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NCT Number: NCT06720545

Cardiometabolic Risk Effects of Short-term Cessation of Neurostimulation Therapy

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).

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Key information

Age range

18 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Columbia University Medical Center

New York, 10032, United States

Location status: Recruiting

Location contact

Jesus Lopez

CONTACT

[email protected]

646-317-3252

Yi Cai, M.D.

PRINCIPAL_INVESTIGATOR

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

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.

Primary outcomes

  1. Free living energy expenditure

    Time frame: 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.

  2. Hypoxic burden

    Time frame: 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 outcomes

  1. Insulin resistance

    Time frame: 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

Other outcomes

  1. Leptin levels

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

    Serum leptin will be measured using a double-antibody radioimmunoassay (RIA).

  2. Adiponectin levels

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

    Adiponectin levels will be analyzed using RIA.

  3. Ghrelin levels

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

    Total ghrelin will be assessed using RIA.

  4. Glucagon-like peptide-1 (GLP-1) levels

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

    GLP-1 will be measured by RIA after plasma extraction with 95% ethanol.

  5. E-selectin levels

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

    E-selectin will be measured as an inflammatory marker.

  6. Vascular endothelial growth factor-A (VEGF-A) levels

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

    VEGF-A will be measured as an inflammatory marker.

  7. Apnea-Hypopnea Index (AHI)

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

    The participants will undergo home sleep testing, which will report an AHI value.

  8. Height in meters

    Time frame: This measure will be taken at each study visit (duration of 1-4 weeks)

    Participants' height will be measured without shoes.

  9. Weight in kilograms

    Time frame: This measure will be taken at every study visit (duration 1-4 weeks)

    Participants' weight will be measured after a urine void

  10. Waist circumference in centimeters

    Time frame: This measure will be taken at every study visit (duration 1-4 weeks)

    Participants' waist circumference will be measured

  11. Sleep duration (minutes)

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

    The investigators will measure sleep duration in minutes based on actigraphy.

Study contacts

Contact information is provided by the study sponsor or research team.

Otolaryngology Research Group

CONTACT

[email protected]

646-317-3252

Sponsors and collaborators

Lead sponsor

Columbia University

Other

Collaborators

  • American Academy of Sleep Medicine
  • American Heart Association
  • Triological Society

Registry information

Official study title

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

Acronym: CRESCENT

Important dates

Study start
2025
Primary completion
2027
Study completion
2028
First posted
Dec 6, 2024
Registry last updated
Jul 10, 2025

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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