Cardiometabolic Risk Effects of Short-term Cessation of Neurostimulation Therapy
NCT ID: NCT06720545
Last Updated: 2025-07-10
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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RECRUITING
NA
60 participants
INTERVENTIONAL
2025-01-05
2028-01-31
Brief Summary
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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).
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Detailed Description
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Conditions
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Study Design
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RANDOMIZED
CROSSOVER
TREATMENT
SINGLE
Study Groups
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Therapeutic HGNS (HGNS-on)
Prior to enrollment in this study, participants will have been implanted with and stabilized on HGNS therapy. As part of clinical care, a therapeutic voltage setting will have been confirmed via overnight sleep study. This arm of the study maintains the participants on the HGNS therapy at the therapeutic voltage they have been using. This is a representation of the patient's baseline status.
No interventions assigned to this group
No HGNS therapy (HGNS-off)
HGNS therapy will be turned off by the participant for this arm of the study. This arm will mimic the participant's untreated OSA statement before they had HGNS therapy activated.
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.
Interventions
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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.
Eligibility Criteria
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Inclusion Criteria
* 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
* 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
18 Years
ALL
No
Sponsors
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American Academy of Sleep Medicine
OTHER
Triological Society
UNKNOWN
American Heart Association
OTHER
Columbia University
OTHER
Responsible Party
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Yi Cai
Director of Sleep Surgery
Locations
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Columbia University Medical Center
New York, New York, United States
Countries
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Central Contacts
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Facility Contacts
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Other Identifiers
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AAAU9827
Identifier Type: -
Identifier Source: org_study_id
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