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Validation of Therapeutic Effects of Cefaly on Insomnia

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ClinicalTrials.gov Identifier: NCT04838067
Recruitment Status : Completed
First Posted : April 8, 2021
Last Update Posted : April 8, 2021
Sponsor:
Information provided by (Responsible Party):
Yoo Hyun Um, Saint Vincent's Hospital, Korea

Study Description
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Brief Summary:
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

Condition or disease Intervention/treatment Phase
Sleep Initiation and Maintenance Disorders Device: Cefaly Not Applicable

Detailed Description:
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).
Study Design
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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 19 participants
Allocation: N/A
Intervention Model: Single Group Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Official Title: Validation of Therapeutic Effects of Cefaly on Insomnia by Neuroimaging and Polysomnography Analyses: a Single Site, Single-armed Exploratory Study
Actual Study Start Date : July 26, 2018
Actual Primary Completion Date : April 7, 2020
Actual Study Completion Date : July 14, 2020
Arms and Interventions
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Arm Intervention/treatment
Experimental: Cefaly Intervention
Cefaly
 Device: Cefaly
Transcutaneous trigeminal nerve electrical neuromodulation


Outcome Measures
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Primary Outcome Measures :
  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


Eligibility Criteria
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Ages Eligible for Study:   19 Years to 64 Years   (Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

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

Exclusion Criteria:

  1. Cognitive impairment
  2. Psychiatric disorders or neurological disorders.
  3. Unstable medical conditions
  4. Prior diagnosis of sleep disorders
  5. Hypnotic prescription
  6. History of brain or facial trauma within 3 months
  7. Skin abrasions
  8. Acrylic acid allergy
  9. Electromagnetic hypersensitivity
  10. Apnea hypopnea index of >15/hour in the baseline polysomnography.
Contacts and Locations
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Information from the National Library of Medicine

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): NCT04838067


Locations
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Korea, Republic of
St.Vincent's Hospital, the Catholic University of Korea
Suwon, Korea, Republic of
Sponsors and Collaborators
Saint Vincent's Hospital, Korea
Investigators
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Study Director: Se-Min Choung CMC IRB
  Study Documents (Full-Text)

Documents provided by Yoo Hyun Um, Saint Vincent's Hospital, Korea:
Statistical Analysis Plan  [PDF] April 3, 2021

More Information
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Publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):

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Responsible Party: Yoo Hyun Um, Clinical Assistant Professor, Saint Vincent's Hospital, Korea
ClinicalTrials.gov Identifier: NCT04838067    
Other Study ID Numbers: VC18DNSI0145
First Posted: April 8, 2021    Key Record Dates
Last Update Posted: April 8, 2021
Last Verified: April 2021

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
Additional relevant MeSH terms:
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Sleep Initiation and Maintenance Disorders
Sleep Disorders, Intrinsic
Dyssomnias
 Sleep Wake Disorders
Nervous System Diseases
Mental Disorders