Use of the Passy Muir Swallowing Self Trainer
Condition: Stroke; Brain Injury; Head and Neck Cancer
MeSH terms: Brain Injuries
Study type: Observational

Summary: 
      The purpose of this study is to develop appropriate training methods and gather participant
      feedback on their use of the Passy Muir Swallowing Self-Training Device (PMSST). The PMSST is
      a small device that provides external vibratory stimulation to the larynx during swallowing
      and swallowing training. A secondary purpose of the study is to determine how 3 months of use
      of the PMSST affects swallowing physiology, brain activation, oral intake and quality of
      life. This was an uncontrolled pilot study aimed at gaining patient feedback on use of the
      vibratory device.
    

Detailed description: 
      The investigators are currently developing the Passy Muir Swallowing Self-Trainer to continue
      treatment of dysphagia after the patient is discharged to home. The self-training device is
      worn around the neck with motors placed externally on the skin over the thyroid cartilage to
      provide vibratory stimulation to the larynx. The vibrations activate the sensory receptors
      inside the larynx which excite central nervous system (CNS) control for swallowing and can
      help the patient to initiate swallowing. Patients can use the self-training device at home to
      promote swallowing rehabilitation during daily swallowing practice. The device can also be
      programmed to vibrate at regular intervals throughout the day to promote saliva swallows.
      Using this method, the patient can continue their swallowing therapy independently and in a
      manner that is cost effective. A previous Phase I trial compared the clinical outcomes of 8
      patients with chronic dysphagia using either an intramuscular electrical stimulation implant
      device or an external vibratory stimulator to practice swallowing daily at home. Functional
      outcomes of oral intake improved with both devices. As the external vibratory stimulation has
      the advantage of being external and completely noninvasive, it has been selected for further
      development as a self-training device. A second pilot study examined the effect of different
      frequencies of vibration on the swallowing frequency of healthy participants and found
      swallowing rate significantly increased from baseline when using a vibration of either 70 Hz
      or 150 Hz (Mulheren and Ludlow, 2017). Data has also been collected on the effect of
      different vibration characteristics on swallowing in participants who have swallowing
      problems after stroke (Kamarunas et al., in press).

      Purpose: The purpose of this study is to allow patients with chronic dysphagia to use the
      Self-Trainer for daily swallowing practice in their home and collect feedback on device use
      and satisfaction and use. Objective information on the effectiveness of self-training for
      swallowing rehabilitation will also be gathered.

      Objectives:

        1. To develop and evaluate training for participants and caregivers to use the
           self-trainer.

        2. To gather participant feedback on the use of the device after 3 months of daily
           practice.

        3. To determine how 3 months of daily practice with the Passy Muir Swallowing Self-Trainer
           affects swallowing physiology, brain activation, oral intake, and quality of life in
           participants with chronic dysphagia.
    

Intervention name(s): Dysphagia retraining with device
Intervention type(s): Device
Intervention description(s): Patients used the device for 60 trials of retraining swallowing at home each day and also had the device turned on throughout the day in automatic mode to intermittently trigger every few minutes to trigger a swallow for saliva control
Other intervention name(s): Passy Muir Swallowing Self Trainer
Observational model: Cohort
Time perspective: Prospective
Sampling method: Non-Probability Sample
Study population: 
        Chronic severe dysphagia requiring Percutaneous Endoscopic Gastrostomy (PEG) tube for
        nutrition