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| Name | Class |
|---|---|
| American Academy of Sleep Medicine | OTHER |
| Triological Society | UNKNOWN |
| American Heart Association | OTHER |
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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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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| 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. |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| 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. |
| Measure | Description | Time Frame |
|---|---|---|
| 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). |
| Measure | Description | Time Frame |
|---|---|---|
| Insulin resistance | Homeostasis Model Assessment of Insulin Resistance (HOMA-IR) will be derived from fasting glucose and insulin | These measures will be taken at the end of each study phase (duration of 2-4 weeks) |
| Measure | Description | Time Frame |
|---|---|---|
| Leptin levels | Serum leptin will be measured using a double-antibody radioimmunoassay (RIA). | At the end of each study phase (duration of 2-4 weeks) |
| Adiponectin levels | Adiponectin levels will be analyzed using RIA. |
Inclusion Criteria:
Exclusion Criteria:
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| Name | Role | Phone | Extension | |
|---|---|---|---|---|
| Otolaryngology Research Group | Contact | 646-317-3252 | otosleepresearch@cumc.columbia.edu |
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| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Columbia University Medical Center | Recruiting | New York | New York | 10032 | United States |
Participant PHI protection
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| ID | Term |
|---|---|
| D020181 | Sleep Apnea, Obstructive |
| ID | Term |
|---|---|
| D012891 | Sleep Apnea Syndromes |
| D001049 | Apnea |
| D012120 | Respiration Disorders |
| D012140 | Respiratory Tract Diseases |
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| At the end of each study phase (duration of 2-4 weeks) |
| Ghrelin levels | Total ghrelin will be assessed using RIA. | At the end of each study phase (duration of 2-4 weeks) |
| Glucagon-like peptide-1 (GLP-1) levels | GLP-1 will be measured by RIA after plasma extraction with 95% ethanol. | At the end of each study phase (duration of 2-4 weeks) |
| E-selectin levels | E-selectin will be measured as an inflammatory marker. | At the end of each study phase (duration of 2-4 weeks) |
| Vascular endothelial growth factor-A (VEGF-A) levels | VEGF-A will be measured as an inflammatory marker. | At the end of each study phase (duration of 2-4 weeks) |
| Apnea-Hypopnea Index (AHI) | The participants will undergo home sleep testing, which will report an AHI value. | These measures will be taken at the end of each study phase (duration of 2-4 weeks) |
| Height in meters | Participants' height will be measured without shoes. | This measure will be taken at each study visit (duration of 1-4 weeks) |
| Weight in kilograms | Participants' weight will be measured after a urine void | This measure will be taken at every study visit (duration 1-4 weeks) |
| Waist circumference in centimeters | Participants' waist circumference will be measured | This measure will be taken at every study visit (duration 1-4 weeks) |
| Sleep duration (minutes) | The investigators will measure sleep duration in minutes based on actigraphy. | Data will be obtained in the last 2 weeks of each study phase (HGNS-on or HGNS-off) |
| D020919 |
| Sleep Disorders, Intrinsic |
| D020920 | Dyssomnias |
| D012893 | Sleep Wake Disorders |
| D009422 | Nervous System Diseases |