Validation of Therapeutic Effects of Cefaly on Insomnia

Sleep Initiation and Maintenance Disorders Clinical Trial

Official title:

Validation of Therapeutic Effects of Cefaly on Insomnia by Neuroimaging and Polysomnography Analyses: a Single Site, Single-armed Exploratory Study

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT04838067
• Other study ID #: VC18DNSI0145
• Status: Completed
• Phase: N/A
• Start date: July 26, 2018
• Est. completion date: July 14, 2020

Study information

• Verified date: April 2021
• Source: Saint Vincent's Hospital, Korea
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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

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).

Recruitment information / eligibility

• Status: Completed
• Enrollment: 19
• Est. completion date: July 14, 2020
• Est. primary completion date: April 7, 2020
• Accepts healthy volunteers: No
• Gender: All
• Age group: 19 Years to 64 Years

Eligibility

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.

Related Conditions & MeSH terms

• Sleep Initiation and Maintenance Disorders

Intervention

Device:
• Cefaly
Transcutaneous trigeminal nerve electrical neuromodulation

Locations

Country	Name	City	State
Korea, Republic of	St.Vincent's Hospital, the Catholic University of Korea	Suwon

Sponsors (1)

Lead Sponsor	Collaborator
Saint Vincent's Hospital, Korea

Country where clinical trial is conducted

Korea, Republic of, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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
Primary	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
Primary	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
Primary	Polysomnography measures-1 (Total sleep time)	Changes in Total sleep time	4 weeks after intervention
Primary	Polysomnography measures-2 (Wake after sleep onset)	Changes in Wake after sleep onset	4 weeks after intervention
Primary	Polysomnography measures-3( Stage 1 sleep period)	Changes in Stage 1 sleep period	4 weeks after intervention
Primary	Polysomnography measures-4(Stage 2 sleep period)	Changes in Stage 2 sleep period	4 weeks after intervention
Primary	Polysomnography measures-5(Stage 3 sleep period)	Changes in Stage 3 sleep period	4 weeks after intervention
Primary	Polysomnography measures-6(Total rapid eye movement sleep period)	Changes in Total rapid eye movement sleep period	4 weeks after intervention
Primary	Polysomnography measures-7(Rapid eye movement sleep latency)	Changes in Rapid eye movement sleep latency	4 weeks after intervention
Primary	Polysomnography measures-8(Sleep latency)	Changes in Sleep latency	4 weeks after intervention
Primary	Polysomnography measures-9(Apnea hypopnea index)	Changes in Apnea hypopnea index	4 weeks after intervention
Primary	Neuroimaging parameter changes-1(Resting state network functional connectivity)	Resting state network functional connectivity changes	4 weeks after intervention
Primary	Neuroimaging parameter changes-2(Cortical thickness)	Changes in Cortical thickness	4 weeks after intervention
Primary	Neuroimaging parameter changes-4(Fractional anisotropy)	Changes in Fractional anisotropy	4 weeks after intervention
Primary	Neuroimaging parameter changes-5(Mean diffusivity)	Changes in Mean diffusivity	4 weeks after intervention