Sleep Initiation and Maintenance Disorders
Conditions
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).
Interventions
DEVICECefaly
Transcutaneous trigeminal nerve electrical neuromodulation
Sponsors
Saint Vincent's Hospital, Korea
Study design
Allocation
NA
Intervention model
SINGLE_GROUP
Primary purpose
TREATMENT
Masking
NONE
Eligibility
Sex/Gender
ALL
Age
19 Years to 64 Years
Healthy volunteers
No
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.
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Polysomnography measures-5(Stage 3 sleep period) | 4 weeks after intervention | Changes in Stage 3 sleep period |
| Pittsburgh sleep quality index(PSQI) | 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. |
| Insomnia severity index(ISI) | 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. |
| Epworth sleepiness scale(ESS) | 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. |
| Polysomnography measures-1 (Total sleep time) | 4 weeks after intervention | Changes in Total sleep time |
| Polysomnography measures-2 (Wake after sleep onset) | 4 weeks after intervention | Changes in Wake after sleep onset |
| Polysomnography measures-3( Stage 1 sleep period) | 4 weeks after intervention | Changes in Stage 1 sleep period |
| Polysomnography measures-4(Stage 2 sleep period) | 4 weeks after intervention | Changes in Stage 2 sleep period |
| Polysomnography measures-6(Total rapid eye movement sleep period) | 4 weeks after intervention | Changes in Total rapid eye movement sleep period |
| Polysomnography measures-7(Rapid eye movement sleep latency) | 4 weeks after intervention | Changes in Rapid eye movement sleep latency |
| Polysomnography measures-8(Sleep latency) | 4 weeks after intervention | Changes in Sleep latency |
| Polysomnography measures-9(Apnea hypopnea index) | 4 weeks after intervention | Changes in Apnea hypopnea index |
| Neuroimaging parameter changes-1(Resting state network functional connectivity) | 4 weeks after intervention | Resting state network functional connectivity changes |
| Neuroimaging parameter changes-2(Cortical thickness) | 4 weeks after intervention | Changes in Cortical thickness |
| Neuroimaging parameter changes-4(Fractional anisotropy) | 4 weeks after intervention | Changes in Fractional anisotropy |
| Neuroimaging parameter changes-5(Mean diffusivity) | 4 weeks after intervention | Changes in Mean diffusivity |
Countries
South Korea
Outcome results
None listed