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Trial · NCT07294469

Registered outcomes12

Each outcome the trial registered, primary first, in ClinicalTrials.gov's words.

ListOutcomeTime frameDescription
PrimaryUnified Parkinson's Disease Rating Scale (UPDRS) I,II,IIIEvaluations will be conducted at the time of randomization and will serve as baseline data.
The UPDRS is a clinical tool to assess the severity of Parkinson's disease. It consists of: Part I: Mentation, Behavior, and Mood (cognitive and psychiatric symptoms); Part II: Activities of Daily Living (self-reported motor activities); Part III: Motor Examination (clinician-assessed motor symptoms); The combined score of Parts I, II, and III reflects overall disease severity.
PrimaryUnified Parkinson's Disease Rating Scale (UPDRS) I,II,IIIEvaluations will be conducted at the fourth week after the start of the intervention.
The UPDRS is a clinical tool to assess the severity of Parkinson's disease. It consists of: Part I: Mentation, Behavior, and Mood (cognitive and psychiatric symptoms); Part II: Activities of Daily Living (self-reported motor activities); Part III: Motor Examination (clinician-assessed motor symptoms); The combined score of Parts I, II, and III reflects overall disease severity.
PrimaryUnified Parkinson's Disease Rating Scale (UPDRS) I,II,IIIEvaluations will be conducted at the fourth week after the end of the intervention, i.e. the eighth week after start of intervention.
The UPDRS is a clinical tool to assess the severity of Parkinson's disease. It consists of: Part I: Mentation, Behavior, and Mood (cognitive and psychiatric symptoms); Part II: Activities of Daily Living (self-reported motor activities); Part III: Motor Examination (clinician-assessed motor symptoms); The combined score of Parts I, II, and III reflects overall disease severity.
PrimaryPittsburgh Sleep Quality Index (PSQI)Evaluations will be conducted at the time of randomization and will serve as baseline data.
The PSQI is a self-report questionnaire assessing sleep quality and disturbances over the past month. It consists of 19 items across 7 domains: sleep quality, sleep latency, sleep duration, sleep efficiency, sleep disturbances, use of sleep medication, and daytime dysfunction.
PrimaryPittsburgh Sleep Quality Index (PSQI)Evaluations will be conducted at the fourth week after the start of the intervention.
The PSQI is a self-report questionnaire assessing sleep quality and disturbances over the past month. It consists of 19 items across 7 domains: sleep quality, sleep latency, sleep duration, sleep efficiency, sleep disturbances, use of sleep medication, and daytime dysfunction.
PrimaryPittsburgh Sleep Quality Index (PSQI)Evaluations will be conducted at the fourth week after the end of the intervention, i.e. the eighth week after start of intervention.
The PSQI is a self-report questionnaire assessing sleep quality and disturbances over the past month. It consists of 19 items across 7 domains: sleep quality, sleep latency, sleep duration, sleep efficiency, sleep disturbances, use of sleep medication, and daytime dysfunction.
SecondaryParkinson's Disease Sleep Scale-2 (PDSS-2)Evaluations will be conducted at the time of randomization and will serve as baseline data.
The PDSS-2 is a self-reported tool designed to assess sleep disturbances specifically in individuals with Parkinson's disease. It includes 15 items covering various sleep-related issues such as sleep onset, duration, nocturnal motor symptoms, and daytime sleepiness.
SecondaryParkinson's Disease Sleep Scale-2 (PDSS-2)Evaluations will be conducted at the fourth week after the start of the intervention.
The PDSS-2 is a self-reported tool designed to assess sleep disturbances specifically in individuals with Parkinson's disease. It includes 15 items covering various sleep-related issues such as sleep onset, duration, nocturnal motor symptoms, and daytime sleepiness.
SecondaryParkinson's Disease Sleep Scale-2 (PDSS-2)Evaluations will be conducted at the fourth week after the end of the intervention, i.e. the eighth week after start of intervention.
The PDSS-2 is a self-reported tool designed to assess sleep disturbances specifically in individuals with Parkinson's disease. It includes 15 items covering various sleep-related issues such as sleep onset, duration, nocturnal motor symptoms, and daytime sleepiness.
SecondaryParkinson's Disease Questionnaire (PDQ-39)Evaluations will be conducted at the time of randomization and will serve as baseline data.
The PDQ-39 is a 39-item self-report questionnaire designed to assess health-related quality of life in people with Parkinson's disease. It covers 8 domains: mobility, activities of daily living, emotional well-being, stigma, social support, cognitions, communication, and sleep.
SecondaryParkinson's Disease Questionnaire (PDQ-39)Evaluations will be conducted at the fourth week after the start of the intervention.
The PDQ-39 is a 39-item self-report questionnaire designed to assess health-related quality of life in people with Parkinson's disease. It covers 8 domains: mobility, activities of daily living, emotional well-being, stigma, social support, cognitions, communication, and sleep.
SecondaryParkinson's Disease Questionnaire (PDQ-39)Evaluations will be conducted at the fourth week after the end of the intervention, i.e. the eighth week after start of intervention.
The PDQ-39 is a 39-item self-report questionnaire designed to assess health-related quality of life in people with Parkinson's disease. It covers 8 domains: mobility, activities of daily living, emotional well-being, stigma, social support, cognitions, communication, and sleep.

Source ClinicalTrials.govtrials-2026-11-12-0.5.0

Sources 3

  • ClinicalTrials.gov's posted results, through CTTI's AACTFreely available. Acknowledgement requested
  • ClinicalTrials.govNo license stated
  • NIH RePORTER's clinical studies and project filesPublic domain
Each source's terms
  • ClinicalTrials.gov's posted results, through CTTI's AACTClinicalTrials.gov data via Aggregate Analysis of ClinicalTrials.gov (AACT), CTTI. CTTI makes its materials freely available and requests acknowledgement. https://aact.ctti-clinicaltrials.org/documentation/299
  • ClinicalTrials.govnone stated
  • NIH RePORTER's clinical studies and project filesPublic domain (NIH RePORTER)

ClinicalTrials.gov's data carry an international copyright outside the United States: https://clinicaltrials.gov/about-site/terms-conditions.

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