Table 1.
Moment | T0 | Baseline | T1 | Baseline | T2 | Intervention | T3 | Intervention | T4 | Wash-out | T5 | Wash-out | T6 |
Week | 0 | 1 | 2 | 3 | 4 | 5 | 6 | ||||||
Actiwatch | Continuous | Continuous | Charging | Continuous | Continuous | Charging | Continuous | Continuous | |||||
NPI-Q | T2 | T4 | T6 | ||||||||||
BANS-S | T0 | ||||||||||||
Patient characteristics | T0 | ||||||||||||
Sleep diary | Continuous | Continuous | Continuous | Continuous | Continuous | Continuous | |||||||
Status examination | T1 | T2 | T3 | T4 | T5 | T6 |
T0, the week previous to the measuring period: complete BANS-S and make an inventory of patient characteristics (CIRS); T1, status examination; T2, end of baseline period: complete NPI-Q and status examination; T3, status examination; T4, end of intervention period: complete NPI-Q and status examination; T5, status examination; T6, end of wash-out period: complete NPI-Q and status examination. Actigraphy is taking place continuously. At T2 and T4, the actiwatch will be charged for a short period (ca. 2 h).
A qualitative status examination will take place weekly (changes in medication, therapy, medical condition, means and measures, restlessness). The sleep diary will be filled in daily during the whole measuring period.