Study type

Study type

Non-interventional study
Non-interventional study

Non-interventional study design

Cohort
Population studied

Age groups

Adults (18 to < 46 years)
Adults (46 to < 65 years)
Adults (65 to < 75 years)
Adults (75 to < 85 years)
Adults (85 years and over)

Estimated number of subjects

100
Study design details

Main study objective

Effect of insomnia in chronic pain patients: Relative improvement on the "Regensburger Insomnie Skala" (RIS, sum of points) versus baseline of 30% at minimum. AND/OR Absolute RIS-Verbesserung (sum of points) versus baseline by minimal 5 (minimal clinically important diffeerence, MCID).

Outcomes

Effect of insomnia in chronic pain patients: Relative improvement on the "Regensburger Insomnie Skala" (RIS, sum of points) versus baseline of 30% at minimum. AND/OR Absolute RIS-Verbesserung (sum of points) versus baseline by minimal 5 (minimal clinically important diffeerence, MCID). 1. Effect of THC/CBD on pain intensity (Reduction of mean pain intensity): 2. Evaluation of safety and tolerability of THC/CBD. 3. Effect of THC/CBD on Co-medication / reduction of polypharmacy.

Data analysis plan

No formal sample size calculation is performed for this exploratory study. Therefore, the interpretation of the change in sleep quality and pain perception will be modelled with a focus on effect size and confidence intervals to account for statistical error parameters. Exploratory analyses will be conducted for all patients participating in the study. Special (exploratory) subgroup analyses of interest are e.g. pain indication, gender. For univariate descriptive statistics, continuous data are summarised by sample size, mean, standard deviation, median and range, using additional descriptors where appropriate. Categorical data are counted by number and percentage of participants.