.
Healthy volunteers: No
Study design
- Allocation
- Randomized
- Model
- Crossover
- Masking
- Single blind
- Primary purpose
- Treatment
Study locations
United States · 1 center
- Columbia University Medical Center — New York
Identifiers
NCT: NCT06720545 · AAAU9827