Idiopathic Parkinson's DiseaseNCT05687799
Fatigue, Sleep and Quality of Life in Parkinson's Patients
An observational study of Idiopathic Parkinson's Disease, run by Nigde Omer Halisdemir University at 1 site in Turkey (Türkiye).
Trial 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. Read more about this study
- Who is it for?
- Ages 50 years and older
- Conditions the study is for
- Idiopathic Parkinson's Disease
- How many people
- 61 participants
- Where
- 1 siteTurkey (Türkiye)
- Study dates
- 22 Dec 2022to 22 Mar 2023
- 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 50 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Study population: Parkinson's patients who applied to Nigde Omer Halisdemir University Training and Research Hospital Neurology Clinic will be included in this study.
Who may be able to join
- 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
Who cannot join
- Having an additional or psychiatric disease other than Parkinson's disease
- Lack of cooperation
- Presence of orthopedic problems (such as fractures, osteoporosis, osteomyelitis)
Trial locations and contacts
1 site in 1 country.
Turkey (Türkiye)1 site
Nigde Omer Halisdemir University Treaning and Research Hospital
Niğde, 51200
About this study
Official title: The Relationship of Neutrophil/Lymphocyte Ratio With Fatigue, Sleep and Quality of Life in Parkinson's Patients
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.
Read the detailed description
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.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. A total of 39 Parkinson's Disease age of older the 50 participate in the research.
- Conditions
- Idiopathic Parkinson's Disease
- Keywords
- Parkinson's disease, Quality of life, Neutrophil/Lymphocyte ratio, Quality of sleep, Fatigue
- Medical subject headings
- Parkinson Disease, Sleep Initiation and Maintenance Disorders, Fatigue
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: Baseline
Hemogram
The neutrophil/lymphocyte ratio is a marker of peripheral inflammation.
Measured: 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.
Measured: 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.
Measured: Baseline
Secondary outcomes (2)
Unified Parkinson's Disease Rating Scale
This scale was created to evaluate the motor performance, mental and mental status, and activities of daily living of Parkinson's patients. It also evaluates motor fluctuations, dyskinesias, and autonomic dysfunction. The scale was prepared as 4 parts and 42 items. When the extremities are evaluated separately, it increases up to 55 items. Items are rated from 0 (no symptoms or signs) to 4 (most severe symptoms and signs). The first part evaluates the non- motor features of the disease, such as thoughts, behaviors, and emotions. The second part consists of activities of daily living. In the third part, motor examination, in the fourth part, the complications of the treatment are given. It is used to evaluate the symptoms of the disease and the complications that develop due to treatment. In this scale, which consists of 4 parts, the scoring of each item is between 0-4 points. The increase in the total score reflects the increase in the severity of the symptoms.
Measured: Baseline
Modified Hoehn and Yahr Scale
This staging scale was developed by Margaret Hoehn and Melvin Yahr (1967) for use in describing the stage of Parkinson's disease. According to the staging scale, the disease is handled in 8 stages. The lower the stage, the better of the stage Parkinson's disease.
Stage 0: No signs of disease Stage 1: Unilateral disease Stage 1.5: Unilateral plus axial involvement. Stage 2: Bilateral disease, no balance disorder. Stage 2.5: Mild bilateral disease recovering on pull test. Stage 3: Mild to moderate bilateral disease and some postural instability, physically independent.
Stage 4: Severe disability, able to stand and walk unaided. Stage 5: Unassisted wheelchair or bed dependent.
Measured: Baseline
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted18 Jan 2023
- Study start22 Dec 2022
- Primary completion22 Mar 2023
- Study completion22 Mar 2023
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Idiopathic Parkinson's DiseaseStudies of the same condition, open and under way.
- 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
- Case only
- Time perspective
- Prospective
- Enrolment
- 61 participants (actual)
Sponsor and investigators
- Lead sponsor
- Nigde Omer Halisdemir University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Asli Celik, Nigde Omer Halisdemir University
- Investigators
- Dilek İŞCAN, Dr., Principal investigator, Nigde Omer Halisdemir University Treaning and Research Hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05687799
- Sponsor's protocol ID
- 2022/108
- Status last verified
- Apr 2023
- First submitted
- 8 Jan 2023
- Last updated
- 4 Apr 2023
- Results posted
- No
- Data monitoring committee
- Yes
- 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 4 Apr 2023. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- The Relationship of Neutrophil/Lymphocyte Ratio With Fatigue, Sleep and Quality of Life in Parkinson's Patients
- ClinicalTrials.gov ID
- NCT05687799
- Acronym / sponsor ID
- 2022/108
- Conditions
- Idiopathic Parkinson's Disease
- Keywords
- Parkinson's disease, Quality of life, Neutrophil/Lymphocyte ratio, Quality of sleep, Fatigue
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 61 participants (actual)
- Lead sponsor
- Nigde Omer Halisdemir UniversityUniversity, hospital or other
- Study start
- 22 Dec 2022 (actual)
- Primary completion
- 22 Mar 2023 (actual)
- Study completion
- 22 Mar 2023 (actual)
- First posted
- 18 Jan 2023 (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.
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.
Detailed description
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.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. A total of 39 Parkinson's Disease age of older the 50 participate in the research.
Study design
- Observational model
- Case only
- Time perspective
- Prospective
Who may qualify
- Ages
- 50 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- Parkinson's patients who applied to Nigde Omer Halisdemir University Training and Research Hospital Neurology Clinic will be included in this study.
Key inclusion criteria (8 listed)
- 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
Key exclusion criteria (3 listed)
- Having an additional or psychiatric disease other than Parkinson's disease
- Lack of cooperation
- Presence of orthopedic problems (such as fractures, osteoporosis, osteomyelitis)
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
Parkinson's Disease Quality of Life-8
Time frame: Baseline
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.
Hemogram
Time frame: Baseline
The neutrophil/lymphocyte ratio is a marker of peripheral inflammation.
Parkinson's Fatigue Scale-16
Time frame: Baseline
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.
The Parkinson's Disease Sleep Scale
Time frame: Baseline
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.
2 secondary outcomes
Unified Parkinson's Disease Rating Scale
Time frame: Baseline
Modified Hoehn and Yahr Scale
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 4 Apr 2023.
- 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.
Dilek İŞCAN, Dr. principal investigator
Nigde Omer Halisdemir University Treaning and Research Hospital
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 Idiopathic Parkinson's Disease, run by Nigde Omer Halisdemir 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 8 inclusion and 3 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 4 Apr 2023. 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?
Parkinson's Disease Quality of Life-8 (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 4 Apr 2023.