Skip to content

Using electrical stimulation of the ear to change cough reflex sensitivity

Identifying optimal auricular stimulation parameters for modulating cough sensitivity in healthy human adults

Status
Completed
Phases
Unknown
Study type
Interventional
Source
ANZCTR
Registry ID
ACTRN12623000128695
Enrollment
16
Registered
2023-02-07
Start date
2022-03-01
Completion date
2022-08-30
Last updated
2024-09-16

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

Conditions

None listed

Brief summary

Neurological disease, such as stroke, has a devastating effect on sensation in the throat and the cough reflex. Without the ability to detect food or fluid from entering the lungs and eject it with a cough, stroke patients are at a high risk of developing chest infection. Chest infection is associated with prolonged hospitalisation, high death rate, and significant cost to the healthcare system. There are currently limited rehabilitation options available. Interestingly, probing the ear canal during a medical examination or having impacted ear wax can cause coughing. We propose to develop a protocol and explore the effect of using light electrical stimulation of the nerves within the outer ear (transcutaeneous auricular vagus nerve stimulation; taVNS) to improve cough sensitivity after stroke. Using a wearable device to stimulate the external ear has the potential of providing a portable, safe, non-invasive, and low-cost treatment for improving the cough reflex and boosting airway protection. The aim of this study is to find the optimal location and frequency of ear stimulation for improving cough reflex sensitivity in healthy participants. The effects of different stimulation frequencies (high vs. low), stimulation zone (ear canal vs. concha), and side of stimulation (right vs. left ear) on cough sensitivity will be investigated. The parameters in this study that result in the greatest decrease in citric acid cough threshold (i.e., greatest increase in cough sensitivity) will be used as the stimuluation parameters in a future randomised controlled trial investigating taVNS as a treatment for cough sensitivity in individuals with neurological disorders.

Interventions

Non-invasive auricular stimulation was delivered to the seated participant for 10 minutes of continuous stimulation using a CE-approved home-use transcutaneous electrical nerve stimulation device. Single-use flexible hydrogel electrodes (RELI-Stick, Soterix Medical, New York, NY, USA) were placed on the concha and external auditory canal of the ear, with electrode gel applied on the electrodes. Stimulation intensity was adjusted at the beginning of each stimulation block as above the participant

Non-invasive auricular stimulation was delivered to the seated participant for 10 minutes of continuous stimulation using a CE-approved home-use transcutaneous electrical nerve stimulation device. Single-use flexible hydrogel electrodes (RELI-Stick, Soterix Medical, New York, NY, USA) were placed on the concha and external auditory canal of the ear, with electrode gel applied on the electrodes. Stimulation intensity was adjusted at the beginning of each stimulation block as above the participant’s detection threshold and below their pain threshold. Delivery of intervention was performed by a research speech-language therapist, face-to-face and individually with each participant. Each participant had 8 sessions of intervention, spaced at least 2 days apart, at a research laboratory. Stimulation parameters varied by stimulation side (right ear, left ear), stimulation zone (ear canal, concha), and stimulation frequency (25 Hz, 80 Hz), for a total of eight conditions. Each participant received 1 condition per visit, for a total of eight 1-hour visits. Order of visits were incompletely counterbalanced between participants. Two balanced Latin squares were used to generate 16 different visit sequences (https://cs.uwaterloo.ca/~dmasson/tools/latin_square/) and participants were randomly assigned to a sequence.

Sponsors

Yusuf Ozgur Cakmak
Lead SponsorIndividual

Study design

Allocation
Randomised controlled trial
Intervention model
Crossover
Primary purpose
Treatment
Masking
Blinded (masking used) (Subject)

Eligibility

Sex/Gender
All
Age
18 Years to No maximum
Healthy volunteers
Yes

Inclusion criteria

Healthy adult humans

Exclusion criteria

- History of swallowing, psychiatric, neurological, gastro-esophageal reflux, or cardio-respiratory disorders (e.g., chronic obstructive pulmonary disease or asthma); - History of recent (< 2 weeks) acute upper respiratory tract infection; - Current or previous smoker; - Currently taking opioid or angiotensin-converting enzyme (ACE) inhibiting drugs; - Currently pregnant; - Presence of an implanted device (e.g., pacemaker).

Outcome results

None listed

Source: ANZCTR · Data processed: Feb 7, 2026