Clinical trial NCT04838067: Validation of Therapeutic Effects of Cefaly on Insomnia
Official title: Validation of Therapeutic Effects of Cefaly on Insomnia by Neuroimaging and Polysomnography Analyses: a Single Site, Single-armed Exploratory Study
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Sleep Initiation and Maintenance Disorders
Lead sponsor: Saint Vincent's Hospital, Korea
Sponsor class: OTHER
First posted: 2021-04-08
Enrollment: 19
Sex: ALL
Minimum age (years): 19
Maximum age (years): 64
Standard ages: ADULT
Accepts healthy volunteers: no
Allocation: NA
Intervention model: SINGLE_GROUP
Primary purpose: TREATMENT

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

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).

Eligibility 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.

Primary outcomes:
measure: Pittsburgh sleep quality index(PSQI)
timeFrame: 4 weeks after intervention
measure: Insomnia severity index(ISI)
timeFrame: 4 weeks after intervention
measure: Epworth sleepiness scale(ESS)
timeFrame: 4 weeks after intervention
measure: Polysomnography measures-1 (Total sleep time)
timeFrame: 4 weeks after intervention
measure: Polysomnography measures-2 (Wake after sleep onset)
timeFrame: 4 weeks after intervention
measure: Polysomnography measures-3( Stage 1 sleep period)
timeFrame: 4 weeks after intervention
measure: Polysomnography measures-4(Stage 2 sleep period)
timeFrame: 4 weeks after intervention
measure: Polysomnography measures-5(Stage 3 sleep period)
timeFrame: 4 weeks after intervention
measure: Polysomnography measures-6(Total rapid eye movement sleep period)
timeFrame: 4 weeks after intervention
measure: Polysomnography measures-7(Rapid eye movement sleep latency)
timeFrame: 4 weeks after intervention
measure: Polysomnography measures-8(Sleep latency)
timeFrame: 4 weeks after intervention
measure: Polysomnography measures-9(Apnea hypopnea index)
timeFrame: 4 weeks after intervention
measure: Neuroimaging parameter changes-1(Resting state network functional connectivity)
timeFrame: 4 weeks after intervention
measure: Neuroimaging parameter changes-2(Cortical thickness)
timeFrame: 4 weeks after intervention
measure: Neuroimaging parameter changes-4(Fractional anisotropy)
timeFrame: 4 weeks after intervention
measure: Neuroimaging parameter changes-5(Mean diffusivity)
timeFrame: 4 weeks after intervention
Secondary outcomes:
Other outcomes:
Locations:
city: Suwon
country: Korea, Republic of
facility: St.Vincent's Hospital, the Catholic University of Korea
Study officials:
affiliation: CMC IRB
name: Se-Min Choung
role: STUDY_DIRECTOR
References:
citation: 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.
citation: 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.