Effect of auricular vagus nerve stimulation on total sleep time, sleep quality, insomnia severity and sleep log in primary insomnia patients

Determining the effect of Vagus nerve stimulation on total sleep time, sleep quality, insomnia severity and sleep log in primary insomnia patients

Parallel group randomized trial, double blinded and Sham controlled and 25 sample size

In this double blinded randomized clinical trial, we give insomnia patients taVNS intervention. After one week of completing sleep-log, patients get it for 4 weeks daily, with 20 Hz frequency and 2 times a day for 20 minutes. One electrode is attached to left ear concha and the other to the left shoulder. Questionaries and sleep log are measured at the beginning and the end of the study. Location of the intervention: We explain about the intervention and the device to the patients and the they do it in their house every day. Blinding: patients and people who involve in follow up and data gathering are blind. The researcher who explains intervention to the patient and knows the patient's group, does not cooperate in the study.

Inclusion criteria: Age between 18 and 70, right-handed, diagnosed as primary insomnia with at least one of the symptoms of insomnia (1.problem with falling asleep, 2. problem with maintaining sleep, 3.sleep deprivation) for at least 3 months, PSQI sleep quality equal or more than 7 Exclusion criteria: History of head injury, Nervous system disorder, Drug abuse, Critical primary endocrine, cardiovascular, blood or psychiatry disease, Contraindications for taVNS intervention like asthma and cardiac arrhythmias, Use of hypnotic drugs, Use of psychiatric drugs, Pregnancy or lactation

Intervention group: 25 people, electric stimulation in concha of the ear Control group: 25 people, electric stimulation in earlobe of the ear

duration of sleep, sleep quality ,fatigue and insomnia severity, depression and anxiety severity

1. Changing sample size from 70 to 50 (Because of the number of available taVNS devices, which was lower than we thought, current sample size would make our study really long and frustrating that can make different kinds of biases) 2. Changing the Actigraphy outcome to sleep-log graph (Because of incomplete provision of Actigraphy devices with sufficient quality from the manufacturer company, we substituted it with sleep-log graph as another quantitive method for examining patients' daily sleep time) 3. Changing the location of electrodes in control group from margin of the ear to the earlobe (based on our latest literature review, earlobe is a more reliable region than ear margin for the control group)

In this study, allocation will be done into two groups of intervention and control. The tool of allocation will be "www.sealed envelope.com" and the ratio of allocation is 1:1. The type of allocation is complete (simple) and the unit of allocation is each patient.

Both patients and people who follow up the patients and retrieve their data, are blinded regarding the patient's intervention. In order to achieve this, the researcher who explains the patient how to use the device and knows the location of electrode and the group of each patient (control or intervention), does not cooperate in any of the future steps of the study like follow ups or data analysis.

Publishing the results of the study in the form of medical doctor thesis and a study in international journals

After the defense session of the thesis

For general population

Other researchers

Arian Hasani Address: No 19, First alley, Northern Naft St, Mirdamad, Tehran, Iran Email address: a-Hasani@student.tums.ac.ir Emergent number: +989390348543 Hamed Amiri fard Address: Neurology building, Northern door of Imam Khomeini hospital, Eastern Bagher khan St, Chamran highway, Tehran, Iran Email address: dr.amirifard@gmail.com Emergent number: 02161192053

After confirmation by the responsible authorities