Neck Vibration Therapy for Chronic Cough

Overseen By Clinical Research Coordinators Ashley Ramaker, MS or colleagues

Age: 18+

Sex: Any

Trial Phase: Academic

Sponsor: University of Minnesota

Disqualifiers: Electronic implants, Speech therapy, others

No Placebo Group All trial participants will receive the active study treatment (no placebo)

Compensation: Varies

Number of Visits: Unknown

Duration: 3 weeks

60 Participants Needed

What You Need to Know Before You Apply

What is the purpose of this trial?

This trial aims to test whether gentle vibration therapy on the neck, known as Vibrotactile Stimulation (VTS), can reduce the severity of chronic cough without a known cause. The treatment uses a device to apply vibrations to the larynx (voice box) to determine if it eases symptoms. Individuals with a persistent cough lasting more than eight weeks and experiencing significant discomfort may be suitable candidates. However, those with electronic implants or certain health conditions, such as untreated reflux or unmanaged allergies, are not eligible. As an unphased trial, this study offers a unique opportunity to explore a novel therapy that could significantly improve quality of life.

Will I have to stop taking my current medications?

The trial information does not specify whether you need to stop taking your current medications.

What prior data suggests that this neck vibration therapy is safe for chronic cough?

Research has shown that using gentle vibrations, similar to neck vibration therapy, is generally safe. Studies have found it practical and acceptable for individuals with a long-term cough. Additionally, it has been linked to noticeable improvements in quality of life for those with coughs. No reports of serious side effects have emerged from these studies, suggesting that patients tolerate this treatment well. ^{1 2 3 4 5}

Why are researchers excited about this trial?

Most treatments for chronic cough, like cough suppressants and antihistamines, aim to reduce symptoms by acting on the nervous system or addressing underlying causes like allergies. However, vibrotactile stimulation is unique because it directly targets the neck area with gentle vibrations to potentially disrupt the cough reflex. Researchers are excited about this approach because it offers a non-invasive, drug-free alternative that could provide relief without the side effects associated with traditional medications. This method might offer a new way to manage chronic cough, especially for those who haven't found success with existing treatments.

What evidence suggests that vibrotactile stimulation is effective for chronic cough?

Research has shown that gently vibrating the throat area, known as vibrotactile stimulation (VTS), may help reduce symptoms of chronic cough. In this trial, participants will receive VTS as an experimental treatment. Studies have found this treatment practical and well-received by patients, leading to noticeable improvements in their quality of life related to coughing. This method calms the urge to cough, possibly by making the voice box less sensitive. While more research is needed, early results are promising for those with unexplained chronic cough. ^{1 2 3 5 6}

Who Is on the Research Team?

Stephanie Misono

Principal Investigator

University of Minnesota

Are You a Good Fit for This Trial?

This trial is for English-speaking adults aged 18-88 who have been coughing for more than 8 weeks and rate their cough severity at 30 or higher on a scale of 0 to 100. Participants must be able to give informed consent and fill out questionnaires by themselves. People with electronic implants, no wifi access, contraindications to the device used in the study, or those currently in speech therapy for cough cannot join.

Inclusion Criteria

I have been coughing for more than 8 weeks.

Ability to provide informed consent and independently complete questionnaires

My cough severity is rated 30 or higher on a scale of 0-100.

Exclusion Criteria

Electronic implants (e.g., pacemaker)

No regular access to wifi internet

You are unable to use the VTS device safely and effectively.

Timeline for a Trial Participant

Screening

Participants are screened for eligibility to participate in the trial

2-4 weeks

Treatment

Participants receive non-invasive vibrotactile stimulation of the larynx to assess its effect on unexplained chronic cough

3 weeks

Follow-up

Participants are monitored for safety and effectiveness after treatment

4 weeks

What Are the Treatments Tested in This Trial?

Interventions

• Vibrotactile Stimulation

Trial Overview The study is examining how non-invasive vibrotactile stimulation (VTS) of the larynx affects people with unexplained chronic cough. Researchers want to see if this treatment can reduce the severity of symptoms.

How Is the Trial Designed?

Group I: Vibrotactile Stimulation Experimental Treatment 1 Intervention

Who Is Running the Clinical Trial?

University of Minnesota

Lead Sponsor

Trials

1,459

Recruited

1,623,000+

Published Research Related to This Trial

In a study involving high-frequency (100Hz) transcutaneous electrical nerve stimulation (TENS) applied for 13 minutes, TENS at a proximal site significantly increased vibrotactile thresholds for both 20Hz and 150Hz stimuli.

The elevation in vibrotactile thresholds is likely caused by peripheral electrogenic blockade, indicating that TENS can interfere with the normal function of vibration receptors.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Vibrotactile threshold elevation produced by high-frequency transcutaneous electrical nerve stimulation. Pertovaara, A., Hämäläinen, H.[2004]

A study involving 10 male subjects found that simultaneous exposure to whole-body vibration (WBV) and hand-arm vibration (HAV) significantly increased the vibrotactile perception threshold (VPT), indicating a greater impact on sensory perception compared to exposure to either type of vibration alone.

The results suggest that combined vibration exposure can lead to more pronounced changes in sensory perception, which could have implications for understanding the effects of vibration in occupational settings.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Research on simultaneous impact of hand-arm and whole-body vibration. Kowalski, P., Zając, J.[2012]

Vibrotactile stimulation (VS) on the forearm was found to elicit higher subjective responses from participants when applied to the lateral side compared to the medial side, across all groups studied (young adults, elderly, and amputees).

Some participants reported feelings of displeasure in response to VS, indicating that emotional responses to vibration can vary by factors such as age, sex, and amputation status.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Evaluation of physical and emotional responses to vibrotactile stimulation of the forearm in young adults, the elderly, and transradial amputees. Ko, CY., Chang, Y., Kim, SB., et al.[2014]

The study found that the temporary threshold shift of vibratory sensation (TTS(v)) in the fingertip increases significantly with longer exposure to hand-arm vibration, indicating a clear relationship between exposure duration and sensory threshold changes.

The recovery of TTS(v) after vibration exposure follows an exponential pattern, suggesting that the time taken to return to baseline sensitivity may require improved measurement methods for more accurate assessment.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Dependency of temporary threshold shift of vibratory sensation in fingertip on 1/3 octave-band hand-arm vibration exposure period. Nishiyama, K., Taoda, K.[2021]

In a pilot study with 8 participants suffering from unilateral vestibular disorders, those who received vibrotactile sensory augmentation during balance training showed significantly greater improvements in balance confidence and postural stability compared to those who did not receive this sensory aid.

The benefits of incorporating vibrotactile sensory augmentation were observed to last up to six months after the training, suggesting it may enhance vestibular rehabilitation outcomes.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Effects of long-term vestibular rehabilitation therapy with vibrotactile sensory augmentation for people with unilateral vestibular disorders - A randomized preliminary study. Bao, T., Klatt, BN., Carender, WJ., et al.[2022]

High frequency vibration (110 Hz) significantly increases the muscular pain threshold in healthy individuals when applied to the skin overlying the quadriceps tendon, indicating a potential method for pain modulation.

This pain threshold elevation is likely due to the activation of rapidly adapting receptors and pacinian corpuscles, which may inhibit pain signals at the spinal level, while low frequency vibration (30 Hz) does not have a consistent effect.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Effects of vibratory stimulation on muscular pain threshold and blink response in human subjects. Pantaleo, T., Duranti, R., Bellini, F.[2021]

A new oral motor exercise apparatus that uses bony vibration at 89 Hz effectively stimulates salivation in various salivary glands, indicating its potential for enhancing orofacial rehabilitation.

The device is designed for extended use and is safe, utilizing protective materials to ensure comfort during vibration therapy, making it a promising tool for patients with masticatory disturbances and dysphagia.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Increased secretion of salivary glands produced by facial vibrotactile stimulation. Hiraba, H., Yamaoka, M., Fukano, M., et al.[2022]

In a study involving 20 severely disabled patients, vibration therapy (VT) significantly reduced state anxiety levels and cortisol, a stress hormone, indicating its potential as an anti-stress intervention.

Despite no changes in socio-psychological variables, the results suggest that short exposure to low-frequency vibration is a safe and effective method to improve hormone responses in this population.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Effects of vibration therapy on hormone response and stress in severely disabled patients: a double-blind randomized placebo-controlled clinical trial. Seco, J., Rodríguez-Pérez, V., López-Rodríguez, AF., et al.[2015]

Vibroacoustic therapy (VAT) has been explored in 20 studies focusing on pain management, primarily for chronic pain, but the research is limited and lacks consistency in protocols, making it difficult to draw definitive conclusions about its efficacy.

Most studies used a frequency of 40 Hz for VAT sessions lasting between 20 to 45 minutes, with more frequent treatments for acute pain compared to chronic pain, highlighting the need for standardized measurements and randomized controlled trials to better understand VAT's effectiveness.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Exploring vibroacoustic therapy in adults experiencing pain: a scoping review. Kantor, J., Campbell, EA., Kantorová, L., et al.[2022]

In a study involving 20 patients with left-sided neglect, combining neck muscle vibration with visual exploration training led to significant and lasting improvements in neglect symptoms, particularly in visual perception and daily activities, observed two months post-treatment.

In contrast, visual exploration training alone provided only minor benefits, highlighting the importance of neck muscle vibration as an effective rehabilitation technique for spatial neglect.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Neck muscle vibration induces lasting recovery in spatial neglect. Schindler, I., Kerkhoff, G., Karnath, HO., et al.[2022]

Vibrotactile positional therapy (PT) significantly reduced the Apnoea Hypopnoea Index (AHI) by an average of 9.19 events/hour and decreased the percentage of time spent in the supine position (%Tsupine) by 32.79% in patients with positional obstructive sleep apnoea (POSA), based on a systematic review of 18 studies involving 1119 initial studies.

While vibrotactile PT was effective in reducing AHI and %Tsupine, its impact on secondary outcomes like daytime sleepiness and quality of life was minimal, indicating a need for further research to explore these aspects more thoroughly.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Efficacy of vibrotactile positional therapy devices on patients with positional obstructive sleep apnoea: a systematic review and meta-analysis. ALQarni, AS., Turnbull, CD., Morrell, MJ., et al.[2023]

This pilot study investigates how two different vibrotactile feedback devices can help elderly individuals with body orientation and sensory information during walking tasks.

The results suggest that sensory substitution devices using vibrotactile feedback may improve locomotion in older adults, highlighting their potential as assistive technologies for enhancing mobility and safety.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Vibrotactile feedback of mediolateral trunk tilt or foot pressure increases locomotor performance in healthy older adults--a pilot study. Wall, C., Wrisley, D., Oddsson, L.[2020]

Citations

1. onlinelibrary.wiley.com onlinelibrary.wiley.com/doi/full/10.1002/lary.31673

Laryngeal Vibrotactile Stimulation Is Feasible, Acceptable ... Laryngeal VTS was feasible and acceptable for use by patients with chronic cough and was associated with a meaningful improvement in cough-related quality of ...

2. clinicaltrials.gov clinicaltrials.gov/study/NCT05273190

Study Details | NCT05273190 | Stimulation of the Larynx to ... Most clinical studies have one primary outcome measure, but some have more than one. ... The main reason for the clinical trial. The types of primary purpose are: ...

3. pubmed.ncbi.nlm.nih.gov pubmed.ncbi.nlm.nih.gov/39092681

Laryngeal Vibrotactile Stimulation Is Feasible, Acceptable To ... Ongoing cough can sensitize the larynx, increasing the urge to cough and perpetuating the cycle of chronic cough. Vibrotactile stimulation (VTS) of the larynx ...

4. withpower.com withpower.com/trial/phase-cough-6-2021-95569

Neck Vibration Therapy for Chronic Cough What data supports the effectiveness of the treatment Vibrotactile Stimulation (VTS) for chronic cough? Research on similar treatments, like neck muscle ...

5. sciencedirect.com sciencedirect.com/science/article/abs/pii/S0892199722003691

Standardized Behavioral Treatment Improves Chronic Cough There was a clinically significant change in 66% of all patients, 76% of which presented with abnormal NLHQ scores, and 14% who presented with normal NLHQ ...

6. ctv.veeva.com ctv.veeva.com/study/stimulation-of-the-larynx-to-treat-unexplained-chronic-cough

Stimulation of the Larynx to Treat Unexplained Chronic Cough Researchers will test the effect of non-invasive vibrotactile stimulation of the larynx on symptom severity of unexplained chronic cough.