NCT06720545

Cardiometabolic Risk Effects of Short-term Cessation of Neurostimulation Therapy

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

• Status: Recruiting
• Phase: N/A
• Study type: Interventional
• Enrollment: 60 (estimated)
• Sponsor: Columbia University · Academic / Other
• Sex: All
• Age: 18 Years
• Healthy volunteers: Not accepted

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).

Conditions

• Obstructive Sleep Apnea
• Obstructive Sleep Apnea of Adult

Interventions

Type	Name	Description
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.

Timeline

• Start date: 2025-01-05
• Primary completion: 2027-01-01
• Completion: 2028-01-01
• First posted: 2024-12-06
• Last updated: 2025-07-10

Locations

1 site across 1 country: United States

Regulatory

• FDA-regulated device study