Impact of Suvorexant on Sympathetic Nerve Activity and Baroreflex Function in Chronic Insomnia
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|ClinicalTrials.gov Identifier: NCT03768713|
Recruitment Status : Recruiting
First Posted : December 7, 2018
Last Update Posted : June 11, 2019
|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|
|Actual Study Start Date :||April 18, 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.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT03768713
|Contact: Anne Tikkanen (Michigan Tech Location)||email@example.com|
|Contact: Linda Eikeland (U Chicago Location)||firstname.lastname@example.org|
|United States, Illinois|
|University of Chicago||Recruiting|
|Chicago, Illinois, United States, 60637|
|Contact: Babak Mokhlesi, MD|
|United States, Michigan|
|Michigan Technological University||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|