AzTrials
AzTrials

Oropharyngeal Dysphagia (OPD)NCT07618637

Results of Combined Medical and Swallowing Behavioral Readjustment Therapy in Oropharyngeal Dysphagia Management Among Parkinson's Patients

A study testing combined pharmaceutical treatment and rehabilitation techniques and pharmaceutical treatment only in people with Oropharyngeal Dysphagia (OPD) and Parkinson, run by Tanta University at 1 site in Egypt.

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Official record
Search all trials

Trial summary

The study aims to assess the efficacy of using swallowing behavioral readjustment technique in combination with medical treatment in management of oropharyngeal dysphagia among Parkinson's patients in order to improve the management protocol Read more about this study

Who is it for?
Ages 30 years and olderHealthy volunteers can take part
What is being tested?
combined pharmaceutical treatment and rehabilitation techniques and pharmaceutical treatment only
Could I receive a placebo?
No, everyone receives an active treatment
How many people
32 participants
Where
1 siteEgypt
Study dates
30 Aug 2023to 30 Aug 2024
Phase
Interventional
Are there results?
None posted in the registry

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

  • Ages 30 years and older
  • All sexes
  • Healthy volunteers accepted
  • Adult, Older adult

Who may be able to join

  • Patients with parkinson's disease based on established diagnostic criteria complaining of oropharyngeal dysphagia.

Who cannot join

  • Other significant medical conditions: Participants with significant medical conditions that could confound the assessment of dysphagia or its causes may be excluded.
  • Prior surgical interventions or interventions affecting swallowing.
  • Cognitive impairment: Parkinson's patients with severe cognitive impairments

Trial locations and contacts

1 site in 1 country.

Egypt1 site
  • Tanta University

    Tanta

Other trials in Egypt

About this study

Official title: Evaluation of the Results of Combined Medical and Swallowing Behavioral Readjustment Therapy in Oropharyngeal Dysphagia Management Among Parkinson's Patients

The study aims to assess the efficacy of using swallowing behavioral readjustment technique in combination with medical treatment in management of oropharyngeal dysphagia among Parkinson's patients in order to improve the management protocol

Read the detailed description

Parkinson's disease is the second most common neurodegenerative disorder with an estimated prevalence of 6.1 million individuals all over the world.

Parkinson's disease is characterized by motor features such as tremor, rigidity and bradykinesia, and several non-motor features such as dysphagia, autonomic dysfunction, sleep disorders, cognitive impairment, depression, and psychosis that may occur at any time during the disease course, but become more frequent with advanced disease. Dysphagia in Parkinson's disease is a manifestation of swallowing dysfunction that may involve oral, pharyngeal or esophageal phases of swallowing and may be present in every stage of the disease. Indeed, even though swallowing disorders become apparent mostly in the advanced stage of Parkinson's disease, they may already be present in the early stages, when they often go undetected.

The mechanism of dysphagia in Parkinson's disease is unclear. Studies have shown that in the progression of Parkinson's disease, a variety of pathological changes occur in the neuromuscular associated with swallowing function, resulting in impaired central and peripheral swallowing regulation mechanisms, and eventually swallowing disorders (.Both dopaminergic and non-dopaminergic mechanisms can be involved in dysphagia pathophysiology of parkinsonian syndromes In this regard, bradykinetic swallowing abnormalities, related to the nigrostriatal dopamine deficiency, are commonly observed as early findings of dysphagia in these disorders.

Parkinson's disease can impair all phases of swallowing. Dysphagia in the oral phase of Parkinson's disease patients is characterized by difficulties in the initiation of swallow, oral residues, piecemeal swallow and premature falling of the food; the pharyngeal phase is characterized by regurgitation of food into the nasal cavity or upper pharynx, pharyngeal residue and penetration/aspiration, and the esophageal phase is characterized by reduced esophageal peristalsis. Another distinctive feature in parkinsonian syndromes is the incomplete or absent relaxation of the cricopharyngeal muscle during the pharyngeal phase of swallowing, as possible consequence of brainstem involvement mostly in the advanced stages .Also there is recent evidence suggesting that time-to-laryngeal vestibule closure and airway responses to penetrated material are impacted by Parkinson's disease , greater evidence is needed to elucidate those physiological impairments for which treatment might have the greatest impact for swallowing safety and efficiency .

Treatments of dysphagia in Parkinson's disease include pharmaceutical, rehabilitation approaches and surgical . Pharmaceutical treatment is usually performed by the prescription of different dopaminergic medication ( levodopa, carbidopa , apomorphine , domperidone , and rotigotine . The effects of pharmaceutical treatment on improving motor functions of patients with Parkinson's disease are well demonstrated. However, contradictory results are reported on the effectiveness of pharmaceutical treatment on the swallowing function of patients with Parkinson's disease . As it has been suggested for many years that swallowing dysfunction is not related to nigrostriatal dopamine deficiency and may have a non-dopaminergic influence. Also there is botulinum toxin therapy which is new technique in patients who have well documented upper esophageal sphincter impairment . Another technique is botulinum toxin injection in parotid glands which leads to decrease sialorrhoea in patients with Parkinson's disease, but it has no effect on improving the swallowing function .

The study aims to assess the efficacy of using swallowing behavioral readjustment technique in combination with medical treatment in management of oropharyngeal dysphagia among Parkinson's patients in order to improve the management protocol

Being tested
combined pharmaceutical treatment and rehabilitation techniques, pharmaceutical treatment only
Keywords
Swallowing Behavioral Readjustment, Medical, Dysphagia, Oropharyngeal, Management
Medical subject headings
Deglutition Disorders

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • combined pharmaceutical treatment and rehabilitation techniquesBehavioural

    Group (A) managed by combined pharmaceutical treatment and rehabilitation techniques for 6 months .

  • pharmaceutical treatment onlyDrug

    Group (B) managed by pharmaceutical treatment only

Study groups in NCT07618637
Study groupRoleWhat they receive
Group (A)ExperimentalPatients managed by combined pharmaceutical treatment and rehabilitation techniques for 6 months .
Receives: Behavioral: combined pharmaceutical treatment and rehabilitation techniques
Group (B)ExperimentalPatients managed by pharmaceutical treatment only
Receives: Drug: pharmaceutical treatment only

What is being measured

The primary outcome is the main question the study is designed to answer.

  1. Fiberoptic Endoscopic Evaluation of Swallowing

    Fiberoptic Endoscopic Evaluation of Swallowing involves passing a flexible endoscope through the nose to visualize the swallowing process directly. It allows for a detailed assessment of the structures involved in swallowing and can detect abnormalities or dysfunctions, such as reduced laryngeal elevation or penetration/ aspiration events .

    Measured: 6 months

Secondary outcomes (1)
  1. Complications as bleeding

    Measured: 6 months

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted1 Jun 2026
  2. Study start30 Aug 2023
  3. Primary completion30 Aug 2024
  4. Study completion30 Aug 2024

Resources

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design
Study type
Interventional
Phase
Phase N/A
Primary purpose
Treatment
Allocation
Non-randomised
Intervention model
Parallel groups
Masking
None (open label)
Enrolment
32 participants (actual)
IDs, dates and publications
ClinicalTrials.gov ID
NCT07618637
Sponsor's protocol ID
36264MS290/8/23
Status last verified
Aug 2023
First submitted
25 May 2026
Last updated
1 Jun 2026
Results posted
No
Data monitoring committee
No
FDA-regulated drug
No
FDA-regulated device
No
Individual data sharing
Yes: It will be available if it needed

Questions about this trial

What is this clinical trial studying?

A study testing combined pharmaceutical treatment and rehabilitation techniques and pharmaceutical treatment only in people with Oropharyngeal Dysphagia (OPD) and Parkinson, run by Tanta University at 1 site in Egypt.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 1 inclusion and 3 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: finished, as of the sponsor's last update on 1 Jun 2026. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 1 site in Egypt. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

Are results available for this study?

The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.

How can a doctor refer a patient or contact the research team?

The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Fiberoptic Endoscopic Evaluation of Swallowing (time frame: 6 months). It is what the study was designed to measure, not a finding.

Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 1 Jun 2026.

Free account

Log in to keep searching

You’ve used your 3 free searches. AzTrials is free: log in or create a free account to keep searching clinical trials and save the ones you want to follow.

Create a free accountLog in