Vagus Nerve Stimulation on Improving Sleep in Inpatient Rehab for Post-Acute Stroke

Conditions

• Ischemic Cerebrovascular Accident
• Ischemic Stroke
• Stroke
• Vagal Nerve Stimulation

Eligibility Criteria

Sex

ALL

Age

18 Years - N/A

Healthy Volunteers

Not accepted

Interventions

• transauricular Vagal Nerve Stimulation — DEVICE
  All participants will be instructed around the use of the non-invasive taVNS Parasym device (by Parasym Ltd., London). Participants will be instructed to utilize the Parasym device for 30min daily between 7-9pm for at least 10 days following. Stimulation parameters will be set at 200µs pulse width (with proprietary waveform) and 20Hz. The intensity will be set to level 21 and increased up to 32 as tolerated, but reduced sequentially to intensity level 12 if unable to tolerate due to discomfort. They will include amplitudes 1.0-1.7mA for therapeutic thresholds.
• Sham Comparator — DEVICE
  All participants will be instructed around the use of the non-invasive taVNS Parasym device (by Parasym Ltd., London). Participants will be instructed to utilize the Parasym device for 30min daily between 7-9pm for at least 10 days following. Stimulation parameters will be set to the same parameters as for the experimental group, however his device will include a sham earpiece that will prevent the transmission of taVNS.

Study Details

The goal of this clinical trial is to learn if a device which provides vagal nerve stimulation, applied to the tragus of the ear via an ear clip, can improve sleep in individuals recovering from stroke while they are treated in a rehabilitation hospital. The main questions this study aims to answer are: 1. Does using this device improve insomnia? 2. Does this device have any impact on the person's stroke severity, mobility, self-care, or ability to think? Researchers will compare this treatment to a sham (a look-alike device that will not deliver the stimulation). Participants will: * Complete questionnaires about insomnia and their ability to think * Use the device for 30 minutes every evening for at least 10 nights during their inpatient stay * Complete a log tracking their use of the device and any concerns

Key Dates

First listed

Oct 5, 2026

Start date

Oct 16, 2026

Status verified

Oct 2026

Primary completion

Oct 16, 2027

Completion

Dec 16, 2027

Study Design

Enrollment

52 participants (estimated)

Allocation

RANDOMIZED

Intervention model

PARALLEL

Primary purpose

TREATMENT

Arms

• Experimental: transauricular Vagal Nerve Stimulation (taVNS)
  Participants will be assessed for cognition via the Mini Mental Exam and the Insomnia Severity Index (ISI). The initial assessments will be completed within the first 3-5 days from admission to the acute rehabilitation unit. Participants will receive a handout on sleep hygiene. Participants will be instructed around the use of the non-invasive taVNS Parasym device (by Parasym Ltd., London) and the training log which will include reporting of any side effects and any other personal bedtime routines to assist with sleep. The participant will be instructed to utilize the Parasym device for 30min daily between 7-9pm for at least 10 days following. Reassessment of the ISI will be completed at 12-15 days, or earlier if the patient discharges prior to this timeline. These participants will continue to receive the usual care for their individual rehabilitation program including therapy and medication interventions.
• Sham Comparator: Sham transauricular Vagal Nerve Stimulation (Sham taVNS)
  Participants will be assessed for cognition via the Mini Mental Exam and the Insomnia Severity Index (ISI). The initial assessments will be completed within the first 3-5 days from admission to the acute rehabilitation unit. Participants will receive a handout on sleep hygiene. Participants will be instructed around the use of the non-invasive taVNS Parasym device (by Parasym Ltd., London) and the training log which will include reporting of any side effects and any other personal bedtime routines to assist with sleep. The participant will be instructed to utilize the Parasym device for 30min daily between 7-9pm for at least 10 days following. For this group, their issued devices will include a sham earpiece that will prevent transmission of taVNS. The ISI will be re-assessed at 12-15 days, or earlier if the patient discharges prior to this timeline. Participants will continue to receive the usual care for their individual rehabilitation program, including therapy and medications.

Primary Outcome Measure

Insomnia Severity Index [ Time Frame: Initial assessment on Day 3-5 of their inpatient stay. Reassessment at 12-15 days, or earlier if the patient discharges prior to this timeline. ]

Central Contacts

• Marie Yeseta, PT, DPT, NCS
  9095967733
  [email protected]
• Hannah Cone, PT, DPT, NCS
  9095967733
  [email protected]

Locations (1)

Find similar trials in Pomona, CA

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