Recruiting

Neurostimulation

Sponsor:

Columbia University

Code:

NCT06720545

Conditions

Obstructive Sleep Apnea

Obstructive Sleep Apnea of Adult

Eligibility Criteria

Sex: All

Age: 18+

Healthy Volunteers: Not accepted

Interventions

No HGNS therapy (HGNS-off)

Study Details

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

Study ID

NCT06720545

Start date

Jan 5, 2025

Status verified date

Jul, 2025

Completion date

Jan, 2028

Anticipated

Primary completion date

Jan, 2027

Anticipated

Eligibility Criteria

Eligibility Criteria

Sex: All

Age: 18+

Healthy Volunteers: Not accepted

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

Enrollment

60 participants

Anticipated

Allocation

Randomized

Intervention Model

Crossover

Primary purpose

Treatment

Interventions and Outcome Measures

Arms

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.

Interventions

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.

Primary outcome measure

  • Free living energy expenditure [ Time Frame: Data will be obtained in the last 2 weeks of each study phase (HGNS-on or HGNS-off) ]
  • Hypoxic burden [ Time Frame: Data will be obtained in the last 2 weeks of each study phase (HGNS-on or HGNS-off). ]

Central Contacts and Locations

Central contacts

Otolaryngology Research Group

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

Locations

Columbia University Medical Center

Recruiting

New York, New York, United States, 10032

Contacts

Jesus Lopez

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

Principal Investigator:

Yi Cai, M.D.

More Information

Sponsor

Columbia University

Last update posted

Jul 10, 2025

Last verified

Jul, 2025

Keywords

  • hypoglossal nerve stimulation
  • inspire

Trial information was received from ClinicalTrials.gov and was last updated on 2026-09-06. This information was provided to ClinicalTrials.gov by Columbia University on 2025-07-10.