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Impact of transdermal trigeminal electrical neuromodulation on subjective and objective sleep parameters in patients with insomnia: a pilot study

  • Psychiatrics • Original Article
  • Published:
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Abstract

Purpose

Transcutaneous trigeminal electrical neuromodulation (TTEN) is a new treatment modality that has a potential to improve sleep through the suppression of noradrenergic activity. This study aimed to explore the changes of subjective and objective sleep parameters after 4-weeks of daily session of transcutaneous trigeminal electrical neuromodulation in a group of patients with insomnia.

Methods

In a group of patients with insomnia, TTEN targeting the ophthalmic division of the trigeminal nerve was utilized to test the effects of transcutaneous trigeminal electrical neuromodulation. Patients went through daily 20-min sessions of TTEN for 4 weeks. Polysomnography parameters, Pittsburgh sleep quality index, insomnia severity index, and Epworth sleepiness scale were obtained pre- and post-intervention. Changes in these parameters were compared and analyzed.

Results

Among 13 patients with insomnia there was a statistically significant reduction in Pittsburgh sleep quality index, insomnia severity index, and Epworth sleepiness scale scores after 4-week daily sessions of TTEN. There were no differences in polysomnography parameters pre- and post-intervention.

Conclusion

This is the first study to demonstrate the effects of TTEN in a group of insomnia patients. TTEN may improve subjective parameters in patients with insomnia. Further replication studies are needed to support this finding.

Trial registration

The data presented in the study are from a study exploring the effect of TTEN on insomnia (www.clinicaltrials.gov, registration number: NCT04838067, date of registration: April 8, 2021, “retrospectively registered”)

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Data availability

Data can be opened publicly when requested.

Code availability

Not applicable.

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Funding

This work was supported by the National Research Foundation of Korea (NRF) grant funded by the Korea government (MSIT) (No. 2018R1D1A1A02049615).

Author information

Authors and Affiliations

  1. Department of Psychiatry, St.Vincent’s Hospital, College of Medicine, The Catholic University of Korea, Seoul, Republic of Korea

    Yoo Hyun Um

  2. Department of Psychiatry, Yeouido St. Mary’s Hospital, College of Medicine, The Catholic University of Korea, Seoul, Republic of Korea

    Sheng-Min Wang & Hyun Kook Lim

  3. Department of Psychiatry, Seoul St. Mary’s Hospital, College of Medicine, The Catholic University of Korea, Seoul, Republic of Korea

    Dong Woo Kang

  4. Department of Psychiatry, Keyo Hospital, Keyo Medical Foundation, Uiwang, Republic of Korea

    Nak-Young Kim

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Contributions

Yoo Hyun Um—data collection, data analysis and interpretation, drafting the article.

Sheng-Min Wang—critical revision of the article, final approval of the version to be published.

Dong Woo Kang—critical revision of the article, final approval of the version to be published.

Nak-Young Kim—critical revision of the article, final approval of the version to be published.

Hyun Kook Lim—conception, design of the work, critical revision of the article, final approval of the version to be published.

Corresponding author

Correspondence to Hyun Kook Lim.

Ethics declarations

Ethics approval

All study procedures were conducted under the approval by the Institutional Review Board (IRB) of the St. Vincent’s Hospital, the Catholic University of Korea. Moreover, this clinical trial was approved by the Korean MFDS (Ministry of Food and Drug Safety). The study was performed in accordance with the ethical standards as laid down in the 1964 Declaration of Helsinki and its later amendments.

Consent to participate.

Informed consent to participate in the study was obtained from all participants in the study.

Consent for publication.

Informed consent to publish the results from the study was obtained from all participants in the study.

Conflict of interest

The authors declare no competing interests.

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Um, Y.H., Wang, SM., Kang, D.W. et al. Impact of transdermal trigeminal electrical neuromodulation on subjective and objective sleep parameters in patients with insomnia: a pilot study. Sleep Breath 26, 865–870 (2022). https://doi.org/10.1007/s11325-021-02459-0

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  • DOI: https://doi.org/10.1007/s11325-021-02459-0

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