Validation of Therapeutic Effects of Cefaly on Insomnia
6. april 2021 oppdatert av: 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
Studieoversikt
Status
Fullført
Intervensjon / Behandling
Detaljert 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).
Studietype
Intervensjonell
Registrering (Faktiske)
19
Fase
- Ikke aktuelt
Kontakter og plasseringer
Denne delen inneholder kontaktinformasjon for de som utfører studien, og informasjon om hvor denne studien blir utført.
Studiesteder
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Suwon, Korea, Republikken
- St.Vincent's Hospital, the Catholic University of Korea
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Deltakelseskriterier
Forskere ser etter personer som passer til en bestemt beskrivelse, kalt kvalifikasjonskriterier. Noen eksempler på disse kriteriene er en persons generelle helsetilstand eller tidligere behandlinger.
Kvalifikasjonskriterier
Alder som er kvalifisert for studier
19 år til 64 år (Voksen)
Tar imot friske frivillige
Nei
Kjønn som er kvalifisert for studier
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
Denne delen gir detaljer om studieplanen, inkludert hvordan studien er utformet og hva studien måler.
Hvordan er studiet utformet?
Designdetaljer
- Primært formål: Behandling
- Tildeling: N/A
- Intervensjonsmodell: Enkeltgruppeoppdrag
- Masking: Ingen (Open Label)
Våpen og intervensjoner
Deltakergruppe / Arm |
Intervensjon / Behandling |
|---|---|
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Eksperimentell: Cefaly Intervention
Cefaly
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Transcutaneous trigeminal nerve electrical neuromodulation
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Hva måler studien?
Primære resultatmål
Resultatmål |
Tiltaksbeskrivelse |
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
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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.
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4 weeks after intervention
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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.
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4 weeks after intervention
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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
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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
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Changes in Stage 3 sleep period
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4 weeks after intervention
|
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Polysomnography measures-6(Total rapid eye movement sleep period)
Tidsramme: 4 weeks after intervention
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Changes in Total rapid eye movement sleep period
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4 weeks after intervention
|
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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
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Changes in Mean diffusivity
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4 weeks after intervention
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Samarbeidspartnere og etterforskere
Det er her du vil finne personer og organisasjoner som er involvert i denne studien.
Sponsor
Etterforskere
- Studieleder: Se-Min Choung, CMC IRB
Publikasjoner og nyttige lenker
Den som er ansvarlig for å legge inn informasjon om studien leverer frivillig disse publikasjonene. Disse kan handle om alt relatert til studiet.
Generelle publikasjoner
- 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.
Studierekorddatoer
Disse datoene sporer fremdriften for innsending av studieposter og sammendragsresultater til ClinicalTrials.gov. Studieposter og rapporterte resultater gjennomgås av National Library of Medicine (NLM) for å sikre at de oppfyller spesifikke kvalitetskontrollstandarder før de legges ut på det offentlige nettstedet.
Studer hoveddatoer
Studiestart (Faktiske)
26. juli 2018
Primær fullføring (Faktiske)
7. april 2020
Studiet fullført (Faktiske)
14. juli 2020
Datoer for studieregistrering
Først innsendt
4. april 2021
Først innsendt som oppfylte QC-kriteriene
6. april 2021
Først lagt ut (Faktiske)
8. april 2021
Oppdateringer av studieposter
Sist oppdatering lagt ut (Faktiske)
8. april 2021
Siste oppdatering sendt inn som oppfylte QC-kriteriene
6. april 2021
Sist bekreftet
1. april 2021
Mer informasjon
Begreper knyttet til denne studien
Ytterligere relevante MeSH-vilkår
Andre studie-ID-numre
- VC18DNSI0145
Legemiddel- og utstyrsinformasjon, studiedokumenter
Studerer et amerikansk FDA-regulert medikamentprodukt
Nei
Studerer et amerikansk FDA-regulert enhetsprodukt
Nei
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