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| Name | Class |
|---|---|
| University of Chicago | OTHER |
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This study aims to evaluate the effect of Suvorexant on sympathetic nerve activity and baroreflex function in subject with chronic insomnia. The investigator's central hypothesis is that Suvorexant will reduce sympathetic nerve activity and improve baroreflex function when compared to placebo.
This study will utilize a randomized, double-blind, placebo-controlled experimental approach to determine the effects of 8-wk treatment with Suvorexant (Belsomra®) on sympathetic nerve activity and baroreflex function in male and female subjects with chronic insomnia. The study will utilize established techniques for assessing sleep (polysomnography), blood pressure (sphygmomanometer and beat-to-beat finger plethysmography), and peripheral sympathetic nerve activity (microneurography). The study will stratify enrollment based upon both age and sex (i.e., male vs. female) because these two covariates are known to influence sympathetic nerve activity and baroreflex function.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Drug (Suvorexant) | Experimental | 20 mg of Suvorexant daily (taken orally ~1 hour before bedtime) |
|
| Placebo | Placebo Comparator | 20 mg of Placebo daily (taken orally ~1 hour before bedtime) |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Suvorexant | Drug | Insomnia subjects will take a nightly pill of 20 mg Suvorexant for eight weeks. |
|
| Measure | Description | Time Frame |
|---|---|---|
| Sympathetic nerve activity | Direct recordings of muscle sympathetic nerve activity from the peroneal nerve using a microelectrode. | 8 weeks |
| Baroreflex sensitivity | The linear relationship between changes in beat-to-beat diastolic arterial pressure and changes in sympathetic nerve activity. | 8 weeks |
| Measure | Description | Time Frame |
|---|---|---|
| Sympathetic reactivity | The change in muscle sympathetic nerve activity during a cold pressor test. | 8 weeks |
| Home sleep quality: Wrist actigraphy | Wrist actigraphy will be used to to determine the quality of sleep, with a primary focus on sleep efficiency. |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Role | Phone | Extension | |
|---|---|---|---|---|
| Anne Tikkanen | Contact | 406-994-2292 | anne.tikkanen@montana.edu | |
| Jeremy Bigalke | Contact | 406-994-2292 | jeremy.bigalke@student.montana.edu |
| Name | Affiliation | Role |
|---|---|---|
| Jason Carter, PhD | Montana State University | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Montana State University | Recruiting | Bozeman | Montana | 59717 | United States |
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| ID | Term |
|---|---|
| D007319 | Sleep Initiation and Maintenance Disorders |
| ID | Term |
|---|---|
| D020919 | Sleep Disorders, Intrinsic |
| D020920 | Dyssomnias |
| D012893 | Sleep Wake Disorders |
| D009422 | Nervous System Diseases |
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| ID | Term |
|---|---|
| C551624 | suvorexant |
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| Placebo | Drug | Insomnia subjects will take a nightly pill of 20 mg placebo for eight weeks. |
|
| 8 weeks |
| Laboratory sleep quality: Polysomnography | Polysomnography will be used to determine the quality of sleep, with a primary focus on sleep efficiency. | 8 week |
| D001523 |
| Mental Disorders |