Cardiometabolic Risk Effects of Short-term Cessation of Effective Neurostimulation Therapy in OSA

Status: Recruiting
Location: See location...
Intervention Type: Device
Study Type: Interventional
Study Phase: Not Applicable
SUMMARY

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).

Eligibility
Participation Requirements
Sex: All
Minimum Age: 18
Healthy Volunteers: f
View:

• 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

Locations
United States
New York
Columbia University Medical Center
RECRUITING
New York
Contact Information
Primary
Otolaryngology Research Group
otosleepresearch@cumc.columbia.edu
646-317-3252
Time Frame
Start Date: 2025-01-05
Estimated Completion Date: 2028-01
Participants
Target number of participants: 60
Treatments
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.
Related Therapeutic Areas
Sponsors
Leads: Columbia University
Collaborators: Triological Society, American Heart Association, American Academy of Sleep Medicine

This content was sourced from clinicaltrials.gov