NCT07118280

Brief Summary

The goal of this observational study is to explore whether oral health and saliva viscosity and composition in Oculopharyngeal Muscular Dystrophy (OPMD) is different from control subjects. The main questions it aims to answer are: Do swallowing disturbances in OPMD adversely affect oral health? Is saliva thickness (viscosity) is increased in OPMD? Does saliva in OPMD contains biochemical markers of the disease?

Trial Health

77
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
100

participants targeted

Target at P50-P75 for all trials

Timeline
10mo left

Started Mar 2023

Longer than P75 for all trials

Geographic Reach
1 country

1 active site

Status
recruiting

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Progress80%
Mar 2023Mar 2027

Study Start

First participant enrolled

March 1, 2023

Completed
2.4 years until next milestone

First Submitted

Initial submission to the registry

August 5, 2025

Completed
7 days until next milestone

First Posted

Study publicly available on registry

August 12, 2025

Completed
1.6 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

March 1, 2027

Expected
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

March 1, 2027

Last Updated

January 27, 2026

Status Verified

January 1, 2026

Enrollment Period

4 years

First QC Date

August 5, 2025

Last Update Submit

January 25, 2026

Conditions

Oculopharyngeal Muscular Dystrophy

Outcome Measures

Primary Outcomes (1)

  • Saliva Viscosity

    Viscosity of unstimulated whole saliva

    Upon enrollment in the study

Secondary Outcomes (1)

  • Oral health indices

    Upon enrollment in the study

Other Outcomes (1)

  • Concentration of Metabolites in saliva

    Upon enrollment in the study

Study Arms (2)

Patients

Patients with OPMD

Control

Unaffected spouse or household member without OPMD

Eligibility Criteria

Age18 Years+
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)
Sampling MethodProbability Sample
Study Population

The Patients group: consisted OPMD patients enrolled in IsrOPMD registry at the multidisciplinary OPMD service at the Sheba Medical Center. The Control group: patients' spouse or household member without OPMD.

You may qualify if:

  • Patients with OPMD and their spouses or household members

You may not qualify if:

  • Pregnancy or presence of any disease that may affect a composition of saliva

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Sheba Medical Center

Ramat Gan, Israel

RECRUITING

Biospecimen

Retention: SAMPLES WITHOUT DNA

Unstimulated whole saliva

MeSH Terms

Conditions

Muscular Dystrophy, Oculopharyngeal

Condition Hierarchy (Ancestors)

Muscular DystrophiesMuscular Disorders, AtrophicMuscular DiseasesMusculoskeletal DiseasesNeuromuscular DiseasesNervous System DiseasesGenetic Diseases, InbornCongenital, Hereditary, and Neonatal Diseases and Abnormalities

Central Study Contacts

Naama Study coordinator

CONTACT

+972 55 2929006opmd@sheba.health.gov.il

Study Design

Study Type
observational
Observational Model
FAMILY BASED
Time Perspective
CROSS SECTIONAL
Target Duration
1 Day
Sponsor Type
OTHER GOV
Responsible Party
SPONSOR

Study Record Dates

First Submitted

August 5, 2025

First Posted

August 12, 2025

Study Start

March 1, 2023

Primary Completion (Estimated)

March 1, 2027

Study Completion (Estimated)

March 1, 2027

Last Updated

January 27, 2026

Record last verified: 2026-01

Locations

IL(1)