Validation of Therapeutic Effects of Cefaly on Insomnia

NCT04838067 | Completed DMC

• 1 other identifier: VC18DNSI0145
• Study Type: interventional
• Target: 19
• Locations: 1 country
• Sites: 1

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

Conditions

Sleep Initiation and Maintenance Disorders

Outcome Measures

Primary Outcomes (16)

• Pittsburgh sleep quality index(PSQI)

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

  4 weeks after intervention

• Insomnia severity index(ISI)

  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)

  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)

  Changes in Total sleep time

  4 weeks after intervention

• Polysomnography measures-2 (Wake after sleep onset)

  Changes in Wake after sleep onset

  4 weeks after intervention

• Polysomnography measures-3( Stage 1 sleep period)

  Changes in Stage 1 sleep period

  4 weeks after intervention

• Polysomnography measures-4(Stage 2 sleep period)

  Changes in Stage 2 sleep period

  4 weeks after intervention

• Polysomnography measures-5(Stage 3 sleep period)

  Changes in Stage 3 sleep period

  4 weeks after intervention

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

  Changes in Total rapid eye movement sleep period

  4 weeks after intervention

• Polysomnography measures-7(Rapid eye movement sleep latency)

  Changes in Rapid eye movement sleep latency

  4 weeks after intervention

• Polysomnography measures-8(Sleep latency)

  Changes in Sleep latency

  4 weeks after intervention

• Polysomnography measures-9(Apnea hypopnea index)

  Changes in Apnea hypopnea index

  4 weeks after intervention

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

  Resting state network functional connectivity changes

  4 weeks after intervention

• Neuroimaging parameter changes-2(Cortical thickness)

  Changes in Cortical thickness

  4 weeks after intervention

• Neuroimaging parameter changes-4(Fractional anisotropy)

  Changes in Fractional anisotropy

  4 weeks after intervention

• Neuroimaging parameter changes-5(Mean diffusivity)

  Changes in Mean diffusivity

  4 weeks after intervention

Study Arms (1)

Cefaly Intervention

EXPERIMENTAL

Cefaly

Device: Cefaly

Interventions

Cefaly DEVICE

Transcutaneous trigeminal nerve electrical neuromodulation

Cefaly Intervention

Eligibility Criteria

• Age: 19 Years - 64 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64)

You may qualify if:

• 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

You may not qualify if:

• 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.

Sponsors & Collaborators

• Saint Vincent's Hospital, Korea: lead

Study Sites (1)

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

Suwon, South Korea

Location

Related Publications (2)

• 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.

  PMID: 35619611 DERIVED

• 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.

  PMID: 34383274 DERIVED

MeSH Terms

Conditions

Sleep Initiation and Maintenance Disorders

Condition Hierarchy (Ancestors)

Sleep Disorders, Intrinsic; Dyssomnias; Sleep Wake Disorders; Nervous System Diseases; Mental Disorders

Study Officials

• Se-Min Choung

  CMC IRB

  STUDY DIRECTOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NA
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Clinical Assistant Professor

Study Record Dates

• First Submitted: April 4, 2021
• First Posted: April 8, 2021
• Study Start: July 26, 2018
• Primary Completion: April 7, 2020
• Study Completion: July 14, 2020
• Last Updated: April 8, 2021

Record last verified: 2021-04

Locations

KR (1)