Fatigue, Sleep and Quality of Life in Parkinson's Patients

NCT05687799 | Completed DMC

• 1 other identifier: 2022/108
• Study Type: observational
• Target: 61
• Locations: 1 country
• Sites: 1

Brief Summary

Parkinson's Disease (PD) is a neurodegenerative disease characterized by chronic and progressive loss of dopaminergic neurons in the substantia nigra (SN) pars compacta. Sleep disturbances and fatigue are very common problems in Parkinson's patients. He reported that the frequency of fatigue was 47% in patients with a disease duration of less than five years and 70% in patients with a disease duration of more than five years. Fatigue in PD has been found to be associated with decreased physical activity, decreased functionality, sleep disorders, gait disturbances, motor findings, autonomic findings, increased levodopa dose, and motor fluctuations. Motor and non-motor symptoms in Parkinson's patients affect the individual's ability to perform activities of daily living independently. Impairments in functional status lead to negative consequences on quality of life. PD affects the individual not only physically, but also psychologically and socially.The neutrophil/lymphocyte ratio is a marker of peripheral inflammation. The relationship of peripheral inflammation to quality of sleep, quality of life and fatigue in individuals is unclear. The aim of this study was to investigation fatigue, quality of sleep and quality of life, and the relationship between neutrophil/lymphocyte ratio in Parkinson's patients.

Conditions

Idiopathic Parkinson's Disease

Keywords

Parkinson's disease; Quality of life; Neutrophil/Lymphocyte ratio; Quality of sleep; Fatigue

Outcome Measures

Primary Outcomes (4)

• Parkinson's Disease Quality of Life-8

  One question from each of the eight domains in Parkinson's Disease Quality of Life-39, which are activities of daily living, physical discomfort, cognition, communication, emotional well-being, mobility, social support and stigma, gives the total domain score.Each question is scored between 0-4 points and points are added up. The total score is then divided by the total possible score and given as a percentage point out of 100. The lower the score, the higher the quality of life.

  Baseline

• Hemogram

  The neutrophil/lymphocyte ratio is a marker of peripheral inflammation.

  Baseline

• Parkinson's Fatigue Scale-16

  The scale is the only fatigue scale specific to PD developed by Brown et al. It examines the impact of fatigue on daily life and consists of 16 items designed to assess the physical effects of fatigue. The scale allows to measure the presence of fatigue (seven items) and its effect on daily function (nine items). The subjects are asked to respond to the statements about fatigue between 1 (strongly disagree) and 5 (strongly agree). The higher score, the worsen fatigue scale in participant.

  Baseline

• The Parkinson's Disease Sleep Scale

  Parkinson's Disease Sleep Scale consists of 15 questions to be answered by the patient. With this, the quality of sleep as a whole during the night, difficulty in starting and maintaining sleep, night restlessness, nocturnal psychosis, nocturia, nocturnal motor symptoms, restlessness of sleep and naps during the day can be evaluated. The test is done by giving a score between 0 (very severe complaints) and 10 (no complaints) for each question. The total score point is 150. Higher scores indicate better sleep quality.

  Baseline

Secondary Outcomes (2)

• Unified Parkinson's Disease Rating Scale

  Baseline

• Modified Hoehn and Yahr Scale

  Baseline

Other Outcomes (1)

• Standardized Mini Mental Test

  Baseline

Eligibility Criteria

• Age: 50 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)
• Sampling Method: Non-Probability Sample

Study Population

Parkinson's patients who applied to Nigde Omer Halisdemir University Training and Research Hospital Neurology Clinic will be included in this study.

You may qualify if:

• Being diagnosed with idiopathic Parkinson's disease
• Healthy individuals who do not have musculoskeletal disease or any neurological disease that may affect assessments
• Older than 50 years old
• Volunteer to participate in the study
• Grade 1-3 on the Modified Hoehn-Yahr Scale
• To have a score above 24 in the Standardized Mini Mental Test
• To have a hemogram follow-up in the last 1 month before the date of participation in the study.
• Being able to walk independently on flat ground

You may not qualify if:

• Having an additional or psychiatric disease other than Parkinson's disease
• Lack of cooperation
• Presence of orthopedic problems (such as fractures, osteoporosis, osteomyelitis)

Sponsors & Collaborators

• Nigde Omer Halisdemir University: lead

Study Sites (1)

Nigde Omer Halisdemir University Treaning and Research Hospital

Niğde, 51200, Turkey (Türkiye)

Location

MeSH Terms

Conditions

Parkinson Disease; Sleep Initiation and Maintenance Disorders; Fatigue

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; Signs and Symptoms; Pathological Conditions, Signs and Symptoms

Study Officials

• Dilek İŞCAN, Dr.

  Nigde Omer Halisdemir University Treaning and Research Hospital

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: observational
• Observational Model: CASE ONLY
• Time Perspective: PROSPECTIVE
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: MSc. Lecturer

Study Record Dates

• First Submitted: January 8, 2023
• First Posted: January 18, 2023
• Study Start: December 22, 2022
• Primary Completion: March 22, 2023
• Study Completion: March 22, 2023
• Last Updated: April 4, 2023

Record last verified: 2023-04

Data Sharing

• IPD Sharing: Will not share

Locations

TU (1)