Parkinson DiseaseNCT07536490
Sleep Quality, Cognition, and Disease Severity in Parkinson's Disease
An observational study of Parkinson Disease, run by Ankara University at 1 site in Turkey (Türkiye).
Trial summary
The goal of this observational study is to investigate the relationship between sleep quality, cognitive functions, and disease severity in individuals with Parkinson's disease. The main question it aims to answer is: Is sleep quality associated with cognitive function and disease severity in individuals with… Read more about this study
- Who is it for?
- Ages 40 to 65 years
- Conditions the study is for
- Parkinson Disease
- How many people
- 69 participants
- Where
- 1 siteTurkey (Türkiye)
- Study dates
- 10 May 2026to 10 Jun 2026
- Phase
- Observational
- 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 40 to 65 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Study population: The study population will consist of individuals aged 40 to 65 years with Parkinson's disease who are followed at the Neurology Outpatient Clinic of Hacettepe University Faculty of Medicine. Participants who meet the eligibility criteria will be invited to participate in the study.
Who may be able to join
- Age between 40 and 65 years
- Diagnosis of Parkinson's disease confirmed by a neurologist
- Modified Hoehn and Yahr stage between 1 and 3
- Montreal Cognitive Assessment (MoCA) score ≥21
Who cannot join
- Difficulty in verbal communication
- Use of walking aid
- Severe visual impairment or additional neurological disorder
- Presence of congestive heart failure
- Any medical condition preventing participation
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Investigation of the Relationship Between Sleep Quality, Cognitive Functions, and Disease Severity in Patients With Parkinson's Disease
The goal of this observational study is to investigate the relationship between sleep quality, cognitive functions, and disease severity in individuals with Parkinson's disease. The main question it aims to answer is:
Is sleep quality associated with cognitive function and disease severity in individuals with Parkinson's disease?
Participants will complete assessments of sleep quality, cognitive function, disease severity, and disease stage during a single evaluation session. Cognitive function will be evaluated using the Stroop Test, Clock Drawing Test, and Montreal Cognitive Assessment. Disease severity will be assessed using the Unified Parkinson's Disease Rating Scale, and disease stage will be determined using the Modified Hoehn and Yahr Scale.
- Conditions
- Parkinson Disease
- Keywords
- Parkinson Disease, Sleep Quality, Cognitive Function, Disease Severity
- Medical subject headings
- Parkinson Disease, Sleep Initiation and Maintenance Disorders
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
| Study group | Role | What they receive |
|---|---|---|
| Patients with Parkinson Disease | Individuals diagnosed with Parkinson's disease who meet the inclusion criteria and undergo assessment of sleep quality, cognitive function, and disease severity. |
What is being measured
The primary outcome is the main question the study is designed to answer.
Sleep Quality
Sleep quality will be assessed using the Pittsburgh Sleep Quality Index. Total scores range from 0 to 21, with higher scores indicating poorer sleep quality.
Measured: Baseline
Stroop Test
Cognitive flexibility and selective attention will be assessed using the Stroop Test. Completion time and error rates will be recorded, with longer times and higher error rates indicating poorer performance.
Time Frame: Baseline
Measured: Baseline
Clock Drawing Test
Visuospatial ability and executive function will be assessed using the Clock Drawing Test. Scores will be recorded based on standard scoring criteria, with lower scores indicating impaired performance.
Measured: Baseline
Disease Severity
Disease severity will be assessed using the Unified Parkinson's Disease Rating Scale. Higher scores indicate greater disease severity.
Measured: Baseline
Secondary outcomes (2)
Montreal Cognitive Assessment
Global cognitive function will be assessed using the Montreal Cognitive Assessment. Total scores range from 0 to 30, with lower scores indicating greater cognitive impairment.
Measured: Baseline
Disease Stage
Disease stage will be determined using the Modified Hoehn and Yahr Scale. Higher stages indicate more advanced disease.
Measured: Baseline
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted17 Apr 2026
- Study start10 May 2026
- Primary completion1 Jun 2026
- Study completion10 Jun 2026
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Parkinson DiseaseStudies of the same condition, open and under way.
- More trials run by Ankara 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
- Cross-sectional
- Enrolment
- 69 participants (actual)
Sponsor and investigators
- Lead sponsor
- Ankara University
- Sponsor type
- University, hospital or other
- Collaborators
- Hacettepe University
- Responsible party
- Principal investigator, Büşra Seçkinoğulları Korkusuz, Ankara University
- Investigators
- Süleyman Korkusuz, Study chair, Atılım UniversityAyla Fil, Study chair, Hacettepe UniversityGül Yalçın Çakmaklı, Study chair, Hacettepe UniversityBüşra Seçkinoğulları Korkusuz, Principal investigator, Ankara University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07536490
- Sponsor's protocol ID
- E-59394181-604.01-113629
- Status last verified
- Apr 2026
- First submitted
- 11 Apr 2026
- Last updated
- 16 Jun 2026
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 16 Jun 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Investigation of the Relationship Between Sleep Quality, Cognitive Functions, and Disease Severity in Patients With Parkinson's Disease
- ClinicalTrials.gov ID
- NCT07536490
- Acronym / sponsor ID
- E-59394181-604.01-113629
- Conditions
- Parkinson Disease
- Keywords
- Parkinson Disease, Sleep Quality, Cognitive Function, Disease Severity
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 69 participants (actual)
- Lead sponsor
- Ankara UniversityUniversity, hospital or other
- Collaborators
- Hacettepe University
- Study start
- 10 May 2026 (actual)
- Primary completion
- 1 Jun 2026 (actual)
- Study completion
- 10 Jun 2026 (actual)
- First posted
- 17 Apr 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.
The goal of this observational study is to investigate the relationship between sleep quality, cognitive functions, and disease severity in individuals with Parkinson's disease. The main question it aims to answer is:
Is sleep quality associated with cognitive function and disease severity in individuals with Parkinson's disease?
Participants will complete assessments of sleep quality, cognitive function, disease severity, and disease stage during a single evaluation session. Cognitive function will be evaluated using the Stroop Test, Clock Drawing Test, and Montreal Cognitive Assessment. Disease severity will be assessed using the Unified Parkinson's Disease Rating Scale, and disease stage will be determined using the Modified Hoehn and Yahr Scale.
Study design
- Observational model
- Cohort
- Time perspective
- Cross-sectional
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Patients with Parkinson Disease | – | –Individuals diagnosed with Parkinson's disease who meet the inclusion criteria and undergo assessment of sleep quality, cognitive function, and disease severity. |
Who may qualify
- Ages
- 40 to 65 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- The study population will consist of individuals aged 40 to 65 years with Parkinson's disease who are followed at the Neurology Outpatient Clinic of Hacettepe University Faculty of Medicine. Participants who meet the eligibility criteria will be invited to participate in the study.
Key inclusion criteria (4 listed)
- Age between 40 and 65 years
- Diagnosis of Parkinson's disease confirmed by a neurologist
- Modified Hoehn and Yahr stage between 1 and 3
- Montreal Cognitive Assessment (MoCA) score ≥21
Key exclusion criteria (5 listed)
- Difficulty in verbal communication
- Use of walking aid
- Severe visual impairment or additional neurological disorder
- Presence of congestive heart failure
- Any medical condition preventing participation
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
Sleep Quality
Time frame: Baseline
Sleep quality will be assessed using the Pittsburgh Sleep Quality Index. Total scores range from 0 to 21, with higher scores indicating poorer sleep quality.
Stroop Test
Time frame: Baseline
Cognitive flexibility and selective attention will be assessed using the Stroop Test. Completion time and error rates will be recorded, with longer times and higher error rates indicating poorer performance. Time Frame: Baseline
Clock Drawing Test
Time frame: Baseline
Visuospatial ability and executive function will be assessed using the Clock Drawing Test. Scores will be recorded based on standard scoring criteria, with lower scores indicating impaired performance.
Disease Severity
Time frame: Baseline
Disease severity will be assessed using the Unified Parkinson's Disease Rating Scale. Higher scores indicate greater disease severity.
2 secondary outcomes
Montreal Cognitive Assessment
Time frame: Baseline
Disease Stage
Time frame: Baseline
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 16 Jun 2026.
- Individual participant dataSharing planned: No
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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. This study is not recruiting at the moment.
Süleyman Korkusuz study chair
Atılım University
Ayla Fil study chair
Hacettepe University
Gül Yalçın Çakmaklı study chair
Hacettepe University
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Parkinson Disease, run by Ankara University at 1 site in Turkey (Türkiye).
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 4 inclusion and 5 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 16 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 Turkey (Türkiye). 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?
Sleep Quality (time frame: Baseline). The study lists 4 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 16 Jun 2026.