An interventional study of REMSA and NREMSA in Idiopathic Parkinson's Disease, sponsored by Neurocenter of Southern Switzerland. Completed at 1 site in Switzerland. Open to participants aged 35 Years and older. Per ClinicalTrials.gov, last updated 2018-08-27.
Sponsored by Neurocenter of Southern Switzerland · Not applicable, Interventional, and Other
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.
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).
4,487 studies on the registry are indexed under Parkinson Disease; 1,082 are open to participants now.
This study's enrollment of 24 is below the median of 40 across 3,294 interventional studies indexed under Parkinson Disease.
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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 the NREM sleep stage N2 will be the control intervention.
Behavioral: NREMSA
Awakening from REM sleep during the last hour of the sleep period
Awakening from N2 (NREM) sleep during the last hour of the sleep period
Overnight change in objective motor performance
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).
Time frame: 12 hours
Overnight change in subjective motor performance
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)
Time frame: 12 hours
Plan to share: No
This study is completed, as verified in Aug 2018. You cannot join it, but the record below documents what was studied.
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Neurocenter of Southern Switzerland