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

August 23, 2018 updated by: Pietro Luca Ratti, Neurocenter of Southern Switzerland

Awake & Move. Role of Nocturnal Sleep and Rapid Eye Movement Sleep at Morning Awakening on Sleep Benefit in Parkinson's Disease. An Interventional Cross-over 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. The aim of this study is to test the hypothesis that objective and/or subjective improvement of motor function might be due to a carry-over effect of Rapid Eye Movements (REM) sleep at awakening from this sleep phase.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

Detailed Description

The "Awake & Move" study is the second part of the Sleep, Awake & Move project. This study will be conducted in a subgroup of unselected, consecutive patients having completed the part I of the Sleep, Awake & Move project (i.e. the "Sleep & Move" study). The investigators plan to explore the carry-over effect of REM sleep on motor function in a subgroup of PD subjects p. In this interventional study the investigators expect to induce SB by awakening the subjects from nocturnal REM sleep in a sleep laboratory setting, but not from Non-Rapid Eye Movements (NREM) sleep (control intervention).

Study Type

Interventional

Enrollment (Actual)

24

Phase

  • Not Applicable

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

No

Genders Eligible for Study

All

Description

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

Exclusion Criteria:

  • Atypical parkinsonian syndrome
  • Cognitive impairment (MMSE ≥ 26)
  • Deep brain stimulation
  • History of cerebro-vascular disease, epilepsy, or other disabling neurological diseases
  • Psychiatric disorders, excepting mild depression
  • 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.
  • subjects with (a) sleep-disordered breathing [Respiratory Disorder Index (RDI)≥ 5] and (b) with no clear-cut distinction of REM and NREM sleep, based on a video-polysomongraphical recording.

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

  • Primary Purpose: Other
  • Allocation: Non-Randomized
  • Interventional Model: Crossover Assignment
  • Masking: Triple

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Experimental: REM Sleep Awakening (REMSA)
The investigators will actively awaken each subject from nocturnal REM sleep in a sleep laboratory setting, in the hour preceding her/his habitual wake time.
Behavioral: REMSA
Awakening from REM sleep during the last hour of the sleep period
Experimental: NREM Sleep Awakening (NREMSA)
Awakening from the NREM sleep stage N2 will be the control intervention.
Behavioral: NREMSA
Awakening from N2 (NREM) sleep during the last hour of the sleep period

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Overnight change in objective motor performance
Time Frame: 12 hours
The change of objective measures of morning motor performance at awakening from REM sleep compared to the morning motor performance at awakening from NREM sleep (stage N2), within the same subjects, by mean of an electronic finger tapping test and the Movement Disorders Society Unified Parkinson's Disease Rating Scale motor examination (MDS-UPDRS-III).
12 hours

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Overnight change in subjective motor performance
Time Frame: 12 hours
The change of subjective measures of morning motor performance at awakening from REM sleep compared to the morning motor performance at awakening from NREM sleep (stage N2), within the same subjects, by mean of the Scale for Outcome in Parkinson's Disease Diary Card (SCOPA-DC) and a visual analogue scale (VAS)
12 hours

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 3, 2016

Primary Completion (Actual)

January 12, 2018

Study Completion (Actual)

July 27, 2018

Study Registration Dates

First Submitted

March 12, 2016

First Submitted That Met QC Criteria

March 12, 2016

First Posted (Estimate)

March 16, 2016

Study Record Updates

Last Update Posted (Actual)

August 27, 2018

Last Update Submitted That Met QC Criteria

August 23, 2018

Last Verified

August 1, 2018

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • EOC.NSI.LS.15.3.II

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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