Validation of Therapeutic Effects of Cefaly on Insomnia
6. april 2021 opdateret af: Yoo Hyun Um, Saint Vincent's Hospital, Korea
Validation of Therapeutic Effects of Cefaly on Insomnia by Neuroimaging and Polysomnography Analyses: a Single Site, Single-armed Exploratory Study
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
Studieoversigt
Status
Afsluttet
Betingelser
Intervention / Behandling
Detaljeret beskrivelse
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).
Undersøgelsestype
Interventionel
Tilmelding (Faktiske)
19
Fase
- Ikke anvendelig
Kontakter og lokationer
Dette afsnit indeholder kontaktoplysninger for dem, der udfører undersøgelsen, og oplysninger om, hvor denne undersøgelse udføres.
Studiesteder
-
-
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Suwon, Korea, Republikken
- St.Vincent's Hospital, the Catholic University of Korea
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Deltagelseskriterier
Forskere leder efter personer, der passer til en bestemt beskrivelse, kaldet berettigelseskriterier. Nogle eksempler på disse kriterier er en persons generelle helbredstilstand eller tidligere behandlinger.
Berettigelseskriterier
Aldre berettiget til at studere
19 år til 64 år (Voksen)
Tager imod sunde frivillige
Ingen
Køn, der er berettiget til at studere
Alle
Beskrivelse
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.
Studieplan
Dette afsnit indeholder detaljer om studieplanen, herunder hvordan undersøgelsen er designet, og hvad undersøgelsen måler.
Hvordan er undersøgelsen tilrettelagt?
Design detaljer
- Primært formål: Behandling
- Tildeling: N/A
- Interventionel model: Enkelt gruppeopgave
- Maskning: Ingen (Åben etiket)
Våben og indgreb
Deltagergruppe / Arm |
Intervention / Behandling |
|---|---|
|
Eksperimentel: Cefaly Intervention
Cefaly
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Transcutaneous trigeminal nerve electrical neuromodulation
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Hvad måler undersøgelsen?
Primære resultatmål
Resultatmål |
Foranstaltningsbeskrivelse |
Tidsramme |
|---|---|---|
|
Pittsburgh sleep quality index(PSQI)
Tidsramme: 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.
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4 weeks after intervention
|
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Insomnia severity index(ISI)
Tidsramme: 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.
|
4 weeks after intervention
|
|
Epworth sleepiness scale(ESS)
Tidsramme: 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 weeks after intervention
|
|
Polysomnography measures-1 (Total sleep time)
Tidsramme: 4 weeks after intervention
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Changes in Total sleep time
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4 weeks after intervention
|
|
Polysomnography measures-2 (Wake after sleep onset)
Tidsramme: 4 weeks after intervention
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Changes in Wake after sleep onset
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4 weeks after intervention
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Polysomnography measures-3( Stage 1 sleep period)
Tidsramme: 4 weeks after intervention
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Changes in Stage 1 sleep period
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4 weeks after intervention
|
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Polysomnography measures-4(Stage 2 sleep period)
Tidsramme: 4 weeks after intervention
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Changes in Stage 2 sleep period
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4 weeks after intervention
|
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Polysomnography measures-5(Stage 3 sleep period)
Tidsramme: 4 weeks after intervention
|
Changes in Stage 3 sleep period
|
4 weeks after intervention
|
|
Polysomnography measures-6(Total rapid eye movement sleep period)
Tidsramme: 4 weeks after intervention
|
Changes in Total rapid eye movement sleep period
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4 weeks after intervention
|
|
Polysomnography measures-7(Rapid eye movement sleep latency)
Tidsramme: 4 weeks after intervention
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Changes in Rapid eye movement sleep latency
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4 weeks after intervention
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Polysomnography measures-8(Sleep latency)
Tidsramme: 4 weeks after intervention
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Changes in Sleep latency
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4 weeks after intervention
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Polysomnography measures-9(Apnea hypopnea index)
Tidsramme: 4 weeks after intervention
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Changes in Apnea hypopnea index
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4 weeks after intervention
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Neuroimaging parameter changes-1(Resting state network functional connectivity)
Tidsramme: 4 weeks after intervention
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Resting state network functional connectivity changes
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4 weeks after intervention
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Neuroimaging parameter changes-2(Cortical thickness)
Tidsramme: 4 weeks after intervention
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Changes in Cortical thickness
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4 weeks after intervention
|
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Neuroimaging parameter changes-4(Fractional anisotropy)
Tidsramme: 4 weeks after intervention
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Changes in Fractional anisotropy
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4 weeks after intervention
|
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Neuroimaging parameter changes-5(Mean diffusivity)
Tidsramme: 4 weeks after intervention
|
Changes in Mean diffusivity
|
4 weeks after intervention
|
Samarbejdspartnere og efterforskere
Det er her, du vil finde personer og organisationer, der er involveret i denne undersøgelse.
Sponsor
Efterforskere
- Studieleder: Se-Min Choung, CMC IRB
Publikationer og nyttige links
Den person, der er ansvarlig for at indtaste oplysninger om undersøgelsen, leverer frivilligt disse publikationer. Disse kan handle om alt relateret til undersøgelsen.
Generelle publikationer
- Um YH, Wang SM, Kang DW, Kim NY, Lim HK. Alterations of Resting-State Locus Coeruleus Functional Connectivity After Transdermal Trigeminal Electrical Neuromodulation in Insomnia. Front Psychiatry. 2022 May 10;13:875227. doi: 10.3389/fpsyt.2022.875227. eCollection 2022.
- Um YH, Wang SM, Kang DW, Kim NY, Lim HK. Impact of transdermal trigeminal electrical neuromodulation on subjective and objective sleep parameters in patients with insomnia: a pilot study. Sleep Breath. 2022 Jun;26(2):865-870. doi: 10.1007/s11325-021-02459-0. Epub 2021 Aug 12.
Datoer for undersøgelser
Disse datoer sporer fremskridtene for indsendelser af undersøgelsesrekord og resumeresultater til ClinicalTrials.gov. Studieregistreringer og rapporterede resultater gennemgås af National Library of Medicine (NLM) for at sikre, at de opfylder specifikke kvalitetskontrolstandarder, før de offentliggøres på den offentlige hjemmeside.
Studer store datoer
Studiestart (Faktiske)
26. juli 2018
Primær færdiggørelse (Faktiske)
7. april 2020
Studieafslutning (Faktiske)
14. juli 2020
Datoer for studieregistrering
Først indsendt
4. april 2021
Først indsendt, der opfyldte QC-kriterier
6. april 2021
Først opslået (Faktiske)
8. april 2021
Opdateringer af undersøgelsesjournaler
Sidste opdatering sendt (Faktiske)
8. april 2021
Sidste opdatering indsendt, der opfyldte kvalitetskontrolkriterier
6. april 2021
Sidst verificeret
1. april 2021
Mere information
Begreber relateret til denne undersøgelse
Yderligere relevante MeSH-vilkår
Andre undersøgelses-id-numre
- VC18DNSI0145
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