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IRCT20230812059131N1 IRCT 2023-09-24 Neurology research center of Imam khomeini hospital Effect of auricular vagus nerve stimulation on sleep Effect of auricular vagus nerve stimulation on total sleep time, sleep quality, insomnia severity and sleep log in primary insomnia patients 2024-01-21 anticipated 25 Complete https://irct.ir/trial/72385 interventional Randomization: Randomized, Blinding: Double blinded, Placebo: Used, Assignment: Parallel, Purpose: Treatment, Randomization description: 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, Blinding description: 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. N/A Primary Insomnia. Intervention 1: Intervention group: In this study, patients in intervention group receive electric stimulation in concha region of the ear (enervated by Vagus nerve). One electrode is placed in left ear concha in the form of a clip and the other one is placed behind the shoulder in the form of a pad. Intervention 2: Control group: In this study, patients in control receive electric stimulation in earlobe region of the ear (non-enervated by Vagus nerve). One electrode is placed in left ear concha in the form of a clip and the other one is placed behind the shoulder in the form of a pad. Yes - There is a plan to make this available What will be shared: Publishing the results of the study in the form of medical doctor thesis and a study in international journals When: After the defense session of the thesis To whom: For general population Conditions: Other researchers Where to obtain: 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 How to obtain: After confirmation by the responsible authorities Comments:
public Arian Hasani
No 19, first alley, northern Naft St, mirdamad Blvd, Tehran, Iran
Tehran Iran (Islamic Republic of) 1761835411 +98 21 3660 1419 a-Hasani@student.tums.ac.ir Tehran University of Medical Sciences scientific Arian Hasani
No 19, first alley, northern Naft St, mirdamad Blvd, Tehran, Iran
Tehran Iran (Islamic Republic of) 1761835411 +98 21 3660 1419 a-Hasani@student.tums.ac.ir Tehran University of Medical Sciences Iran (Islamic Republic of) Age between 18 and 70 Being right-handed Being diagnosed as primary insomnia with at least one out of three symptoms of primary insomnia (1.problem with falling asleep, 2problem with maintaining sleep, 3.sleep deprivation) for at least 3 months PSQI sleep quality equal or more than 7 18 years 70 years Both History of head injury Nervous system disorder Drug abuse Critical primary disease in endocrine system, cardiovascular system, blood and psychiatry Having contraindications for taVNS intervention like asthma and cardiac arrhythmias Use of hypnotic drugs Use of psychiatric drugs Pregnancy or lactation F51.01 A condition of unsatisfactory quantity and/or quality of sleep, which persists for a considerable period of time, including difficulty falling asleep, difficulty staying asleep, or early final wakening. Insomnia is a common symptom of many mental and phys Treatment - Devices Treatment - Devices Intervention group: In this study, patients in intervention group receive electric stimulation in concha region of the ear (enervated by Vagus nerve). One electrode is placed in left ear concha in the form of a clip and the other one is placed behind the shoulder in the form of a pad. Control group: In this study, patients in control receive electric stimulation in earlobe region of the ear (non-enervated by Vagus nerve). One electrode is placed in left ear concha in the form of a clip and the other one is placed behind the shoulder in the form of a pad. Duration of sleep. Timepoint: Measuring sleep duration from the beginning till the end of the intervention (everyday for a month). Method of measurement: sleep log chart. Sleep quality. Timepoint: Measured in the beginning and the end of the study (beginning and end of the one month duration of the intervention). Method of measurement: Pittsburgh Sleep Quality Index (PSQI) questionary. Insomnia severity. Timepoint: Measured in the beginning and the end of the study (beginning and end of the one month duration of the intervention). Method of measurement: Insomnia severity index (ISI). Fatigue severity. Timepoint: Measured in the beginning and the end of the study (beginning and end of the one month duration of the intervention). Method of measurement: Epworth sleepiness scale (ESS). Depression severity. Timepoint: Measured in the beginning and the end of the study (beginning and end of the one month duration of the intervention). Method of measurement: Hamilton Rating Scale for Depression (HAMD). Anxiety severity. Timepoint: Measured in the beginning and the end of the study (beginning and end of the one month duration of the intervention). Method of measurement: Hamilton Rating Scale for Anxiety (HAMA). Neurology research center of Imam khomeini hospital Approved 2023-07-11 Ethics committee of Tehran University of Medical Sciences Room 604, sixth floor, central building of Tehran university of medical sciences, Keshavarz Blvd, Tehran, Iran Tehran Tehran Iran (Islamic Republic of)