Cardiometabolic Risk Effects of Short-term Cessation of Neurostimulation Therapy (CRESCENT)

Columbia University

Status: Enrolling

Conditions: Obstructive Sleep Apnea of Adult; Obstructive Sleep Apnea

Treatments: Device: No HGNS therapy (HGNS-off)

Study type: Interventional

Funder types: Other

Identifiers

NCT06720545

AAAU9827

Details and patient eligibility

About

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).

Enrollment: 60 estimated patients

Sex: All

Ages: 18+ years old

Volunteers: No Healthy Volunteers

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

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Crossover Assignment

Masking: Single Blind

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60 participants in 2 patient groups

Therapeutic HGNS (HGNS-on)

No Intervention group

Description:

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 group

Description:

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.

Treatment:

Device: No HGNS therapy (HGNS-off)