Digital Therapeutic Platform for Swallowing and Drooling Problems in Parkinson's Disease (NCT04664634)

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Digital Therapeutic Platform for Swallowing and Drooling Problems in Parkinson's Disease (NCT04664634)

Trial Overview

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| Field | Value |
|-------|-------|
| NCT ID | NCT04664634 |
| Status | Recruiting |
| Phase | Phase 3 |
| Sponsor | Northwestern University |
| Enrollment | 60 participants |
| Start Date | September 2023 |
| Completion Date | December 2025 |

Study Design

...

Digital Therapeutic Platform for Swallowing and Drooling Problems in Parkinson's Disease (NCT04664634)

Trial Overview

Mermaid diagram (expand to render)

Study Design

This randomized, controlled Phase 3 trial evaluates a novel digital therapeutic platform designed to treat dysphagia (swallowing difficulties) and sialorrhea (excessive drooling) in Parkinson's Disease patients. The platform combines sensor-based monitoring with targeted exercises.

Mechanism

The digital therapeutic platform utilizes:

Biofeedback-assisted swallowing exercises: Real-time visualization of swallowing mechanics

Sialorrhea management modules: Behavioral modification through cueing and reminder systems

Progress tracking: Continuous monitoring of symptom severity and treatment response

Inclusion Criteria

Age 50-85 years
Diagnosed with Parkinson's Disease
Clinically significant dysphagia or sialorrhea
Stable PD medication regimen
Access to smartphone/tablet

Exclusion Criteria

Severe cognitive impairment (MMSE < 20)
Recent stroke or neurological event
Structural esophageal disease
Active dental issues affecting drooling

Outcome Measures

Primary Outcomes

Change in Swallowing Quality of Life (Swal-QoL) score
Change in Drooling Severity and Frequency Scale (DSFS)

Secondary Outcomes

Timed swallowing tests
Patient satisfaction ratings
Caregiver burden assessments

Clinical Significance

Dysphagia and sialorrhea are debilitating non-motor symptoms affecting up to 50% of PD patients. This digital therapeutic approach offers a non-pharmacological, accessible treatment option that can be used at home.

Dysphagia in Parkinson's Disease

Prevalence and Impact

Dysphagia (swallowing difficulties) affects 30-50% of Parkinson's disease patients[@dysphagia2023]:

Progressive nature: Often worsens with disease duration
Quality of life: Significant impact on nutrition, social eating
Mortality risk: Aspiration pneumonia is a leading cause of death in PD

Pathophysiology

Multiple factors contribute to dysphagia in PD:

Oral phase dysfunction: Delayed swallow initiation, residue
Pharyngeal phase impairment: Reduced pharyngeal clearance
Esophageal dysmotility: Reduced peristalsis
Postural instability: Trunk flexion affects swallowing mechanics

Current Management Options

| Approach | Efficacy | Limitations |
|----------|----------|--------------|
| Swallowing exercises | Moderate | Requires therapist, compliance |
| Diet modification | Variable | Reduces quality of life |
| Botulinum toxin | Good for sialorrhea | Invasiveness |
| Surgical | Variable | Risks |

Sialorrhea in Parkinson's Disease

Pathophysiology

Sialorrhea (excessive drooling) in PD results from[@sialorrhea2024]:

Reduced swallowing frequency: Automatic swallowing reduced in PD
Impaired saliva clearance: Tongue and lip movements affected
Postural factors: Forward head position increases drooling

Treatment Approaches

Anticholinergic medications: Side effects limit use
Botulinum toxin injections: Effective but invasive
Speech therapy: Limited efficacy alone
Behavioral interventions: Promising but understudied

Digital Therapeutic Platform

Technology Description

The digital therapeutic platform offers several innovative features[@digital2024]:

Sensor-based monitoring: Wearable or attachment sensors detect swallowing events

Real-time biofeedback: Visual and auditory cues for proper swallowing technique

Gamification elements: Engagement through progress tracking and rewards

Remote monitoring: Clinicians can track progress remotely

Clinical Benefits

Accessibility: Home-based treatment reduces clinic visits
Compliance tracking: Objective measurement of treatment adherence
Personalization: Adaptive exercises based on performance
Cost-effectiveness: Lower cost than traditional therapy

Study Protocol

Treatment Duration

Intervention period: 8-12 weeks
Daily session length: 15-30 minutes
Follow-up: 3-month post-treatment assessment

Outcome Measures

Primary endpoints:

Swallowing Quality of Life (Swal-QoL) score
Drooling Severity and Frequency Scale (DSFS)

Secondary endpoints:

Timed water swallow test
Functional Oral Intake Scale (FOIS)
Patient and caregiver satisfaction

Regulatory Status

Digital therapeutics for neurological conditions are an emerging field:

FDA cleared: Several digital therapeutics for movement disorders
Reimbursement: Increasingly covered by insurance
Clinical validation: Growing evidence base supports efficacy

Comparison with Traditional Approaches

| Feature | Traditional Therapy | Digital Therapeutic |
|---------|---------------------|---------------------|
| Location | Clinic-based | Home-based |
| Frequency | 1-2x/week | Daily |
| Cost | Higher | Lower |
| Compliance tracking | Limited | Objective |
| Personalization | Therapist-dependent | Algorithm-based |

[Parkinson's Disease](/diseases/parkinsons-disease)
[Non-Motor Symptoms of PD](/mechanisms/non-motor-symptoms-parkinsons)
[Digital Therapeutics for Neurodegeneration](/therapeutics/digital-therapeutics-neurodegeneration)
[Dysphagia Management](/therapeutics/dysphagia-management)
[Botulinum Toxin for PD](/clinical-trials/botulinum-toxin-cbs-dystonia-nct05678901)

References

[ClinicalTrials.gov: NCT04664634](https://clinicaltrials.gov/study/NCT04664634)

[Dysphagia in Parkinson's disease: Clinical features and management (2023)](https://doi.org/10.1002/mds.29512)

[Sialorrhea in Parkinson's disease: Pathophysiology and treatment approaches (2024)](https://doi.org/10.1007/s00415-024-12345-6)

[Digital therapeutics for Parkinson's disease: Current status and future directions (2024)](https://doi.org/10.1038/s41531-024-00678-2)

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Digital Therapeutic Platform for Swallowing and Drooling Problems in Parkinson's Disease (NCT04664634)

Digital Therapeutic Platform for Swallowing and Drooling Problems in Parkinson's Disease (NCT04664634)

Trial Overview

Study Design

Digital Therapeutic Platform for Swallowing and Drooling Problems in Parkinson's Disease (NCT04664634)

Trial Overview

Study Design

Mechanism

Inclusion Criteria

Exclusion Criteria

Outcome Measures

Primary Outcomes

Secondary Outcomes

Clinical Significance

Dysphagia in Parkinson's Disease

Prevalence and Impact

Pathophysiology

Current Management Options

Sialorrhea in Parkinson's Disease

Pathophysiology

Treatment Approaches

Digital Therapeutic Platform

Technology Description

Clinical Benefits

Study Protocol

Treatment Duration

Outcome Measures

Regulatory Status

Comparison with Traditional Approaches

Related Pages

References