Impact of Suvorexant on Sympathetic Nerve Activity and Baroreflex Function in Chronic Insomnia
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|ClinicalTrials.gov Identifier: NCT03768713|
Recruitment Status : Not yet recruiting
First Posted : December 7, 2018
Last Update Posted : December 7, 2018
|Condition or disease||Intervention/treatment||Phase|
|Chronic Insomnia||Drug: Suvorexant Drug: Placebo||Phase 4|
|Study Type :||Interventional (Clinical Trial)|
|Estimated Enrollment :||34 participants|
|Intervention Model:||Parallel Assignment|
|Masking:||Double (Participant, Investigator)|
|Primary Purpose:||Basic Science|
|Official Title:||A Randomized, Double-Blind, Placebo-Controlled Study to Determine the Effect of Suvorexant (Belsomra®) on Sympathetic Neural Activity and Baroreflex Function in Patients With Chronic Insomnia|
|Estimated Study Start Date :||January 2019|
|Estimated Primary Completion Date :||August 2020|
|Estimated Study Completion Date :||December 2020|
Experimental: Drug (Suvorexant)
20 mg of Suvorexant daily (taken orally ~1 hour before bedtime)
Insomnia subjects will take a nightly pill of 20 mg Suvorexant for eight weeks.
Placebo Comparator: Placebo
20 mg of Placebo daily (taken orally ~1 hour before bedtime)
Insomnia subjects will take a nightly pill of 20 mg placebo for eight weeks.
- Sympathetic nerve activity [ Time Frame: 8 weeks ]Direct recordings of muscle sympathetic nerve activity from the peroneal nerve using a microelectrode.
- Baroreflex sensitivity [ Time Frame: 8 weeks ]The linear relationship between changes in beat-to-beat diastolic arterial pressure and changes in sympathetic nerve activity.
- Sympathetic reactivity [ Time Frame: 8 weeks ]The change in muscle sympathetic nerve activity during a cold pressor test.
- Home sleep quality: Wrist actigraphy [ Time Frame: 8 weeks ]Wrist actigraphy will be used to to determine the quality of sleep, with a primary focus on sleep efficiency.
- Laboratory sleep quality: Polysomnography [ Time Frame: 8 week ]Polysomnography will be used to determine the quality of sleep, with a primary focus on sleep efficiency.
To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT03768713
|Contact: Anne Tikkanen (Michigan Tech Location)||firstname.lastname@example.org|
|Contact: Soumia Msallek (U Chicago Location)||email@example.com|
|United States, Illinois|
|University of Chicago||Not yet recruiting|
|Chicago, Illinois, United States, 60637|
|Contact: Babak Mokhlesi, MD|
|United States, Michigan|
|Michigan Technological University||Not yet recruiting|
|Houghton, Michigan, United States, 49931|
|Contact: Jason R Carter, PhD|
|Principal Investigator:||Jason Carter, PhD||Michigan Technological University|
|Principal Investigator:||Babak Mokhlesi, MD||University of Chicago|