Metabolic Assessments of Neurostimulation to Reduce Apnea

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 metabolism-related outcomes and measures of inflammation to see if it lowers 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
• Status Verified: 2025-01
• Study Start: 2025-01-05
• Last Update Submitted: 2025-01-05
• Last Update Posted: 2025-01-07
• Primary Completion: 2027-01
• Study Completion: 2028-01

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 unable to avoid driving during the HGNS withdrawal portion of the study (e.g. commercial drivers)
• Lack of a sleep study at their current HGNS voltage within the last three years
• 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
• 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.
Energy intake	Data will be obtained in the last 2 weeks of each study phase (HGNS-on or HGNS-off).	The investigators will measure energy intake via 3-day food records with the Automated Self-Administered Dietary Assessment Tool (ASA24).

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