Determining the effect of Vagus nerve stimulation on total sleep time, sleep quality, insomnia severity and actigraphy in primary insomnia patients
Design
Parallel group randomized trial, double blinded and Sham controlled and 35 sample size
Settings and conduct
In this double blinded randomized clinical trial, we give primary insomnia patients taVNS intervention. Patients get it for 4 weeks daily, with 20 Hz frequency and 2 times a day, each time 20 minutes. One electrode is attached to right ear concha and the other to the other shoulder. We evaluate sleep quality and insomnia severity using questionaries and Actigraphy at the beginning of the study and each weak after the that.
Location of the intervention: At first 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.
Participants/Inclusion and exclusion criteria
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 groups
Intervention group: 35 people, electric stimulation in concha of the ear
Control group: 35 people, electric stimulation in margin of the ear
Main outcome variables
duration of sleep, quality of sleep, insomnia severity
General information
Reason for update
Acronym
IRCT registration information
IRCT registration number:IRCT20230812059131N1
Registration date:2023-09-24, 1402/07/02
Registration timing:prospective
Last update:2023-09-24, 1402/07/02
Update count:1
Registration date
2023-09-24, 1402/07/02
Registrant information
Name
Arian Hasani
Name of organization / entity
Country
Iran (Islamic Republic of)
Phone
+98 21 3660 1419
Email address
a-hasani@student.tums.ac.ir
Recruitment status
Recruitment complete
Funding source
Expected recruitment start date
2023-10-23, 1402/08/01
Expected recruitment end date
2024-10-22, 1403/08/01
Actual recruitment start date
empty
Actual recruitment end date
empty
Trial completion date
empty
Scientific title
Effect of auricular vagus nerve stimulation on total sleep time, sleep quality, insomnia severity and actigraphy in primary insomnia patients
Public title
Effect of auricular vagus nerve stimulation on sleep
Purpose
Treatment
Inclusion/Exclusion criteria
Inclusion criteria:
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
Exclusion criteria:
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
Age
From 18 years old to 70 years old
Gender
Both
Phase
N/A
Groups that have been masked
Participant
Care provider
Investigator
Outcome assessor
Sample size
Target sample size:
35
Randomization (investigator's opinion)
Randomized
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 (investigator's opinion)
Double blinded
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.
Placebo
Used
Assignment
Parallel
Other design features
Secondary Ids
empty
Ethics committees
1
Ethics committee
Name of ethics committee
Ethics committee of Tehran University of Medical Sciences
Street address
Room 604, sixth floor, central building of Tehran university of medical sciences, Keshavarz Blvd, Tehran, Iran
City
Tehran
Province
Tehran
Postal code
1417614411
Approval date
2023-07-11, 1402/04/20
Ethics committee reference number
IR.TUMS.NI.REC.1402.016
Health conditions studied
1
Description of health condition studied
Primary Insomnia
ICD-10 code
F51.01
ICD-10 code description
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
Primary outcomes
1
Description
Duration of sleep
Timepoint
Measuring sleep duration from the beginning till the end of the intervention (everyday for a month)
Method of measurement
Actigraphy device
2
Description
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
3
Description
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)
Secondary outcomes
empty
Intervention groups
1
Description
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.
Category
Treatment - Devices
2
Description
Control group: In this study, patients in control receive electric stimulation in concha 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.