Cardiometabolic Risk Effects of Short-term Cessation of Neurostimulation Therapy

NCT06720545 | Recruiting FDA Device

• 1 other identifier: AAAU9827
• Study Type: interventional
• Target: 60
• Locations: 1 country
• Sites: 1

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).

Conditions

Obstructive Sleep Apnea; Obstructive Sleep Apnea of Adult

Keywords

hypoglossal nerve stimulation; inspire

Outcome Measures

Primary Outcomes (2)

• Free living energy expenditure

  The investigators will measure energy expenditure using the doubly labeled water (DLW) technique and actigraphy.

  Data will be obtained in the last 2 weeks of each study phase (HGNS-on or HGNS-off)

• Hypoxic burden

  The investigators will measure hypoxic burden based on the home sleep testing obtained during the study.

  Data will be obtained in the last 2 weeks of each study phase (HGNS-on or HGNS-off).

Secondary Outcomes (1)

• Insulin resistance

  These measures will be taken at the end of each study phase (duration of 2-4 weeks)

Other Outcomes (11)

• Leptin levels

  At the end of each study phase (duration of 2-4 weeks)

• Adiponectin levels

  At the end of each study phase (duration of 2-4 weeks)

• Ghrelin levels

  At the end of each study phase (duration of 2-4 weeks)

Study Arms (2)

Therapeutic HGNS (HGNS-on)

NO INTERVENTION

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.

No HGNS therapy (HGNS-off)

OTHER

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.

Device: No HGNS therapy (HGNS-off)

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.

No HGNS therapy (HGNS-off)

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

• 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

Sponsors & Collaborators

• Columbia University: lead
• American Academy of Sleep Medicine: collaborator
• Triological Society: collaborator
• American Heart Association: collaborator

Study Sites (1)

Columbia University Medical Center

New York, New York, 10032, United States

RECRUITING

MeSH Terms

Conditions

Sleep Apnea, Obstructive

Condition Hierarchy (Ancestors)

Sleep Apnea Syndromes; Apnea; Respiration Disorders; Respiratory Tract Diseases; Sleep Disorders, Intrinsic; Dyssomnias; Sleep Wake Disorders; Nervous System Diseases

Central Study Contacts

Otolaryngology Research Group

CONTACT

646-317-3252; otosleepresearch@cumc.columbia.edu

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: SINGLE
• Who Masked: OUTCOMES ASSESSOR
• Purpose: TREATMENT
• Intervention Model: CROSSOVER
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Director of Sleep Surgery

Study Record Dates

• First Submitted: October 1, 2024
• First Posted: December 6, 2024
• Study Start: January 5, 2025
• Primary Completion (Estimated): January 1, 2027
• Study Completion (Estimated): January 1, 2028
• Last Updated: July 10, 2025

Record last verified: 2025-07

Locations

US (1)