Skip to main page content
U.S. flag

An official website of the United States government

Dot gov

The .gov means it’s official.
Federal government websites often end in .gov or .mil. Before sharing sensitive information, make sure you’re on a federal government site.

Https

The site is secure.
The https:// ensures that you are connecting to the official website and that any information you provide is encrypted and transmitted securely.

Access keys NCBI Homepage MyNCBI Homepage Main Content Main Navigation
. 2022 Aug 1;18(8):2081-2083.
doi: 10.5664/jcsm.10088.

Recruiting "clean" chronic insomnia participants: the unicorn of sleep research

Lisa Medalie  1 , Jeremy A Bigalke  2   3 , Anne L Tikkanen  2 , Babak Mokhlesi  4 , Jason R Carter  2
Affiliations

Recruiting "clean" chronic insomnia participants: the unicorn of sleep research

Lisa Medalie et al. J Clin Sleep Med. .
No abstract available

PubMed Disclaimer

Conflict of interest statement

All authors have seen and approved this manuscript. Work for this study was performed at Montana State University. This study was funded by the Merck Investigators Studies Program (MISP) (J.R.C). Additionally, the main study sponsor (Merck) has an FDA-approved drug for insomnia (Suvorexant) on the market in the USA and elsewhere. Clinical Trial Information: Information presented in the manuscript is part of an ongoing clinical trial. Title: Impact of Suvorexant on Sympathetic Nerve Activity and Baroreflex Function in Chronic Insomnia, URL: https://clinicaltrials.gov/ct2/show/NCT03768713, ClinicalTrials.gov Identifier: NCT03768713.

Figures

Figure 1
Figure 1. Flow chart of recruitment.
A representative recruitment flow diagram indicating the rate of participant dropout at various stages of the protocol. *The criteria for an actigraphy defined total sleep time < 6.5 hours/night was an initial inclusion criterion but was subsequently removed due to recruiting difficulty. MINI-7 = Mini International Neuropsychiatric Interview 7.0.2, MSNA = muscle sympathetic nerve activity, PSG = polysomnography, TST = total sleep time.
See this image and copyright information in PMC

Comment in

References

    1. Carter JR, Grimaldi D, Fonkoue IT, Medalie L, Mokhlesi B, Cauter EV . Assessment of sympathetic neural activity in chronic insomnia: evidence for elevated cardiovascular risk . Sleep. 2018. ; 41 ( 6 ): zsy048 . - PMC - PubMed
    1. Huls H, Abdulahad S, Mackus M, et al. . Inclusion and exclusion criteria of clinical trials for insomnia . J Clin Med. 2018. ; 7 ( 8 ): E206 . - PMC - PubMed
    1. Vgontzas AN, Fernandez-Mendoza J, Liao D, Bixler EO . Insomnia with objective short sleep duration: The most biologically severe phenotype of the disorder . Sleep Med Rev. 2013. ; 17 ( 4 ): 241 – 254 . - PMC - PubMed
    1. Bigalke JA, Carter JR . Sympathetic neural control in humans with anxiety-related disorders . Compr Physiol. 2021. ; 12 ( 1 ): 3085 – 3117 . - PubMed
    1. American Academy of Sleep Medicine . International Classification of Sleep Disorders: Diagnostic and Coding Manual. 2nd ed . Westchester, IL: : American Academy of Sleep Medicine; ; 2005. .