NCT02723396Completed
Sleep, Awake & Move - Part I
Sleep & Move. Systematic Characterisation of Sleep Benefit in Parkinson's Disease. An Observational, Prospective Study
Source: ClinicalTrials.gov · Last updated 13 Feb 2024
Brief summary (registry, in English)
Sleep benefit (SB) is a prominent spontaneous, apparently unpredictable, transitory improvement in motor function reported by around 50% of patients affected by Parkinson's Disease (PD) after sleep and before taking their first dose of dopaminergic medications. This study aims at systematically characterizing SB in PD patients in an ecological setting and to explore the relationships between nocturnal and diurnal sleep and subjective and objective measures of motor function. A better understanding of this phenomenon is mandatory for future research on this topic.
- Status (registry)
- Completed
- Study type
- Observational
- Enrollment
- 67 (actual)
- First submitted
- 12 Mar 2016
- Start date
- 16 Mar 2016
- Primary completion date
- 31 May 2019
- Lead sponsor
- Neurocenter of Southern Switzerland
- Diseases
- Parkinson disease
- NCT number
- NCT02723396
What you commit to
- Study type: Observational
- Participants enrolled: 67
- From 16 Mar 2016 to the primary completion date, 31 May 2019
- 1 site in 1 country
- Visits and tests: ask the trial team, the registry does not list them
Built from the registry fields of ClinicalTrials.gov. It describes the study, not your situation.
Who cannot take part
Copied verbatim from ClinicalTrials.gov and grouped by topic. Only the trial team decides who can take part.
Prior treatment
- Other clinically significant severe concomitant disease states
- Participation in another study with investigational drug within the 60 days preceding and during the present project.
Other illness
- Atypical parkinsonian syndrome
- Cognitive impairment (MMSE ≥ 26)
- History of cerebro-vascular disease, epilepsy, or other disabling neurological diseases
- Psychiatric disorders, excepting mild depression (BDI score \<14)
- Inability to follow the procedures of the study (e.g. due to language problems, psychological disorders, etc.)
Other
- Alcohol abuse
Who the study is looking for
- Diagnostic criteria of idiopathic Parkinson's disease (UKPDBB)
- Mild to moderate disease (Hoehn \& Yahr score ≥ 1 and \<= 3)
- Mentally and physically capable to give informed consent
- Stable antiparkinsonian and psychotropic therapy for the last 30 days
- HEALTHY GROUP:
- Absence of Parkinson's disease
- Mentally and physically capable to give informed consent
- ALL SUBJECTS:
Criteria the registry did not label
- PARKINSON'S DISEASE GROUP:
Age in the registry: 35 years to - · Sex: All · Accepts healthy volunteers
Sites (1)
Sites in registry order. Pick your city on the disease page to sort them by distance.
| Site | City | Country | Site status |
|---|---|---|---|
| Sleep and Epilepsy center Department of Neurology, Neurocenter of Southern Switzerland Coordinator of this site? Confirm its status | Lugano | Switzerland | Unknown status |
This page is information, not medical advice. Discuss any trial with your doctor.