Sleep, Awake & Move - Part I (SA&M-I)

February 9, 2024 updated by: Pietro Luca Ratti, Neurocenter of Southern Switzerland

Sleep & Move. Systematic Characterisation of Sleep Benefit in Parkinson's Disease. An Observational, Prospective Study

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.

Study Overview

Status

Completed

Conditions

Detailed Description

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

Enrollment (Actual)

67

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • Switzerland
      • Lugano, Switzerland, 6903
        • Sleep and Epilepsy center Department of Neurology, Neurocenter of Southern Switzerland

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

35 years and older (Adult, Older Adult)

Accepts Healthy Volunteers

Yes

Sampling Method

Non-Probability Sample

Study Population

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.

Description

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.

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

Cohorts and Interventions

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.

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Objective prospective and repeated assessment of motor function
Time Frame: from day 0 to day 15
Finger tapping test
from day 0 to day 15

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Objective prospective and repeated assessment of motor function
Time Frame: from day 0 to day 15
Tri-axial accelerometry (from wrist actigraphy)
from day 0 to day 15
Subjective prospective and repeated assessment of motor function
Time Frame: from day 0 to day 15
Visual analogue scale (VAS)
from day 0 to day 15
Objective prospective assessment of sleep and wakefulness
Time Frame: from day 0 to day 15
Wrist actigraphy
from day 0 to day 15
Subjective prospective assessment of sleep and wakefulness
Time Frame: from day 0 to day 15
Electronic sleep diary
from day 0 to day 15
Subjective prospective assessment of sleepiness
Time Frame: from day 0 to day 15
Stanford Sleepiness Scale (SSS)
from day 0 to day 15

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Neurocenter of Southern Switzerland

Collaborators

Penn State University
Ente Ospedaliero Cantonale, Bellinzona
Parkinson Schweiz

Investigators

  • Principal Investigator: Pietro Luca Ratti, MD, PhD, Neurocenter of Southern Switzerland

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

March 16, 2016

Primary Completion (Actual)

May 31, 2019

Study Completion (Actual)

February 9, 2024

Study Registration Dates

First Submitted

March 12, 2016

First Submitted That Met QC Criteria

March 23, 2016

First Posted (Estimated)

March 30, 2016

Study Record Updates

Last Update Posted (Estimated)

February 13, 2024

Last Update Submitted That Met QC Criteria

February 9, 2024

Last Verified

February 1, 2024

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • EOC.NSI.LS.15.3.I

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

NO

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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