Sleep Quality, Cognition, and Disease Severity in Parkinson's Disease

NCT07536490 | Not Yet Recruiting

• 1 other identifier: E-59394181-604.01-113629
• Study Type: observational
• Target: 75
• Locations: 1 country
• Sites: 1

Brief 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 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

Outcome Measures

Primary Outcomes (4)

• 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.

  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

  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.

  Baseline

• Disease Severity

  Disease severity will be assessed using the Unified Parkinson's Disease Rating Scale. Higher scores indicate greater disease severity.

  Baseline

Secondary Outcomes (2)

• Montreal Cognitive Assessment

  Baseline

• Disease Stage

  Baseline

Study Arms (1)

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.

Eligibility Criteria

• Age: 40 Years - 65 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)
• Sampling Method: Non-Probability Sample

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.

You may qualify if:

• 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

You may not qualify if:

• 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

Sponsors & Collaborators

• Ankara University: lead
• Hacettepe University: collaborator

Study Sites (1)

Hacettepe University

Ankara, Ankara, 06810, Turkey (Türkiye)

Location

MeSH Terms

Conditions

Parkinson Disease; Sleep Initiation and Maintenance Disorders

Condition Hierarchy (Ancestors)

Parkinsonian Disorders; Basal Ganglia Diseases; Brain Diseases; Central Nervous System Diseases; Nervous System Diseases; Movement Disorders; Synucleinopathies; Neurodegenerative Diseases; Sleep Disorders, Intrinsic; Dyssomnias; Sleep Wake Disorders; Mental Disorders

Study Officials

• Süleyman Korkusuz

  Atılım University

  STUDY CHAIR

• Ayla Fil

  Hacettepe University

  STUDY CHAIR

• Gül Yalçın Çakmaklı

  Hacettepe University

  STUDY CHAIR

• Büşra Seçkinoğulları Korkusuz

  Ankara University

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Büşra Seçkinoğulları Korkusuz, PhD

CONTACT

+905442436914; bskorkusuz@ankara.edu.tr

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: CROSS SECTIONAL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Principal Investigator

Study Record Dates

• First Submitted: April 11, 2026
• First Posted: April 17, 2026
• Study Start (Estimated): May 15, 2026
• Primary Completion (Estimated): August 15, 2026
• Study Completion (Estimated): September 15, 2026
• Last Updated: April 17, 2026

Record last verified: 2026-04

Data Sharing

• IPD Sharing: Will not share

Locations

TU (1)