Obstructive Sleep Apnea, Obstructive Sleep Apnea of Adult
Conditions
Keywords
hypoglossal nerve stimulation, inspire
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).
Interventions
DEVICENo 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.
Sponsors
American Academy of Sleep Medicine
Triological Society
American Heart Association
Columbia University
Study design
Allocation
RANDOMIZED
Intervention model
CROSSOVER
Primary purpose
TREATMENT
Masking
SINGLE (Outcomes Assessor)
Eligibility
Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
No
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
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Free living energy expenditure | 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. |
| Hypoxic burden | 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
| Measure | Time frame | Description |
|---|---|---|
| Insulin resistance | 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
| Measure | Time frame | Description |
|---|---|---|
| Glucagon-like peptide-1 (GLP-1) levels | 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. |
| E-selectin levels | At the end of each study phase (duration of 2-4 weeks) | E-selectin will be measured as an inflammatory marker. |
| Vascular endothelial growth factor-A (VEGF-A) levels | At the end of each study phase (duration of 2-4 weeks) | VEGF-A will be measured as an inflammatory marker. |
| Apnea-Hypopnea Index (AHI) | 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. |
| Leptin levels | At the end of each study phase (duration of 2-4 weeks) | Serum leptin will be measured using a double-antibody radioimmunoassay (RIA). |
| Weight in kilograms | This measure will be taken at every study visit (duration 1-4 weeks) | Participants' weight will be measured after a urine void |
| Waist circumference in centimeters | This measure will be taken at every study visit (duration 1-4 weeks) | Participants' waist circumference will be measured |
| Sleep duration (minutes) | 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. |
| Height in meters | This measure will be taken at each study visit (duration of 1-4 weeks) | Participants' height will be measured without shoes. |
| Adiponectin levels | At the end of each study phase (duration of 2-4 weeks) | Adiponectin levels will be analyzed using RIA. |
| Ghrelin levels | At the end of each study phase (duration of 2-4 weeks) | Total ghrelin will be assessed using RIA. |
Countries
United States
Contacts
Primary ContactOtolaryngology Research Group
Outcome results
None listed