Parkinson's DiseaseNCT07622303
Depression, Anxiety and Sleep in Parkinson's Disease
An observational study of Parkinson's Disease, run by Sohag University.
Trial summary
This study aims to assess the prevalence and severity of depression, anxiety, and sleep disorders among patients with idiopathic Parkinson's disease. The study will evaluate the relationship between neuropsychiatric symptoms and disease characteristics in order to improve early recognition and patient quality of life. Read more about this study
- Who is it for?
- Ages 50 years and older
- Conditions the study is for
- Parkinson's Disease
- How many people
- 100 participants
- Where
- No sites listed yet
- Study dates
- 1 Jun 2026to 31 May 2027
- Phase
- Observational
- Are there results?
- Not yet: the study is under way
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 50 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Study population: Adult patients aged 50 years and older with idiopathic Parkinson's disease attending the Neurology Outpatient Clinic and/or admitted to the Neurology Department of Sohag University Hospital. A total of 100 eligible patients will be recruited to assess depression, anxiety, and sleep disorders.
A-Inclusion Criteria:
- Patients diagnosed with idiopathic Parkinson's disease according to the Movement Disorder Society Clinical Diagnostic Criteria for Parkinson's Disease (Postuma et al., 2015).
- Age ≥ 50 years.
- Ability to understand and respond to questionnaires and rating scales.
- Ability and willingness to provide informed consent.
B-Exclusion Criteria:
- Patients with atypical parkinsonism.
- Patients with a history of other major neurological disorders (e.g., stroke, Alzheimer's disease, multiple sclerosis).
- Patients with severe cognitive impairment or dementia that prevents reliable completion of rating scales.
- Patients with a current diagnosis of severe psychiatric disorders unrelated to 5-Parkinson's disease (e.g., schizophrenia, bipolar disorder).
6-Patients with unstable medical conditions. 7-Patients unable or unwilling to provide informed consent.
About this study
Official title: Assessment of Depression , Anxiety and Sleep Disorders in Patients With Idiopathic Parkinson's Disease
This study aims to assess the prevalence and severity of depression, anxiety, and sleep disorders among patients with idiopathic Parkinson's disease. The study will evaluate the relationship between neuropsychiatric symptoms and disease characteristics in order to improve early recognition and patient quality of life.
- Conditions
- Parkinson's Disease
- Medical subject headings
- Parkinson Disease
What is being measured
The primary outcome is the main question the study is designed to answer.
Assessment of Depression Severity in Patients with idiopathic Parkinson's Disease
Depression severity measured using the Hamilton Depression Rating Scale (HAM-D). Scores range from 0 to 52, with higher scores indicating more severe depression.
Measured: Baseline assessment during study enrollment.
Assessment of Anxiety Severity in Patients with idiopathic Parkinson's Disease
Anxiety severity measured using the Hamilton Anxiety Rating Scale (HAM-A). Scores range from 0 to 56, with higher scores indicating more severe anxiety.
Measured: Baseline
Assessment of Sleep Disturbance in Patients with idiopathic Parkinson's Disease
Sleep disturbance measured using the Parkinson's Disease Sleep Scale (PDSS). Higher scores indicate better sleep quality and fewer sleep-related symptoms.
Measured: Baseline
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted3 Jun 2026
- Study start1 Jun 2026 (estimated)
- Primary completion28 Feb 2027 (estimated)
- Study completion31 May 2027 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Parkinson's DiseaseStudies of the same condition, open and under way.
- More trials run by Sohag UniversityThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Cohort
- Time perspective
- Prospective
- Enrolment
- 100 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Sohag University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Aya Noureldin Mohamed, Sohag University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07622303
- Sponsor's protocol ID
- Soh-Med-26-5-4MS
- Status last verified
- May 2026
- First submitted
- 24 May 2026
- Last updated
- 9 Jun 2026
- Results posted
- No
Study at a glance
From the registry record, last updated by the sponsor on 9 Jun 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Assessment of Depression , Anxiety and Sleep Disorders in Patients With Idiopathic Parkinson's Disease
- ClinicalTrials.gov ID
- NCT07622303
- Acronym / sponsor ID
- Soh-Med-26-5-4MS
- Conditions
- Parkinson's Disease
- Study type
- Observational
- Recruitment status
- Not yet recruiting
- Enrolment
- 100 participants (estimated)
- Lead sponsor
- Sohag UniversityUniversity, hospital or other
- Study start
- 1 Jun 2026 (estimated)
- Primary completion
- 28 Feb 2027 (estimated)
- Study completion
- 31 May 2027 (estimated)
- First posted
- 3 Jun 2026 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
This study aims to assess the prevalence and severity of depression, anxiety, and sleep disorders among patients with idiopathic Parkinson's disease. The study will evaluate the relationship between neuropsychiatric symptoms and disease characteristics in order to improve early recognition and patient quality of life.
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
Who may qualify
- Ages
- 50 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- Adult patients aged 50 years and older with idiopathic Parkinson's disease attending the Neurology Outpatient Clinic and/or admitted to the Neurology Department of Sohag University Hospital. A total of 100 eligible patients will be recruited to assess depression, anxiety, and sleep disorders.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Primary outcome
Assessment of Depression Severity in Patients with idiopathic Parkinson's Disease
Time frame: Baseline assessment during study enrollment.
Depression severity measured using the Hamilton Depression Rating Scale (HAM-D). Scores range from 0 to 52, with higher scores indicating more severe depression.
Assessment of Anxiety Severity in Patients with idiopathic Parkinson's Disease
Time frame: Baseline
Anxiety severity measured using the Hamilton Anxiety Rating Scale (HAM-A). Scores range from 0 to 56, with higher scores indicating more severe anxiety.
Assessment of Sleep Disturbance in Patients with idiopathic Parkinson's Disease
Time frame: Baseline
Sleep disturbance measured using the Parkinson's Disease Sleep Scale (PDSS). Higher scores indicate better sleep quality and fewer sleep-related symptoms.
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 9 Jun 2026.
Related trials for Parkinson's Disease
Enrolling by invitationObservational study
Early Molecular Biomarkers for Differentiating Parkinsonian Syndromes
PARKINSON DISEASE (Disorder), Atypical Parkinsonism
Active, not recruitingPhase 1/2
Clinical Safety and Efficacy of Umbilical Cord Mesenchymal Stromal Cells-derived Exosomes in Patients With Parkinson's Disease
Parkinson Disease (PD)
Active, not recruitingObservational study
Adaptive DBS to Offset STN Dysregulation During Exercise in PD
Parkinson Disease
Not yet recruiting
Compulsive Eating and Brain's Reward System in Different Pathologies
PARKINSON DISEASE (Disorder), Bipolar 1 Disorder
Not yet recruiting
Evaluating the Effect of the Zeen Mobility Device on Clinical Practicality, Safety, and Impact (Via Assessments of Walking, Standing Tolerance, Balance, Endurance, Effort, and Participation in Daily Tasks) in an Outpatient Rehabilitation Setting for Individuals With Mobility Impairments.
Stroke, Parkinson's Disease (PD)
Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part.
The record lists no contact. Use the official record to reach the sponsor.
Questions about this trial
What is this clinical trial studying?
An observational study of Parkinson's Disease, run by Sohag University.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
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: opening soon, as of the sponsor's last update on 9 Jun 2026. Status can change between updates, so confirm with the study contact before making plans.
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?
This study is still under way. Results are not available in the source record yet.
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?
Assessment of Depression Severity in Patients with idiopathic Parkinson's Disease (time frame: Baseline assessment during study enrollment.). The study lists 3 primary outcomes in all. 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 9 Jun 2026.