InsomniaNCT07730762
A Study of Transcutaneous Auricular Vagus Nerve Stimulation (taVNS) for Insomnia During Pregnancy
A study testing transcutaneous auricular vagus nerve stimulation in people with Insomnia, run by Xijing Hospital at 1 site in China.
Trial summary
The goal of this clinical trial is to learn whether transcutaneous auricular vagus nerve stimulation (taVNS) can treat insomnia during pregnancy. It will also learn about the safety of taVNS for pregnant women and their fetuses. Read more about this study
- Who is it for?
- Ages 18 to 35 years, women only
- Conditions the study is for
- Insomnia
- What is being tested?
- transcutaneous auricular vagus nerve stimulation
- Type of treatment
- Medical device
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 200 participants
- Where
- 1 siteChina
- Study dates
- 30 Aug 2024to 31 Dec 2026
- Phase
- Interventional
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 35 years
- Women only
- No healthy volunteers
- Adult
Who may be able to join
- Females aged 18-35 years, gestational age 20-34 weeks. Stable physical condition confirmed by routine laboratory tests (complete blood count, liver function, renal function, thyroid-stimulating hormone), urine toxicology screening, and electrocardiogram (ECG) at screening.
- Fetal ultrasound and fetal heart rate monitoring performed and assessed by an obstetrician-gynecologist prior to enrollment.
- Insomnia symptoms meeting all of the following criteria:
- At least one of: (a) sleep onset latency > 30 minutes; (b) nocturnal awakenings ≥ 2 times/night; (c) total sleep time < 6 hours; (d) accompanied by daytime dysfunction.
- Symptoms occur despite adequate opportunity and appropriate circumstances for sleep.
- At least one sleep-related daytime impairment: fatigue/malaise; impaired attention/memory; decreased academic/occupational/social functioning; mood disturbances/irritability; daytime sleepiness; reduced interest/energy; increased errors during work or driving; tension/headache/dizziness or other somatic symptoms related to sleep deficiency.
- Symptoms persisted for ≥ 2 weeks. Confirmed eligible for enrollment by both an obstetrician and a neurologist. Willing and able to provide signed informed consent.
Who cannot join
- History of psychiatric disorders prior to pregnancy. History of psychoactive substance abuse. Prior exposure to taVNS (transcutaneous auricular vagus nerve stimulation) treatment.
- Cardiac arrhythmia, particularly bradycardia. Currently receiving hypnotic medications or other insomnia treatments. Known fetal abnormalities (e.g., intrauterine growth restriction, congenital malformations, or cardiac rhythm abnormalities detected on fetal ultrasound).
- History of adverse pregnancy outcomes or current pregnancy with known obstetric complications (e.g., gestational hypertension, gestational diabetes, or abnormal prenatal examination results).
- Deemed unsuitable for enrollment following assessment by either the obstetrician or neurologist.
Trial locations and contacts
1 site in 1 country.
About this study
The goal of this clinical trial is to learn whether transcutaneous auricular vagus nerve stimulation (taVNS) can treat insomnia during pregnancy. It will also learn about the safety of taVNS for pregnant women and their fetuses. The main questions it aims to answer include:
Can taVNS improve sleep quality in patients with gestational insomnia, as measured primarily by the Insomnia Severity Index (ISI)? Compared with a 2-week delayed intervention, can starting taVNS intervention 2 weeks earlier lead to superior improvements in sleep and mood outcomes? Does taVNS have any adverse effects on maternal electrocardiogram, fetal ultrasound, or fetal heart rate? What medical problems (adverse events) do participants experience when receiving taVNS treatment? Researchers will compare active taVNS with sham stimulation (the device looks and operates the same but delivers no effective current), while also incorporating a delayed-intervention group (no intervention during the first 2 weeks) as a temporal control, to observe whether taVNS can treat gestational insomnia and whether earlier intervention offers additional advantages.
Read more
Participants will:
Receive active taVNS or sham stimulation according to their randomized group assignment during specified time periods, at a frequency of 2-3 times daily, 30 minutes per session, for 14 consecutive days (the early-intervention group begins immediately upon enrollment; the late-intervention group has a 2-week waiting period after enrollment before starting intervention; the early-intervention group undergoes crossover at Day 15).
Complete a 3-day pre-trial period after enrollment for device operation training and individualized stimulation intensity setting.
Attend hospital follow-up visits at baseline (Day 0), Day 15, and Day 30 to complete sleep assessments (ISI, AIS, PSQI, ESS) and mood assessments (HAMA, HAMD).
Undergo repeated maternal electrocardiogram, fetal ultrasound, and fetal heart rate monitoring before and after treatment to evaluate safety.
Maintain a daily treatment diary (recording usage time, frequency, and any adverse symptoms), with device-internal usage logs cross-checked against diaries to ensure adherence.
- Conditions
- Insomnia
- Being tested
- transcutaneous auricular vagus nerve stimulation, sham taVNS stimulation
- Keywords
- Pregnant participants, Insomnia, transcutaneous auricular vagus nerve stimulation
- Medical subject headings
- Sleep Initiation and Maintenance Disorders
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
transcutaneous auricular vagus nerve stimulationDevice
The taVNS parameters were set at a pulse width of 200 μs and a frequency of 30 Hz.
sham taVNS stimulationDevice
The taVNS parameters were set at a pulse width of 200 μs and a frequency of 10 Hz.
| Study group | Role | What they receive |
|---|---|---|
| Early intervention group: active taVNS first, then sham stimulation (crossover at Day 15) | Experimental | Not described Receives: Device: transcutaneous auricular vagus nerve stimulation |
| Early intervention group: sham stimulation first, then active taVNS (crossover at Day 15) | Experimental | Not described Receives: Device: transcutaneous auricular vagus nerve stimulation |
| Late intervention group: 2-week waiting period first, followed by 2 weeks of active taVNS | Experimental | Not described Receives: Device: transcutaneous auricular vagus nerve stimulation |
| Late intervention group: 2-week waiting period first, followed by 2 weeks of sham taVNS | Sham comparator | Not described Receives: Device: sham taVNS stimulation |
What is being measured
The primary outcome is the main question the study is designed to answer.
Insomnia Severity Index (ISI)
Measured: Change from baseline in Insomnia Severity Index (ISI) at week 2 and week 4
Epworth Sleepiness Scale (ESS)
Measured: Change from baseline in Epworth Sleepiness Scale (ESS)at week 2 and week 4.
Pittsburgh Sleep Quality Index (PSQI)
Measured: Change from baseline in Pittsburgh Sleep Quality Index (PSQI) at week 2 and week 4.
Secondary outcomes (2)
Hamilton Anxiety Rating Scale (HAMA)
Measured: Change from baseline in Hamilton Anxiety Rating Scale (HAMA) at week 2 and week 4.
Hamilton Depression Rating Scale (HAMD)
Measured: Change from baseline in Hamilton Depression Rating Scale (HAMD) at week 2 and week 4.
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted28 Jul 2026
- Study start30 Aug 2024
- Primary completion30 Nov 2026 (estimated)
- Study completion31 Dec 2026 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for InsomniaStudies of the same condition, open and under way.
- More trials run by Xijing HospitalThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Crossover
- Masking
- Quadruple blind
- Who is masked
- Participant, Care provider, Investigator, Outcomes assessor
- Enrolment
- 200 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Xijing Hospital
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07730762
- Sponsor's protocol ID
- KY20242114-F-1
- Status last verified
- Jul 2026
- First submitted
- 23 Jul 2026
- Last updated
- 28 Jul 2026
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Yes: all collected IPD
Study at a glance
From the registry record, last updated by the sponsor on 28 Jul 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Study of Transcutaneous Auricular Vagus Nerve Stimulation (taVNS) for Insomnia During Pregnancy
- ClinicalTrials.gov ID
- NCT07730762
- Acronym / sponsor ID
- KY20242114-F-1
- Conditions
- Insomnia
- Keywords
- Pregnant participants, Insomnia, transcutaneous auricular vagus nerve stimulation
- Study type
- Interventional
- Recruitment status
- Active, not recruiting
- Enrolment
- 200 participants (estimated)
- Lead sponsor
- Xijing HospitalUniversity, hospital or other
- Study start
- 30 Aug 2024 (actual)
- Primary completion
- 30 Nov 2026 (estimated)
- Study completion
- 31 Dec 2026 (estimated)
- First posted
- 28 Jul 2026 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
The goal of this clinical trial is to learn whether transcutaneous auricular vagus nerve stimulation (taVNS) can treat insomnia during pregnancy. It will also learn about the safety of taVNS for pregnant women and their fetuses. The main questions it aims to answer include:
Can taVNS improve sleep quality in patients with gestational insomnia, as measured primarily by the Insomnia Severity Index (ISI)? Compared with a 2-week delayed intervention, can starting taVNS intervention 2 weeks earlier lead to superior improvements in sleep and mood outcomes? Does taVNS have any adverse effects on maternal electrocardiogram, fetal ultrasound, or fetal heart rate? What medical problems (adverse events) do participants experience when receiving taVNS treatment? Researchers will compare active taVNS with sham stimulation (the device looks and operates the same but delivers no effective current), while also incorporating a delayed-intervention group (no intervention during the first 2 weeks) as a temporal control, to observe whether taVNS can treat gestational insomnia and whether earlier intervention offers additional advantages.
Participants will:
Receive active taVNS or sham stimulation according to their randomized group assignment during specified time periods, at a frequency of 2-3 times daily, 30 minutes per session, for 14 consecutive days (the early-intervention group begins immediately upon enrollment; the late-intervention group has a 2-week waiting period after enrollment before starting intervention; the early-intervention group undergoes crossover at Day 15).
Complete a 3-day pre-trial period after enrollment for device operation training and individualized stimulation intensity setting.
Attend hospital follow-up visits at baseline (Day 0), Day 15, and Day 30 to complete sleep assessments (ISI, AIS, PSQI, ESS) and mood assessments (HAMA, HAMD).
Undergo repeated maternal electrocardiogram, fetal ultrasound, and fetal heart rate monitoring before and after treatment to evaluate safety.
Maintain a daily treatment diary (recording usage time, frequency, and any adverse symptoms), with device-internal usage logs cross-checked against diaries to ensure adherence.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Crossover
- Masking
- Quadruple blind (participant, care provider, investigator, outcomes assessor)
- Number of arms
- 4
| Arm | Type | Receives |
|---|---|---|
| Early intervention group: active taVNS first, then sham stimulation (crossover at Day 15) | Experimental | Device: transcutaneous auricular vagus nerve stimulation |
| Early intervention group: sham stimulation first, then active taVNS (crossover at Day 15) | Experimental | Device: transcutaneous auricular vagus nerve stimulation |
| Late intervention group: 2-week waiting period first, followed by 2 weeks of active taVNS | Experimental | Device: transcutaneous auricular vagus nerve stimulation |
| Late intervention group: 2-week waiting period first, followed by 2 weeks of sham taVNS | Sham comparator | Device: sham taVNS stimulation |
Who may qualify
- Ages
- 18 to 35 years
- Sex
- Female only
- Healthy volunteers
- Not accepted
- Age groups
- Adult
Key inclusion criteria (7 listed)
- Females aged 18-35 years, gestational age 20-34 weeks. Stable physical condition confirmed by routine laboratory tests (complete blood count, liver function, renal function, thyroid-stimulating hormone), urine toxicology screening, and electrocardiogram (ECG) at screening.
- Fetal ultrasound and fetal heart rate monitoring performed and assessed by an obstetrician-gynecologist prior to enrollment.
- At least one of: (a) sleep onset latency > 30 minutes; (b) nocturnal awakenings ≥ 2 times/night; (c) total sleep time < 6 hours; (d) accompanied by daytime dysfunction.
- Symptoms occur despite adequate opportunity and appropriate circumstances for sleep.
- At least one sleep-related daytime impairment: fatigue/malaise; impaired attention/memory; decreased academic/occupational/social functioning; mood disturbances/irritability; daytime sleepiness; reduced interest/energy; increased errors during work or driving; tension/headache/dizziness or other somatic symptoms related to sleep deficiency.
Key exclusion criteria (4 listed)
- History of psychiatric disorders prior to pregnancy. History of psychoactive substance abuse. Prior exposure to taVNS (transcutaneous auricular vagus nerve stimulation) treatment.
- Cardiac arrhythmia, particularly bradycardia. Currently receiving hypnotic medications or other insomnia treatments. Known fetal abnormalities (e.g., intrauterine growth restriction, congenital malformations, or cardiac rhythm abnormalities detected on fetal ultrasound).
- History of adverse pregnancy outcomes or current pregnancy with known obstetric complications (e.g., gestational hypertension, gestational diabetes, or abnormal prenatal examination results).
- Deemed unsuitable for enrollment following assessment by either the obstetrician or neurologist.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| transcutaneous auricular vagus nerve stimulationThe taVNS parameters were set at a pulse width of 200 μs and a frequency of 30 Hz. | Device | Early intervention group: active taVNS first, then sham stimulation (crossover at Day 15), Early intervention group: sham stimulation first, then active taVNS (crossover at Day 15), Late intervention group: 2-week waiting period first, followed by 2 weeks of active taVNS |
| sham taVNS stimulationThe taVNS parameters were set at a pulse width of 200 μs and a frequency of 10 Hz. | Device | Late intervention group: 2-week waiting period first, followed by 2 weeks of sham taVNS |
Primary outcome
Insomnia Severity Index (ISI)
Time frame: Change from baseline in Insomnia Severity Index (ISI) at week 2 and week 4
Epworth Sleepiness Scale (ESS)
Time frame: Change from baseline in Epworth Sleepiness Scale (ESS)at week 2 and week 4.
Pittsburgh Sleep Quality Index (PSQI)
Time frame: Change from baseline in Pittsburgh Sleep Quality Index (PSQI) at week 2 and week 4.
2 secondary outcomes
Hamilton Anxiety Rating Scale (HAMA)
Time frame: Change from baseline in Hamilton Anxiety Rating Scale (HAMA) at week 2 and week 4.
Hamilton Depression Rating Scale (HAMD)
Time frame: Change from baseline in Hamilton Depression Rating Scale (HAMD) at week 2 and week 4.
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 28 Jul 2026.
- Individual participant dataSharing planned: Yes. all collected IPD
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
The record lists no contact. Use the official record to reach the sponsor.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing transcutaneous auricular vagus nerve stimulation in people with Insomnia, run by Xijing Hospital at 1 site in China.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 7 inclusion and 4 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: under way, not looking for participants, as of the sponsor's last update on 28 Jul 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in China. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. Some participants in this study may receive a placebo. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Insomnia Severity Index (ISI) (time frame: Change from baseline in Insomnia Severity Index (ISI) at week 2 and week 4). The study lists 3 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 28 Jul 2026.