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 : October 30, 2020
|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 2022|
|Estimated Study Completion Date :||December 2022|
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 Tikkanenemail@example.com|
|Contact: Jeremy Bigalkefirstname.lastname@example.org|
|United States, Montana|
|Montana State University||Recruiting|
|Bozeman, Montana, United States, 59717|
|Contact: Anne Tikkanen 406-994-2292 email@example.com|
|Principal Investigator:||Jason Carter, PhD||Montana State University|