Study of the Effects of Transcutaneous Auricular Vagus Nerve Stimulation Combined with Slow Breathing on Insomnia

NCT06614803 | Completed

• 1 other identifier: 20240731
• Study Type: interventional
• Target: 80
• Locations: 1 country
• Sites: 1

Brief Summary

The study recruited college students with insomnia disorders and applied transcutaneous auricular vagus nerve stimulation(taVNS) combined with slow breathing. The main aims of the study are: 1) to explore the role of this novel and effective physical therapy technique of taVNS combined with slow breathing in regulating insomnia; 2) to investigate the relationship between the synergistic effect of taVNS and slow breathing on interoceptive indicators and their therapeutic effects.

Conditions

Insomnia

Keywords

Insomnia; Interoception; Transcutaneous Auricular Vagus Nerve Stimulation; Slow Breathing

Outcome Measures

Primary Outcomes (1)

• Sleep diary indicators after two weeks of treatment

  Sleep latency, sleep efficiency, wake time after sleep onset, number of wake times after sleep onset, and total sleep time were used as the primary outcome measure in the sleep diary.

  Sleep diaries were collected daily for five weeks, but changes in sleep diary data were assessed after one week baseline, two weeks of treatment, and two weeks of follow-up.

Secondary Outcomes (7)

• Changes in heart rate variability

  Heart rate variability will be assessed twice within five weeks:at baseline,and after two weeks of treatment.

• Changes in heartbeat evoked potential

  Heartbeat evoked potential will be assessed twice within five weeks:at baseline,and after two weeks of treatment.

• Changes in ISI scores

  ISI will be assessed three times within five weeks: at baseline, after two weeks of treatment, and two weeks of follow-up.

• Changes in PSQI scores

  PSQI will be assessed three times within five weeks: at baseline, after two weeks of treatment, and two weeks of follow-up.

• Change in PHQ-9 scores

  PHQ-9 will be assessed three times within five weeks: at baseline, after two weeks of treatment, and two weeks of follow-up.

Study Arms (4)

taVNS combined with slow breathing

ACTIVE COMPARATOR

For taVNS combined with slow breathing group,after preparing the skin with an alcohol pad, electrodes were attached to the tragus and cymba conchae of the left ear,and under the guidance of the device's video, the participants were instructed to perform six slow and relaxed breaths per minute (0.1Hz), while the built-in parameters of the device delivered stimulation during the 5 seconds of exhalation.The stimulation parameters were set to a burst pulse wave with a frequency of 20Hz, 200μs, and a burst frequency of 2000Hz, 5s ON-5s OFF;stimulation time:20min.

Device: Transcutaneous vagus nerve stimulation combined slow breathing

taVNS with normal breathing

ACTIVE COMPARATOR

For taVNS with normal breathing group,without video guidance on the stimulation device, the participants breathed freely while receiving normal tVNS intervention.Electrodes were attached to the tragus and cymba conchae of the left ear. The stimulation parameters were set to a burst pulse wave with a frequency of 20Hz, 200μs, 5s ON-5s OFF, and a burst frequency of 2000Hz, ;stimulation time:20min.

Device: Transcutaneous vagus nerve stimulation

slow breathing with sham taVNS

ACTIVE COMPARATOR

For slow breathing with sham taVNS group,the participants followed the video instructions to perform slow breathing while wearing the stimulation electrodes, but the device only outputted stimulation for one minute and then stopped.

Device: Transcutaneous vagus nerve stimulation combined slow breathing

normal breathing with sham taVNS

SHAM COMPARATOR

For normal breathing with sham taVNS group,the device were set to output stimulation for only one minute and then stop, and the participants breathed normally

Device: Transcutaneous vagus nerve stimulation

Interventions

Transcutaneous vagus nerve stimulation combined slow breathing DEVICE

The stimulation parameters were set to a burst pulse wave with a frequency of 20Hz, 200μs,5s ON-5s OFF,and a burst frequency of 2000Hz. Electrodes were attached to the tragus and cymba conchae of the left ear,the screen of the device displays slow breathing guidance video at 0.1Hz, while the device delivered stimulation during the 5 seconds of exhalation.

slow breathing with sham taVNS; taVNS combined with slow breathing

Transcutaneous vagus nerve stimulation DEVICE

Without slow breathing guidance video on the stimulation device,the stimulation parameters were set to a burst pulse wave with a frequency of 20Hz, 200μs,5s ON-5s OFF,and a burst frequency of 2000Hz. Electrodes were attached to the tragus and cymba conchae of the left ear

normal breathing with sham taVNS; taVNS with normal breathing

Eligibility Criteria

• Age: 18 Years - 28 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64)

You may qualify if:

• Age over 18 years;
• Meet the definition of insomnia in the Diagnostic and Statistical Manual of Mental Disorders 5th Edition (DSM-V)；
• Has not received any psychotropic drug treatment；
• PSQI(Pittsburgh Sleep Quality Index) score\>7；
• ISI(Insomnia Severity Index) score≥11；
• Signed informed consent form;
• Ability and willingness to comply with the study requirements.

You may not qualify if:

• There are learning or working hours that affect the circadian rhythm;
• There is abuse of alcohol, nicotine, or other substances;
• Pregnancy, breastfeeding, or plans to become pregnant;
• Damage or allergy to the selected stimulation site;
• Clinically diagnosed mental disorders and other medical conditions;
• Currently taking stimulant, hormone, or other medications that may cause insomnia and are not suitable for discontinuation.

Sponsors & Collaborators

• Xidian University: lead

Study Sites (1)

Xidian University

Xi'an, Shaanxi, China

Location

MeSH Terms

Conditions

Sleep Initiation and Maintenance Disorders; Hypoventilation

Condition Hierarchy (Ancestors)

Sleep Disorders, Intrinsic; Dyssomnias; Sleep Wake Disorders; Nervous System Diseases; Mental Disorders; Respiratory Insufficiency; Respiration Disorders; Respiratory Tract Diseases; Signs and Symptoms, Respiratory; Signs and Symptoms; Pathological Conditions, Signs and Symptoms

Study Officials

• Qin Wei, Phd

  Xidian University

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: DOUBLE
• Who Masked: PARTICIPANT, OUTCOMES ASSESSOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: September 24, 2024
• First Posted: September 26, 2024
• Study Start: January 1, 2024
• Primary Completion: July 14, 2024
• Study Completion: July 31, 2024
• Last Updated: September 26, 2024

Record last verified: 2024-09

Locations

CN (1)