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

Status

Recruiting

Phases

Unknown

Study type

Interventional

Source

IRCT

Registry ID

IRCT20230812059131N1

Enrollment

Registered

2023-09-24

Start date

2024-01-21

Completion date

Unknown

Last updated

2024-01-22

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Primary Insomnia. 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

Interventions

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 e

Eligibility

Sex/Gender

All

Age

18 Years to 70 Years

Inclusion 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

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

Design outcomes

Primary

Measure	Time frame
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).	—

Measure

Time frame

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).

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Countries

Iran (Islamic Republic of)

Contacts

Public ContactArian Hasani

Tehran University of Medical Sciences

a-Hasani@student.tums.ac.ir+98 21 3660 1419

Outcome results

None listed

Source: IRCT (via WHO ICTRP) · Data processed: Feb 4, 2026