Cardiometabolic Risk Effects of Short-term Cessation of Neurostimulation Therapy

Not Applicable

Recruiting

• Conditions: Obstructive Sleep Apnea; Obstructive Sleep Apnea of Adult

• Registration Number: NCT06720545
• Lead Sponsor: Columbia University

Brief 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).

Detailed Description

Not available

Study Timeline

• Study First Submitted: 2024-10-01
• Study First Submitted QC: 2024-12-02
• Study First Posted: 2024-12-06
• Study Start: 2025-01-05
• Status Verified: 2025-07
• Last Update Submitted: 2025-07-05
• Last Update Posted: 2025-07-10
• Primary Completion: 2027-01
• Study Completion: 2028-01-01

Recruitment & Eligibility

• Status: RECRUITING
• Sex: All
• Target Recruitment: 60

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

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: CROSSOVER

Primary Outcome Measures

Name	Time	Method
Free living energy expenditure	Data will be obtained in the last 2 weeks of each study phase (HGNS-on or HGNS-off)	The investigators will measure energy expenditure using the doubly labeled water (DLW) technique and actigraphy.
Hypoxic burden	Data will be obtained in the last 2 weeks of each study phase (HGNS-on or HGNS-off).	The investigators will measure hypoxic burden based on the home sleep testing obtained during the study.

Secondary Outcome Measures

Name	Time	Method
Insulin resistance	These measures will be taken at the end of each study phase (duration of 2-4 weeks)	Homeostasis Model Assessment of Insulin Resistance (HOMA-IR) will be derived from fasting glucose and insulin

Trial Locations

Locations (1)

Columbia University Medical Center; 🇺🇸 New York, New York, United States