Sleep, Awake & Move - Part I

Completed

• Conditions: Idiopathic Parkinson Disease

• Registration Number: NCT02723396
• Lead Sponsor: Neurocenter of Southern Switzerland

Brief Summary

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.

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 Timeline

• Study First Submitted: 2016-03-12
• Study Start: 2016-03-16
• Study First Submitted QC: 2016-03-23
• Study First Posted: 2016-03-30
• Primary Completion: 2019-05-31
• Status Verified: 2024-02
• Study Completion: 2024-02-09
• Last Update Submitted: 2024-02-09
• Last Update Posted: 2024-02-13

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 67

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 & Design

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
Objective prospective and repeated assessment of motor function	from day 0 to day 15	Finger tapping test

Secondary Outcome Measures

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

Trial Locations

Locations (1)

Sleep and Epilepsy center Department of Neurology, Neurocenter of Southern Switzerland; 🇨🇭 Lugano, Switzerland