Criteria for discontinuing or modifying allocated interventions {11b}
ADVERSE EVENTS
Discontinuation or modification of allocated interventions is not planned. Discontinuation is possible in case of adverse events or if participants do not adhere to protocol requirements. In addition, if organizational or the participant’s situation require, a switch between pre-scheduled control and sleep deprivation conditions may be allocated at the participant’s arrival in the sleep laboratory. These two conditions only differ in the amount of scheduled sleep in the subsequent night. The modification in the allocated conditions may permit the efficient usage of resources, and thus reduce the total trial duration and facilitate intra-individual comparability of study specimens if collected in shorter time intervals.