Sleep, Awake & Move - Part I (SA&M-I)
|
The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details. |
| ClinicalTrials.gov Identifier: NCT02723396 |
|
Recruitment Status : Unknown
Verified August 2018 by Pietro Luca Ratti, Neurocenter of Southern Switzerland.
Recruitment status was: Recruiting
First Posted : March 30, 2016
Last Update Posted : August 27, 2018
|
- Study Details
- Tabular View
- No Results Posted
- Disclaimer
- How to Read a Study Record
| Condition or disease |
|---|
| Idiopathic Parkinson Disease |
The "Sleep & Move" study is the first part of the Sleep, Awake & Move project. In this observational study we plan to systematically investigate SB and the day-to-day variation in this phenomenon in PD patients by a prospective, repeated assessment for 14 days of both subjective and objective measures of motor function and sleep at patients' home, by an Android app developed ad hoc by our group and named "SleepFit".
Since is still unknown if a spontaneous, subclinical improvement in motor performance might also occur in healthy subjects or if the SB is a phenomenon only involving subjects with PD, we had the idea to test this hypothesis comparing a subgroup of PD patients with age- and sex-matched healthy volunteers, employing the same assessments as in the Sleep & Move study.
| Study Type : | Observational |
| Estimated Enrollment : | 80 participants |
| Observational Model: | Ecologic or Community |
| Time Perspective: | Prospective |
| Official Title: | Sleep & Move. Systematic Characterisation of Sleep Benefit in Parkinson's Disease. An Observational, Prospective Study |
| Actual Study Start Date : | March 16, 2016 |
| Estimated Primary Completion Date : | May 31, 2019 |
| Estimated Study Completion Date : | June 30, 2019 |
| Group/Cohort |
|---|
|
Parkinson
Prospective observation of a cohort of consecutive patients with idiopathic PD in an ecological setting.
|
|
Healthy
The same assessments will be performed in a subgroup of age- and sex-matched healthy volunteers.
|
- Objective prospective and repeated assessment of motor function [ Time Frame: from day 0 to day 15 ]Finger tapping test
- Objective prospective and repeated assessment of motor function [ Time Frame: from day 0 to day 15 ]Tri-axial accelerometry (from wrist actigraphy)
- Subjective prospective and repeated assessment of motor function [ Time Frame: from day 0 to day 15 ]Visual analogue scale (VAS)
- Objective prospective assessment of sleep and wakefulness [ Time Frame: from day 0 to day 15 ]Wrist actigraphy
- Subjective prospective assessment of sleep and wakefulness [ Time Frame: from day 0 to day 15 ]Electronic sleep diary
- Subjective prospective assessment of sleepiness [ Time Frame: from day 0 to day 15 ]Stanford Sleepiness Scale (SSS)
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the contacts provided below. For general information, Learn About Clinical Studies.
| Ages Eligible for Study: | 35 Years and older (Adult, Older Adult) |
| Sexes Eligible for Study: | All |
| Accepts Healthy Volunteers: | Yes |
| Sampling Method: | Non-Probability Sample |
Outpatients with mild to moderate idiopathic Parkinson's Disease
Control group (n=30): age-and sex-matched healthy volunteers, matched with the first 30 subjects with Parkinson's Disease enrolled in the study and with a complete dataset available.
PARKINSON'S DISEASE GROUP:
Inclusion Criteria:
- 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:
Inclusion Criteria:
- Absence of Parkinson's disease
- Mentally and physically capable to give informed consent
ALL SUBJECTS:
Exclusion Criteria:
- 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)
- Alcohol abuse
- Other clinically significant severe concomitant disease states
- Inability to follow the procedures of the study (e.g. due to language problems, psychological disorders, etc.)
- Participation in another study with investigational drug within the 60 days preceding and during the present project.
To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT02723396
| Contact: Pietro Luca Ratti, MD, PhD | +41(0)918116849 | PietroLuca.Ratti@eoc.ch | |
| Contact: Francesco Mezzanotte, PhD | +41(0)918116374 | Francesco.Mezzanotte@eoc.ch |
| Switzerland | |
| Sleep and Epilepsy center Department of Neurology, Neurocenter of Southern Switzerland | Recruiting |
| Lugano, Switzerland, 6903 | |
| Contact: Pietro Luca Ratti, MD, PhD +41(0)918116849 PietroLuca.Ratti@eoc.ch | |
| Contact: Francesco Mezzanotte, PhD +41(0)918116374 Francesco.Mezzanotte@eoc.ch | |
| Principal Investigator: Pietro Luca Ratti, MD, PhD | |
| Sub-Investigator: Alain Kälin-Lang, Pr, MD, PhD | |
| Sub-Investigator: Francesco Mezzanotte, Med. Stud. | |
| Sub-Investigator: Paulo Edson Nunes Ferreira | |
| Sub-Investigator: Sandra Hackethal, MD | |
| Principal Investigator: | Pietro Luca Ratti, MD, PhD | Neurocenter of Southern Switzerland |
| Responsible Party: | Pietro Luca Ratti, MD, PhD, Neurocenter of Southern Switzerland |
| ClinicalTrials.gov Identifier: | NCT02723396 |
| Other Study ID Numbers: |
EOC.NSI.LS.15.3.I |
| First Posted: | March 30, 2016 Key Record Dates |
| Last Update Posted: | August 27, 2018 |
| Last Verified: | August 2018 |
| Individual Participant Data (IPD) Sharing Statement: | |
| Plan to Share IPD: | No |
|
Parkinson's disease Sleep Benefit |
|
Parkinson Disease Parkinsonian Disorders Basal Ganglia Diseases Brain Diseases |
Central Nervous System Diseases Nervous System Diseases Movement Disorders Neurodegenerative Diseases |