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

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.

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.

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.

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.

A brief screening tool for insomnia including seven items assessing the nature and symptoms of their sleep issues. Questions relate to the responder's sleep, symptom severity and satisfaction with their sleep, as well as the effect of their insomnia on daily function, social impact, and overall distress related to their sleep. Each question is answered on a 5-point Likert scale. Total scores range from 0-28, with a higher score indicating worse insomnia severity.

Standardized assessments by the healthcare team regarding level of assistance required by the participant for mobility, self-care, and cognition. The GG section assesses self-care (7 items) and mobility (17 items) on a scale from 1-6, with a higher number indicating greater independence. If a participant is unwilling or unsafe to perform an activity, or if the activity is not applicable or there is an environmental limitation, special codes can be applied.

The C section of the IRF-PAI assesses cognition via the Brief Interview for Mental Status comprising repetition of 3 words, temporal orientation, and recall. Participants are scored in this section from 1-15 with a higher score indicating better cognition. The presence of any acute-onset mental status change is considered here.