Cardiometabolic Risk Effects of Short-term Cessation of Neurostimulation Therapy

Part of paid clinical trials in New York, New York.

Sponsor
Columbia University
Study ID
NCT06720545
Status
Recruiting
Apply to this trial

Conditions

  • Obstructive Sleep Apnea
  • Obstructive Sleep Apnea of Adult

Eligibility Criteria

Sex
ALL
Age
18 Years - N/A
Healthy Volunteers
Not accepted

Interventions

  • No HGNS therapy (HGNS-off) — DEVICE
    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.

Study Details

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).

Key Dates

Start date
Jan 5, 2025
Status verified
Jul 2025
Primary completion
Jan 31, 2027
Completion
Jan 31, 2028

Study Design

Enrollment
60 participants (estimated)
Allocation
RANDOMIZED
Intervention model
CROSSOVER
Primary purpose
TREATMENT

Arms

  • No Intervention: 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.
  • Other: 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.

Primary Outcome Measure

Free living energy expenditure [ Time Frame: Data will be obtained in the last 2 weeks of each study phase (HGNS-on or HGNS-off) ]

Central Contacts

Locations (1)

FacilityCityStateZIPSite coordinators
Columbia University Medical CenterNew YorkNew York10032
Jesus Lopez
[email protected]
646-317-3252
Yi Cai, M.D. (PRINCIPAL_INVESTIGATOR)

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By research site
Columbia University Medical Center· New York, NY

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