Trial reportSleep & breathing = Schlaf & Atmung2022
Impact of transdermal trigeminal electrical neuromodulation on subjective and objective sleep parameters in patients with insomnia: a pilot study.
Trial report in Sleep & breathing = Schlaf & Atmung, 2022. The graph could read no effect estimate from its abstract, so it casts no vote on the map. It is linked to trial NCT04838067 (Validation of Therapeutic Effects of Cefaly on Insomnia by Neuroimaging and Polysomnography Analyses), which is not on this map. Cited by 5 papers, 1 of them a synthesis that pooled it.
What it found
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The abstract states no effect estimate the extractor could read, or names no intervention and outcome on the map, so this paper lights no cell and moves no belief. It is still indexed, cited and linked below.
The trial behind it
Trials whose registry record cites this paper, or whose number appears in the abstract. A trial that started after this paper was published is citing it as background, not reporting it.
Validation of Therapeutic Effects of Cefaly on Insomnia by Neuroimaging and Polysomnography Analyses: a Single Site, Single-armed Exploratory Study
Who cites it
5 citing papers in PubMed, 1 synthesis or guideline pooled it, 6 citations in OpenAlex.
- Clinical and cognitive effects of external trigeminal nerve stimulation (eTNS) in neurological and psychiatric disorders: a systematic review and meta-analysis.Molecular psychiatry · 2023Pooled it
- Efficacy of electrical vestibular stimulation (VeNS) on adults with insomnia: A double-blind, randomized, sham-controlled trial.Dialogues in clinical neuroscience · 2025Trial
- External trigeminal nerve stimulation for neuropsychiatric disorders: mechanisms, efficacy, and future directions.Frontiers in neurology · 2025Review
- Clinical Spectrum and Trajectory of Innovative Therapeutic Interventions for Insomnia: A Perspective.Aging and disease · 2023Article
- Alterations of Resting-State Locus Coeruleus Functional Connectivity After Transdermal Trigeminal Electrical Neuromodulation in Insomnia.Frontiers in psychiatry · 2022Article
Corrections and comments
PubMed lists nothing against this paper. Absence here is not a guarantee, only a check that was made.
Authors and funding
5 authors at 4 institutions in 1 country.
Funding
No grant is acknowledged in the PubMed record.
Abstract
purposeTranscutaneous 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.
methodsIn 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.
resultsAmong 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.
conclusionThis 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 registrationThe 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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Registered trials
Read under generation 80e0d062 · epoch 390. Bibliography from PubMed, PubMed Central and OpenAlex; grants from NIH RePORTER; trial links from ClinicalTrials.gov; estimates, votes and beliefs from the OpenQuestion graph.