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Completed

NCT Number: NCT04838067

Validation of Therapeutic Effects of Cefaly on Insomnia

The study aims to examine whether the Cefaly has a therapeutic effect on insomnia patients visiting a psychiatric clinic in Korea. The study design is a single site, single-armed exploratory study. Insomnia patients received a 20-minute daily sessions of the Cefaly for 4 weeks. Primary endpoint was a reduction of scores in Pittsburgh Sleep Quality Index, Insomnia Severity Index, Epworth Sleepiness Scale, improvements in polysomnography measures, and changes in resting state networks, cortical thickness, fractional anisotropy and mean diffusivity

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Key information

Conditions

Sleep Initiation and Maintenance Disorders Dyssomnias Mental Disorders Nervous System Diseases Sleep Disorders, Intrinsic Sleep Wake Disorders

Age range

19 year–64 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

St.Vincent's Hospital, the Catholic University of Korea

Suwon, South Korea

About this study

Insomnia is well-known for its association with adverse health outcomes. Although insomnia is usually treated with hypnotics or cognitive behavioral therapy for insomnia, the need for novel nonpharmacological treatment for insomnia is increasing emphasized due to reports of side effects and detrimental consequences of hypnotics. Trigeminal nerve electrical neuromodulation has been suggested as a potential treatment modality through its modulation of noradrenergic activity that results in promoting relaxation and reducing hyperarousal. Insomnia patients enrolled in the study will go through a 20-minute daily session of the Cefaly device(originally FDA-approved device for migraine, which electrically modulates trigeminal nerve) for 4 weeks. The objective of this study is to test whether trigeminal nerve electrical neuromodulation has a therapeutic effect, validation measures involving subjective measures(Pittsburgh Sleep Quality Index, Insomnia Severity Index, Epworth Sleepiness Scale), objective measures(Polysomnography measures) and neuroimaging(changes in resting state networks, cortical thickness, fractional anisotropy and mean diffusivity).

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

  • Patients who have adequately understood the whole study procedures within age range of 19-64 years
  • Patients with insomnia severity index (ISI) score of more than 15

Exclusion criteria

  • Cognitive impairment
  • Psychiatric disorders or neurological disorders.
  • Unstable medical conditions
  • Prior diagnosis of sleep disorders
  • Hypnotic prescription
  • History of brain or facial trauma within 3 months
  • Skin abrasions
  • Acrylic acid allergy
  • Electromagnetic hypersensitivity
  • Apnea hypopnea index of >15/hour in the baseline polysomnography.

Treatment and study plan

CEFALY

Device

Transcutaneous trigeminal nerve electrical neuromodulation

Primary outcomes

  1. Pittsburgh sleep quality index(PSQI)

    Time frame: 4 weeks after intervention

    Changes in Pittsburgh sleep quality index scores PSQI global score of more than 5 signifies major sleep disturbance, higher scores suggesting greater sleep disturbance.

  2. Insomnia severity index(ISI)

    Time frame: 4 weeks after intervention

    Changes in Insomnia severity index scores ISI is a brief, self-rated scale that is widely used to measure insomnia severity. With seven items scored on a 0-4 scale, it only takes about 5 minutes to complete and scores of 15 or more indicates insomnia of moderate to severe severity.

  3. Epworth sleepiness scale(ESS)

    Time frame: 4 weeks after intervention

    Changes in Epworth sleepiness scale scores Score of more than 10 signifies clinically meaningful daytime sleepiness, with higher scores indicating more severe sleepiness.

  4. Polysomnography measures-1 (Total sleep time)

    Time frame: 4 weeks after intervention

    Changes in Total sleep time

  5. Polysomnography measures-2 (Wake after sleep onset)

    Time frame: 4 weeks after intervention

    Changes in Wake after sleep onset

  6. Polysomnography measures-3( Stage 1 sleep period)

    Time frame: 4 weeks after intervention

    Changes in Stage 1 sleep period

  7. Polysomnography measures-4(Stage 2 sleep period)

    Time frame: 4 weeks after intervention

    Changes in Stage 2 sleep period

  8. Polysomnography measures-5(Stage 3 sleep period)

    Time frame: 4 weeks after intervention

    Changes in Stage 3 sleep period

  9. Polysomnography measures-6(Total rapid eye movement sleep period)

    Time frame: 4 weeks after intervention

    Changes in Total rapid eye movement sleep period

  10. Polysomnography measures-7(Rapid eye movement sleep latency)

    Time frame: 4 weeks after intervention

    Changes in Rapid eye movement sleep latency

  11. Polysomnography measures-8(Sleep latency)

    Time frame: 4 weeks after intervention

    Changes in Sleep latency

  12. Polysomnography measures-9(Apnea hypopnea index)

    Time frame: 4 weeks after intervention

    Changes in Apnea hypopnea index

  13. Neuroimaging parameter changes-1(Resting state network functional connectivity)

    Time frame: 4 weeks after intervention

    Resting state network functional connectivity changes

  14. Neuroimaging parameter changes-2(Cortical thickness)

    Time frame: 4 weeks after intervention

    Changes in Cortical thickness

  15. Neuroimaging parameter changes-4(Fractional anisotropy)

    Time frame: 4 weeks after intervention

    Changes in Fractional anisotropy

  16. Neuroimaging parameter changes-5(Mean diffusivity)

    Time frame: 4 weeks after intervention

    Changes in Mean diffusivity

Sponsors and collaborators

Lead sponsor

Saint Vincent's Hospital, Korea

Other

Registry information

Official study title

Validation of Therapeutic Effects of Cefaly on Insomnia by Neuroimaging and Polysomnography Analyses: a Single Site, Single-armed Exploratory Study

Important dates

Study start
2018
Primary completion
2020
Study completion
2020
First posted
Apr 8, 2021
Registry last updated
Apr 8, 2021

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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