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OpenTrials
Completed

NCT Number: NCT07536490

Sleep Quality, Cognition, and Disease Severity in 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.

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Key information

Conditions

Parkinson Disease Basal Ganglia Diseases Brain Diseases Central Nervous System Diseases Dyssomnias Mental Disorders Movement Disorders Nervous System Diseases Neurodegenerative Diseases Parkinsonian Disorders Sleep Disorders, Intrinsic Sleep Initiation and Maintenance Disorders Sleep Wake Disorders Synucleinopathies

Age range

40 year–65 year

Sex eligibility

All sexes

Study type

Observational

Primary location

Hacettepe University

Ankara, 06810, Turkey (Türkiye)

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

  • 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

Exclusion criteria

  • 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

Treatment and study plan

Primary outcomes

  1. 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.

  2. 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

  3. 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.

  4. Disease Severity

    Time frame: Baseline

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

Secondary outcomes

  1. Montreal Cognitive Assessment

    Time frame: Baseline

    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.

  2. Disease Stage

    Time frame: Baseline

    Disease stage will be determined using the Modified Hoehn and Yahr Scale. Higher stages indicate more advanced disease.

Sponsors and collaborators

Lead sponsor

Ankara University

Other

Collaborators

  • Hacettepe University

Registry information

Official study title

Investigation of the Relationship Between Sleep Quality, Cognitive Functions, and Disease Severity in Patients With Parkinson's Disease

Important dates

Study start
2026
Primary completion
2026
Study completion
2026
First posted
Apr 17, 2026
Registry last updated
Jun 16, 2026

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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