The PKG sleep study in patient’s with Parkinon’s disease, Version 1.0

• Research type

  Research Study

• Full title

  Pilot Study: Parkinson’s KinetiGraph (PKG) for monitoring of sleep pattern in patients with Parkinson`s disease – The PKG Sleep Study –

• IRAS ID

  142364

• Contact name

  Kallol Ray Chaudhuri

• Contact email

  ray.chaudhuri@nhs.net

• Sponsor organisation

  Research Office

• Research summary

  Disturbed nighttime sleep and excessive daytime sleepiness (EDS) is a key non motor symptom (NMS) and a major determinant of health related quality of life in patients with idiopathic Parkinson`s disease (PD). We aim to evaluate whether the Parkinson`s Kinetigraph (PKG) can be used as a reliable surrogate and objective marker of periods of sleep which may either unmask unknown episodes of sudden onset of sleep (SooS) or correlate with measures of EDS. The findings could be also extrapolated to disturbed nighttime sleep. Therefore we will focus on both daytime sleepiness and nighttime sleep. Subjects with PD and with historical accounts of and scale based evidence of EDS will be investigated as study population (PD-EDS). Subjects with PD and without historical and scale based evidence of EDS will be included as control population (PD-C).
  The PKG is a CE marked MHRA approved device and will be used within the intended purpose specified in the CE mark. It operates on wrist accelerometry and will assess the percentage distribution of dyskinesia (DK), bradykinesia (BK) and periods of immobility (equitable for sleep or dozing) over 24 hours in six consecutive days (Griffiths et al. 2012). Patients will additionally complete a diary recording motor function and sleep pattern over 24 hours in the same six consecutive days. Questionnaires / scores focusing on motor state, sleep and quality of life will be assessed in regular clinics. The results of the PKG and the diary reports will be compared and correlated and explore whether this technology could function as a “remote monitoring system” for undeclared sleep disturbances such as SooS, EDS and disturbed nighttime sleep in PD. Additionally, we aim to evaluate whether the PKG can be used to determine impulsivity as a pattern for disturbed nighttime sleep, based on a recent publication by Evans et al.

• REC name

  London - City & East Research Ethics Committee

• REC reference

  13/LO/1930

• Date of REC Opinion

  14 Feb 2014

• REC opinion

  Further Information Favourable Opinion